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Evidence Base

Evidence Base

Oesophageal Doppler Monitoring (ODM) has gained support from a number of clinical and regulatory bodies, both within the UK and Internationally, due to the robust evidence available, demonstrating reduced post-operative complications and hospital length of stay;

Evidence Table

Bibliography

Enhanced Recovery Recommendations

Guidelines

Meta-analysis

NHS Standard Contract

 

 

 

Meta-analysis of IOFM Outcome Benefit

This meta-analysis has been prepared rigorously and objectively by Deltex Medical’s lead scientist. It is designed to be a valuable resource to everyone interested in the evidence for Intraoperative Fluid Management (IOFM) and may be downloaded and used without any need for permission.

Click here to download the full Meta-analysis

This meta-analysis of published outcome evidence of IOFM using a Stroke Volume Optimisation (‘SVO’) strategy confirms that ODM is the only technology that can reduce both the incidence of complications and the length of hospital stay during surgery.

Studies of ODM-guided SVO for IOFM demonstrate a reduction in the incidence of postoperative complications, whereas studies using an arterial pressure based device (PPWA) to guide SVO for IOFM did not:

Comp 11.12

ODM-guided IOFM demonstrated a 1.1-day reduction in length of hospital stay, an outcome not obtained with PPWA technologies.

Deltex Medical plans to update the meta-analysis as it becomes aware of further studies newly published in peer reviewed journals to create a ‘living’ up to date meta-analysis.

LOS 11.12

Visitors to this page are invited to contact the author by email, should you wish to highlight any new or published studies which may merit inclusion: meta-analysis@deltexmedical.com

There is a large body of evidence to support the use of Deltex Medical’s technology. This includes a NICE recommendation, Randomised Controlled Trials (RCTs), published Audit studies, Reviews and Meta-analyses, Health Technology Assessments, and Case Histories. Click here for a pdf version of the Deltex Medical Bibliography.

Clinical Evidence

Intraoperative: ODM RCT

Mythen, M.G. and Webb, A.R., Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg, 1995. 130(4): p. 423-9.

Sinclair, S., James, S., and Singer, M., Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ, 1997. 315(7113): p. 909-12.

Gan, T.J., Soppitt, A., Maroof, M., el-Moalem, H., Robertson, K.M., Moretti, E., Dwane, P., and Glass, P.S., Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology, 2002. 97(4): p. 820-6.

Venn, R., Steele, A., Richardson, P., Poloniecki, J., Grounds, M., and Newman, P., Randomized controlled trial to investigate influence of the fluid challenge on duration of hospital stay and perioperative morbidity in patients with hip fractures. Br J Anaesth, 2002. 88(1): p. 65-71.

Wakeling, H.G., McFall, M.R., Jenkins, C.S., Woods, W.G., Miles, W.F., Barclay, G.R., and Fleming, S.C., Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth, 2005. 95(5): p. 634-42.

Noblett, S.E., Snowden, C.P., Shenton, B.K., and Horgan, A.F., Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection. The Br J Surg, 2006. 93(9): p. 1069-76.

Senagore, A.J.E., Emery, T., Luchtefeld, M., Kim, D., Dujovny, N., Hoedema, R., Fluid management for laparoscopic colectomy: a prospective, randomized assessment of goal-directed administration of balanced salt solution or hetastarch coupled with an enhanced recovery program. Dis Colon Rectum, 2009. 52(12): p. 1935-40.

Pillai, P.M., McEleavy, I., Gaughan, M., Snowden, C., Nesbitt, I., Durkan, G., Johnson, M., Cosgrove, J., Thorpe, A., A double-blind randomized controlled clinical trial to assess the effect of Doppler optimized intraoperative fluid management on outcome following radical cystectomy. J Urol, 2011. 186(6): p. 2201-6.

Brandstrup, B., Svendsen, P.E., Rasmussen, M., Belhage, B., Rodt, S.A., Hansen, B., Moller, D.R., Lundbech, L.B., Andersen, N., Berg, V., Thomassen, N., Andersen, S.T., and Simonsen, L., Which goal for fluid therapy during colorectal surgery is followed by the best outcome: near-maximal stroke volume or zero fluid balance? Br J Anaesth, 2012. 109(2): p. 191-9.

Challand, C.S., Struthers, R., Sneyd, J. R., Erasmus, P. D., Mellor, N., Hosie, K. B., Minto, G., Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth, 2012. 108(1): p. 53-62.

Srinivasa, S., Taylor, M.H., Singh, P.P., Yu, T.C., Soop, M., and Hill, A.G., Randomized clinical trial of goal-directed fluid therapy within an enhanced recovery protocol for elective colectomy. Br J Surg, 2013. 100(1): p. 66-74.

Zakhaleva, J., Tam, J., Denoya, P.I., Bishawi, M., and Bergamaschi, R., The impact of intravenous fluid administration on complication rates in bowel surgery within an enhanced recovery protocol: a randomized controlled trial. Colorectal Dis, 2013. 15(7): p. 892-9.

McKenny, M., Conroy, P., Wong, A., Farren, M., Gleeson, N., Walsh, C., O’Malley, C., and Dowd, N., A randomised prospective trial of intra-operative oesophageal Doppler-guided fluid administration in major gynaecological surgery. Anaesthesia, 2013.

El Sharkawy, O.A., Refaat, E.K., Ibraheem, A.E.M., Mahdy, W.R., Fayed, N.A., Mourad, W.S., Abd Elhafez, H.S., and Yassen, K.A., Transoesophageal Doppler compared to central venous pressure for perioperative hemodynamic monitoring and fluid guidance in liver resection. Saudi J Anaesth, 2013. 7(4): p. 378-86.

Intraoperative: ODM Audit

Kuper, M., Gold, S.J., Callow, C., Quraishi, T., King, S., Mulreany, A., Bianchi, M., and Conway, D.H., Intraoperative fluid management guided by oesophageal Doppler monitoring. BMJ, 2011. 342: p. d3016.

Feldheiser, A., Conroy, P., Bonomo, T., Cox, B., Ruiz Garces, T., and Spies, C., Development and feasibility study of an algorithm for intraoperative goal-directed haemodynamic management in noncardiac surgery. J Int Med Res, 2012. 40(4): p. 1227-41.

Chattopadhyay, S., Mittal, S., Christian, S., Terblanche, A.L., Patel, A., Biliatis, I., Kucukmetin, A., Naik, R., and Galaal, K., The role of intraoperative fluid optimization using the esophageal Doppler in advanced gynecological cancer: early postoperative recovery and fitness for discharge. Int J Gynecol Cancer, 2013. 23(1): p. 199-207.

Figus, A., Wade, R.G., Oakey, S., and Ramakrishnan, V.V., Intraoperative esophageal Doppler hemodynamic monitoring in free perforator flap surgery. Ann Plast Surg, 2013. 70(3): p. 301-7.

Intraoperative: ODM Unpublished

Shi, C., Morse, L.S., Douning, L.K., Chi, L., and Jessen, M.E. Optimizing intraoperative volume management during coronary bypass surgery. American Society of Anesthesiologists, 2000: p. A-347.

Dodd, T.E.M., McCormack, R.N., Dorman, F., Green, R., Bromilow, J. Using the oesophageal Doppler monitor in elective colorectal surgery: is it worth it? [Poster]. in Annual Meeting of Wessex Anaesthetists in Training. 2004. Poole, UK.

McKenny, M., Dowd, N., and O’Malley, C. Oesophageal Doppler Monitor guided fluid management in laparoscopic gastrointesintal surgery. in Anaesthesia & Perioperative Medicine. 2011. Dingle, Ireland.

Munoz, C.A.F., Rojas, J.L.T., Bermudez, O.I.G., Rios, D.E.M., Escobar, E.M. Intraoperative oesophageal Doppler during emergency abdominal surgery [Abstract #966]. in World Congress of Anaesthesiologists. 2012. Buenos Aires.

Intraoperative: Other ODM

Conway, D.H., Mayall, R., Abdul-Latif, M.S., Gilligan, S., Tackaberry, C., Randomised controlled trial investigating the influence of intravenous fluid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia, 2002. 57(9): p. 845-9.

Mannova, J.H., Silhart, Z., Sevcik, P., and Prokes, A., Perioperative haemodynamic monitoring by oesophageal Doppler improves outcome of patients with abdominal aortic aneurysm repair. Bratislavske lekarske listy, 2013. 114(2): p. 78-83.

Postoperative/ICU: ODM RCT

McKendry, M., McGloin, H., Saberi, D., Caudwell, L., Brady, A.R., and Singer, M., Randomised controlled trial assessing the impact of a nurse delivered, flow monitored protocol for optimisation of circulatory status after cardiac surgery. BMJ, 2004. 329(7460): p. 258.

El Sharkawy, O.A., Refaat, E.K., Ibraheem, A.E.M., Mahdy, W.R., Fayed, N.A., Mourad, W.S., Abd Elhafez, H.S., and Yassen, K.A., Transoesophageal Doppler compared to central venous pressure for perioperative hemodynamic monitoring and fluid guidance in liver resection. Saudi J Anaesth, 2013. 7(4): p. 378-86.

Postoperative/ICU: ODM Unpublished

van Dellen, J., McCorkell, S., and Williams, A., Randomised controlled trial of extended post-operative goal-directed fluid therapy using oesophageal doppler within an enhanced recovery programme for elective colorectal patients [Abstract P056]. Colorectal Dis, 2013. 15(Suppl 1): p. 30.

Postoperative/ICU: Other ODM

Chytra, I., Pradl, R., Bosman, R., Pelnar, P., Kasal, E., Zidkova, A., Esophageal Doppler-guided fluid management decreases blood lactate levels in multiple-trauma patients: a randomized controlled trial. Crit Care, 2007. 11(1): p. R24.

Systematic Reviews and Meta-analyses

Abbas, S.M., Hill, A. G., Systematic review of the literature for the use of oesophageal Doppler monitor for fluid replacement in major abdominal surgery. Anaesthesia, 2008. 63(1): p. 44-51.

Phan, T.D., Ismail, H., Heriot, A. G., Ho, K. M., Improving perioperative outcomes: fluid optimization with the esophageal Doppler monitor, a metaanalysis and review. J Am Coll Surg, 2008. 207(6): p. 935-41.

Walsh, S.R., Tang, T., Bass, S., and Gaunt, M.E., Doppler-guided intra-operative fluid management during major abdominal surgery: systematic review and meta-analysis. Int J Clin Pract, 2008. 62(3): p. 466-70.

Giglio, M.T., Marucci, M., Testini, M., and Brienza, N., Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth, 2009. 103(5): p. 637-46.

Mowatt, G., Houston, G., Hernandez, R., de Verteuil, R., Fraser, C., Cuthbertson, B., Vale, L., Systematic review of the clinical effectiveness and cost-effectiveness of oesophageal Doppler monitoring in critically ill and high-risk surgical patients. Health Technol Assess, 2009. 13(7): p. iii-iv, ix-xii, 1-95.

Dalfino, L., Giglio, M.T., Puntillo, F., Marucci, M., and Brienza, N., Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care, 2011. 15(3): p. R154.

Hamilton, M.A., Cecconi., M., Rhodes, A., A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg, 2011. 112(6): p. 1392-402.

Maeso, S., Callejo, D., Hernandez, R., Blasco, J.A., and Andradas, E., Esophageal Doppler monitoring during colorectal resection offers cost-effective improvement of hemodynamic control. Value Health, 2011. 14(6): p. 818-26.

Giglio, M., Dalfino, L., Puntillo, F., Rubino, G., Marucci, M., and Brienza, N., Haemodynamic goal-directed therapy in cardiac and vascular surgery. A systematic review and meta-analysis. Interact Cardiovas Thorac Surg, 2012. 15(5): p. 878-87.

Grocott, M.P., Dushianthan, A., Hamilton, M.A., Mythen, M.G., Harrison, D., and Rowan, K., Perioperative increase in global blood flow to explicit defined goals and outcomes following surgery. Cochrane Database Syst Rev, 2012. 11: p. CD004082.

Validation

Singer, M., Clarke, J., Bennett, E. D., Continuous hemodynamic monitoring by esophageal Doppler. Crit Care Med, 1989. 17(5): p. 447-52.

Singer, M. and Bennett, E.D., Noninvasive optimization of left ventricular filling using esophageal Doppler. Crit Care Med, 1991. 19(9): p. 1132-7.

Klotz, K.F., Klingsiek, S., Singer, M., Wenk, H., Eleftheriadis, S., Kuppe, H., and Schmucker, P., Continuous measurement of cardiac output during aortic cross-clamping by the oesophageal Doppler monitor ODM 1. Br J Anaesth, 1995. 74(6): p. 655-60.

Keyl, C., Rodig, G., Lemberger, P., and Hobbhahn, J., A comparison of the use of transoesophageal Doppler and thermodilution techniques for cardiac output determination. Eur J Anaesthesiol, 1996. 13(2): p. 136-42.

Krishnamurthy, B., McMurray, T.J., and McClean, E., The peri-operative use of the oesophageal Doppler monitor in patients undergoing coronary artery revascularisation. A comparison with the continuous cardiac output monitor. Anaesthesia, 1997. 52(7): p. 624-9.

Colbert, S., O’Hanlon, D.M., Duranteau, J., and Ecoffey, C., Cardiac output during liver transplantation. Can J Anaesth, 1998. 45(2): p. 133-8.

Lefrant, J.Y., Bruelle, P., Aya, A.G., Saissi, G., Dauzat, M., de La Coussaye, J.E., and Eledjam, J.J., Training is required to improve the reliability of esophageal Doppler to measure cardiac output in critically ill patients. Intensive Care Med, 1998. 24(4): p. 347-52.

Valtier, B., Cholley, B.P., Belot, J.P., de la Coussaye, J.E., Mateo, J., and Payen, D.M., Noninvasive monitoring of cardiac output in critically ill patients using transesophageal Doppler. Am J Respir Crit Care Med, 1998. 158(1): p. 77-83.

Baillard, C., Cohen, Y., Fosse, J.P., Karoubi, P., Hoang, P., and Cupa, M., Haemodynamic measurements (continuous cardiac output and systemic vascular resistance) in critically ill patients: transoesophageal Doppler versus continuous thermodilution. Anaesth Intensive Care, 1999. 27(1): p. 33-7.

DiCorte, C.J., Latham, P., Greilich, P.E., Cooley, M.V., Grayburn, P.A., and Jessen, M.E., Esophageal Doppler monitor determinations of cardiac output and preload during cardiac operations. Ann Thorac Surg, 2000. 69(6): p. 1782-6.

Penny, J.A., Anthony, J., Shennan, A.H., De Swiet, M., and Singer, M., A comparison of hemodynamic data derived by pulmonary artery flotation catheter and the esophageal Doppler monitor in preeclampsia. Am J Obstet Gynecol, 2000. 183(3): p. 658-61.

Leather, H.A. and Wouters, P.F., Oesophageal Doppler monitoring overestimates cardiac output during lumbar epidural anaesthesia. Br J Anaesth, 2001. 86(6): p. 794-7.

Su, N.Y., Huang, C.J., Tsai, P., Hsu, Y.W., Hung, Y.C., Cheng, C.R., Cardiac output measurement during cardiac surgery: esophageal Doppler versus pulmonary artery catheter. Acta Anaesthesiol Sin, 2002. 40(3): p. 127-33.

Jaeggi, P., Hofer, C.K., Klaghofer, R., Fodor, P., Genoni, M., and Zollinger, A., Measurement of cardiac output after cardiac surgery by a new transesophageal Doppler device. J Cardiothorac Vasc Anesth, 2003. 17(2): p. 217-20.

Roeck, M., Jakob, S.M., Boehlen, T., Brander, L., Knuesel, R., and Takala, J., Change in stroke volume in response to fluid challenge: assessment using esophageal Doppler. Intensive Care Med, 2003. 29(10): p. 1729-35.

Seoudi, H.M., Perkal, M.F., Hanrahan, A., and Angood, P.B., The esophageal Doppler monitor in mechanically ventilated surgical patients: does it work? J Trauma, 2003. 55(4): p. 720-5; discussion 5-6.

Dark, P.M., Singer, M., The validity of trans-esophageal Doppler ultrasonography as a measure of cardiac output in critically ill adults. Intensive Care Med, 2004. 30(11): p. 2060-6.

Monnet, X., Rienzo, M., Osman, D., Anguel, N., Richard, C., Pinsky, M.R., and Teboul, J.L., Esophageal Doppler monitoring predicts fluid responsiveness in critically ill ventilated patients. Intensive Care Med, 2005. 31(9): p. 1195-201.

Chew, H.C., Devanand, A., Phua, G.C., and Loo, C.M., Oesophageal Doppler ultrasound in the assessment of haemodynamic status of patients admitted to the medical intensive care unit with septic shock. Ann Acad Med Singapore, 2009. 38(8): p. 699-703.

Phan, T.D., Kluger, R., Wan, C., Wong, D., and Padayachee, A., A comparison of three minimally invasive cardiac output devices with thermodilution in elective cardiac surgery. Anaesth Intensive Care, 2011. 39(6): p. 1014-21.

Guinot, P.G., de Broca, B., Abou Arab, O., Diouf, M., Badoux, L., Bernard, E., Lorne, E., and Dupont, H., Ability of stroke volume variation measured by oesophageal Doppler monitoring to predict fluid responsiveness during surgery. Br J Anaesth, 2013. 110(1): p. 28-33.

Monnet, X., Robert, J.M., Jozwiak, M., Richard, C., and Teboul, J.L., Assessment of changes in left ventricular systolic function with oesophageal Doppler. Br J Anaesth, 2013.

Paediatrics

Note: The items in blue are papers where ODM was used or reviewed. Items in black either mention ODM or are documents Deltex Medical are working with to refine the system and develop an understanding of its place in the clinical setting.

Krovetz LJ, McLoughlin TG, Mitchell MB and Schiebler GL. Hemodynamic Findings in Normal Children. Res. 1967. 1: 122-130

Grenadier E, Oliveira C, Allen HD, Sahn DJ, Barron JV, Vales-Cruz LM and Goldberg SJ. Normal Intracardiac and Great Vessel Doppler Flow Velocities in Infants and Children. 1984. 4(2): 343-350

Hanseus K, Björkhem G and Lundrtöm NR. Cardiac Function in Healthy Infants and Children: Doppler Echocardiographic Evaluation. Pediatr Cardiol. 15:211-218

Murdoch IA, Marsh MJ, Tibby SM, McLuckie A. Continuous haemodynamic monitoring in children: use of transoesophageal Doppler. Acta Paediatr. 84: 761-764

Tibby S, Hatherill M, Marsh MJ and Murdoch IA. Clinicians’ ability to estimate cardiac index in ventilated children and infants. Archives of Disease in Childhood. 77:516-518

Childs C, Goldring S, Tann W and Hillier VF. Suprasternal Doppler ultrasound for assessment of stroke distance. Arch Dis Child. 79:251-255

Tibby SM, Hatherill M, Murdoch IA. Use of transoesophageal Doppler ultrasonography in ventilated pediatric patients: Derivation of cardiac output. Crit Care Med. 2000. 28:2045-2050

Wodey E, Carre F, Beneux X, Schaffuser A and Ecoffey C. Limits of Corrected Flow Time to Monitor Hemodynamic status in Children. Journal of Clincial Monitoring and Computing. 16: 223-228

Sohn S and Kim HS. Doppler Aortic Flow velocity Measurement in Healthy Children. J Korean Med. 16: 140-4

Tibby SM, Hatherill M, Durward A, Murdoch IA. Are transoesophageal Doppler parameters a reliable guide to paediatric haemodynamic status and fluid management? Intensive Care Med. 2001. 27:201-205

Carcillo JA and Fields AI. Clinical practice parameters for hemodynamic support of pediatric and neonatal patients in septic shock. Jornal de Pediatria. 78(6): 449-466

Larousse E, Asehnoune K, Datayet B, Albaladejo P, Dubousset AM, Gauthier F and Benhamou D.The hemodynamic effects of pediatric caudal anesthesia assessed by esophageal Doppler. Anesth Analg. 2002 May; 94(5): 1165-8

Mohan UR, Britto J, Habibi P, Munter C, Nadel S. Noninvasive Measurement of Cardiac Output in Critically Ill Children. Journal Pediatric Cardiology. 23(1): 58-61

Tibby SM and Murdoch IA. Measurement of cardiac output and tissue perfusion. Curr Opin Pediatr 2002, 14:303-309

Chew MS and Poelaert J. Accuracy and repeatability of pediatric cardiac output measurement using Doppler: 20-year review of the literature. Intensive Care Medicine. 2003. 29(11): 1889-894

Tibby SM, Murdoch IA. Monitoring cardiac function in intensive care. Arch Dis Child. 88:46-52

King SL and Lim MS. The Use of the Oesophageal Doppler Monitor in the Intensive Care Unit. Critical Care and Resuscitation. 6: 113-122

Raux O, Rochette A, Morau E, Dadure C, Vergnes C and Capdevila X. The effects of spread of block and adrenaline on cardiac output after epidural anesthesia in young children: a randomized, double-blind, prospective study. Anesth Analg. 98(4): 948-55

Almenrader N and Patel D. Spinal fusion surgery in children with non-idiopathic scoliosis: is there a need for routine postoperative ventilation? 2006. 97(6): 851-857

Hack H. Case report. Use of the Esophageal Doppler Machine to help guide the intraoperative management of two children with pheochromocytoma. Pediatric Anesthesia. 16:867-87

Monsel A, Salvat-Toussaint A, Durand P, Haas V, Baujard C, Rouleau P, El Aouadi S, Benhamou D and Asehnoune K. The Transesophageal Doppler and Hemodynamic Effects of Epidural Anesthesia in Infants Anesthetized with Sevoflurane and Sufentanil. International Anesthesia Research Society. 2007. 105(7): 46-50

Rowlands H, Bagshaw O and Duncan H. Does Trans-Oesophageal Doppler Cardiac Output Measurement Change Clinical Management Strategy? 2007 Poster

Knirsch W, Kretschmar O, Tomaske M, Stutz K, Nagdyman N, Balmer C, Schmitz A, Bettex D, Berger F, Bauersfeld U and Weiss M. Cardiac output measurement in children: comparison of the Ultrasound Cardiac Output Monitor with thermodilution cardiac output measurement. Intensive Care Med. 34(6): 1060-4

Mukhtar AM and Obayah G. Esophageal Doppler Monitor: A New Tool in Monitoring Video Assisted Thorascopic Surgery for Ligation of Patent Ductus Arteriosus. Anesthesia & Analgesia. 107(1) 346-347

Schubert S, Schmitz T, Weiss M, Nagdyman N, Huebler M, Alexi-Meskishvili V, Berger F and Stiller B. Continuous, non-invasive techniques to determine cardiac output in children after cardiac surgery: evaluation of transesophageal Doppler and electric velocimetry. J Clin Monit Comput. 22(4): 299-307

Brierley J et al. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 37(2) 666-688

Absi MA, Lutterman J and Wetzel GT. Noninvasive cardiac output monitoring in the pediatric intensive care unit. Current Opinion in Cardiology. 25: 77-79

Fleck T, Schubert S, Stiller B, Redlin M, Ewert P, Nagdyman N and Berger F, Capability of a new paediatric oesophageal Doppler monitor to detect changes in cardiac output during testing of external pacemakers after cardiac surgery. J Clin Monit Comput. 25(6): 419-25

Lemson J, Nusmeier A and van de Hoeven JG. Advanced Hemodynamic Monitoring in Critically Ill Children. 2011. 128: 560-571

Pereira de Souza Neto E, Grousson S, Duflo F, Ducreux C, Joly H, Convert J, Mottolese C, Dailler F and Cannesson M. Predicting fluid responsiveness in mechanically ventilated children under general anaesthesia using dynamic parameters and transthoracic echocardiography. BJA 106(6): 856-864

Lechner E, Hofer A, Leitner-Peneder G,, Mair R, Weinzettel R, Rehak P and Gombotz H. Levosimendan versus milrinone in neonates and infants after corrective open-heart surgery: a pilot study. Pediatr Crit Care Med. 2012 Sep;13(5):542-8.

Brown Z, Görges M, Cooke E, Malberbe S, Dumont G and Ansermino J. Changes in cardiac index and blood pressure on positioning children prone for scoliosis surgery. 2013. 68: 742-746

Galante D and Melchionda M. Transesophageal Doppler ultrasound and hemodynamic monitoring using regional anesthesia in pediatrics. Ultrasounds Anesthesia Journal. 1: 1-5

Gan H, Cannesson M, Chandler JR and Ansermino JM. Predicting Fluid Responsivesness in Children: A Systematic Review. Anesthesia & Analgesia. 117(6): 1380- 1392

Dubost C, Bouglé A, Hallynck C, Le Dorze M, Roulleau P, Baujard C and Benhamou D. Comparison of monitoring performance of bioreactance versus esophageal Doppler in pediatric patients. Indian Journal of Crit Care Med. 2015 19(1): 3-8

Ibrahim E, Yassein T and Morad W. The beneficial values of transoesophageal Doppler in intraoperative fluid guidance versus standard clinical monitoring parameters in infants undergoing Kasai operation. E.J. Annesth. 23(2): 205-211

Weber T, Wagner T, Neuman K and Deusch E. Low Predictability of Three Different Noninvasive Methods to determine Fluid responsiveness in Critically Ill Children. Pediatric Critical Care. 16(3): 89-94

Desgranges F P, Desebbe O, Pereira de Souza Neto E, Raphael D, Chassard D. Respiratory variation in aortic blood flow peak velocity to predict fluid responsiveness in mechanically ventilated children: a systematic review and meta-analysis. Paediatr Anaesth. 2016 Jan;26(1):37-47

Kuiper J, Tibboel D and Ince C. The vulnerable microcirculation in the critically ill pediatric patient. 2016. Critical Care 20(352): 1-12

Comparison with other technologies

Meng, L., Tran, N.P., Alexander, B.S., Laning, K., Chen, G., Kain, Z.N., Cannesson, M., The impact of phenylephrine, ephedrine, and increased preload on third-generation Vigileo-FloTrac and esophageal doppler cardiac output measurements. Anesth Analg, 2011. 113(4): p. 751-7.

Conway, D.H., Hussain, O.A., and Gall, I., A comparison of noninvasive bioreactance with oesophageal Doppler estimation of stroke volume during open abdominal surgery: An observational study. Eur J Anaesthesiol, 2013. 30(8): p. 501-8.

Nordstrom, J., Hallsjo-Sander, C., Shore, R., and Bjorne, H., Stroke volume optimization in elective bowel surgery: a comparison between pulse power wave analysis (LiDCOrapid) and oesophageal Doppler (CardioQ). Br J Anaesth, 2013. 110(3): p. 374-80.

Davies, S.J., Minhas, S., Wilson, R.J., Yates, D., and Howell, S.J., Comparison of stroke volume and fluid responsiveness measurements in commonly used technologies for goal-directed therapy. J Clin Anesth, 2013.

Relevant Review Studies

Laupland, K.B. and Bands, C.J., Utility of esophageal Doppler as a minimally invasive hemodynamic monitor: a review. Can J Anaesth, 2002. 49(4): p. 393-401.

Cholley, B.P. and Singer, M., Esophageal Doppler: noninvasive cardiac output monitor. Echocardiography, 2003. 20(8): p. 763-9.

King, S.L. and Lim, M.S., The use of the oesophageal Doppler monitor in the intensive care unit. Crit Care Resusc, 2004. 6(2): p. 113-22.

Grocott, M.P., Mythen, M.G., and Gan, T.J., Perioperative fluid management and clinical outcomes in adults. Anesth Analg, 2005. 100(4): p. 1093-106.

Roche, A.M., Miller, T.E., and Gan, T.J., Goal-directed fluid management with trans-oesophageal Doppler. Best Pract Res Clin Anaesthesiol, 2009. 23(3): p. 327-34.

Schober, P., Loer, S.A., and Schwarte, L.A., Perioperative hemodynamic monitoring with transesophageal Doppler technology. Anesth Analg, 2009. 109(2): p. 340-53.

Schober, P., Loer, S.A., and Schwarte, L.A., Transesophageal Doppler devices: A technical review. J Clin Mon Comput, 2009. 23(6): p. 391-401.

Singer, M., Oesophageal Doppler. Curr Opin Crit Care, 2009. 15(3): p. 244-8.

Singer, M., Oesophageal Doppler monitoring: should it be routine for high-risk surgical patients? Curr Opin Anaesthesiol, 2011. 24(2): p. 171-6.

Marik, P.E., Noninvasive cardiac output monitors: a state-of the-art review. J Cardiothorac Vasc Anesth, 2013. 27(1): p. 121-34.

ODM+

Sun, J.X., Reisner, A.T., Saeed, M., and Mark, R.G., Estimating Cardiac Output from Arterial Blood Pressure Waveforms: a Critical Evaluation using the MIMIC II Database, Harvard-MIT Division of Health Sciences and Technology, MIT: Cambridge, MA, USA.

Sun, J.X., Cardiac output estimation using aterial blood pressure waveforms, in Electrical Engineering and Computer Science 2006, Massachusettes Institute of Technology.

Sun, J.X., Reisner, A.T., Saeed, M., Heldt, T., and Mark, R.G., The cardiac output from blood pressure algorithms trial. Crit Care Med, 2009. 37(1): p. 72-80.

Caillard, A., Dubreuil, G., M’Bakulu, E., Tantot, A., Bart, F., Gayat, E., Madadaki, C., Vallee, F., and Mebazaa, A., Comparaison du débit cardiaque mesuré par doppler œsophagien et par 9 algorithmes d’analyse du contour de l’onde de pouls au cours d’épreuves thérapeutiques. Ann Fr Anesth Reanim, 2013. 32(S1): p. A389.

Monge Garcia, M.I., Gracia Romero, M., Gil Cano, A., Rhodes, A., Grounds, R.M., and Cecconi, M., Impact of arterial load on the agreement between pulse pressure analysis and esophageal Doppler. Crit Care, 2013. 17(3): p. R113.

Editorials/Letters

Ghosh, S., Arthur, B., and Klein, A.A., NICE guidance on CardioQ(TM) oesophageal Doppler monitoring. Anaesthesia, 2011. 66(12): p. 1081-3. [and responses]

Campbell, B., Innovation, NICE, and CardioQ. Br J Anaesth, 2012. 108(5): p. 726-9.

Pinsky, M.R., O’Brien, T., Green, D., and Jonas, M., Technology comparison studies require precise reference controls to be valid [Letter]. Br J Anaesth, 2012. [and response]

Morris, C., Oesophageal Doppler monitoring, doubt and equipoise: evidence based medicine means change. Anaesthesia, 2013.

Physiology and the need for IOFM

Fiddian-Green, R.G., Splanchnic ischaemia and multiple organ failure in the critically ill. Ann R Coll Surg Engl, 1988. 70(3): p. 128-34.

Deitch, E.A., The role of intestinal barrier failure and bacterial translocation in the development of systemic infection and multiple organ failure. Arch Surg, 1990. 125(3): p. 403-4.

Shoemaker, W.C.A., Apple, P. L.; Kram, H. B., Role of oxygen debt in the development of organ failure sepsis, and death in high-risk surgical patients. Chest, 1992. 102(1): p. 208-15.

Hamilton-Davies, C., Mythen, M.G., Salmon, J.B., Jacobson, D., Shukla, A., and Webb, A.R., Comparison of commonly used clinical indicators of hypovolaemia with gastrointestinal tonometry. Intensive Care Med, 1997. 23(3): p. 276-81.

Khuri, S.F.H., W. G.; DePalma, R. G.; Mosca, C.; Healey, N. A.; Kumbhani, D. J., Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg, 2005. 242(3): p. 326-41; discussion 41-3.

Kimberger, O., Arnberger, M., Brandt, S., Plock, J., Sigurdsson, G.H., Kurz, A., and Hiltebrand, L., Goal-directed colloid administration improves the microcirculation of healthy and perianastomotic colon. Anesthesiology, 2009. 110(3): p. 496-504.

Bundgaard-Nielsen, M.J., C. C.; Secher, N. H.; Kehlet, H., Functional intravascular volume deficit in patients before surgery. Acta Anaesthesiol Scand, 2010. 54(4): p. 464-9.

Enhanced Recovery

Kehlet, H., Multimodal approach to control postoperative pathophysiology and rehabilitation. British journal of anaesthesia, 1997. 78(5): p. 606-17.

Fearon, K.C., Ljungqvist, O., Von Meyenfeldt, M., Revhaug, A., Dejong, C.H., Lassen, K., Nygren, J., Hausel, J., Soop, M., Andersen, J., Kehlet, H., Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr, 2005. 24(3): p. 466-77.

Lassen, K., Soop, M., Nygren, J., Cox, P.B., Hendry, P.O., Spies, C., von Meyenfeldt, M.F., Fearon, K.C., Revhaug, A., Norderval, S., Ljungqvist, O., Lobo, D.N., and Dejong, C.H., Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg, 2009. 144(10): p. 961-9.

Ramirez, J.M., Blasco, J.A., Roig, J. V., Maeso-Martinez, S., Casal, J.E., Esteban, F., Lic, D.C., Enhanced recovery in colorectal surgery: a multicentre study. BMC Surg, 2011. 11: p. 9.

Mythen, M.G., Swart, M., Acheson, N., Crawford, R., Jones, K., Kuper, M., McGrath, J. S., Horgan, A.F., Perioperative fluid management: Consensus statement from the enhanced recovery partnership. Perioperative Medicine, 2012. 1(2).

NHS Enhanced Recovery Partnership Programmme. Fulfilling the potential: A better journey for patients and a better deal for the NHS, 2012.  NHS Improvement

Other

NHS Technology and Adoption Centre (NTAC). ‘How to why to’ guide – Doppler Guided Intraoperative Fluid Management. NTAC

Powell-Tuck, J., Gosling, P., Lobo, D. N., Allison, S.P., Carlson, G.L., Gore, M., Lewington, A.J., Pearse, R.M., Mythen, M.G., British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients.

National Institute for Health and Clinical Excellence (NICE). CardioQ-ODM Oesophageal Doppler Monitor. NICE MTG3, 2011.  https://guidance.nice.org.uk/MTG3

Innovation Health and Wealth: Accelerating Adoption and Diffusion in the NHS. . https://www.dh.gov.uk/publications, 2011.

For any enquiries or requests regarding clinical papers on ODM or IOFM, please email clinical@deltexmedical.com

A number of Randomised Controlled Trials (RCTs) have been conducted using the ODM to guide fluid management during surgery.

Most recently (March, 2018) British Journal of Anaesthesia published the biggest ever positive study into the use of Deltex’s ODM to guide fluid/drug therapy during anaesthesia. Importantly the paper focuses on major surgery undertaken on patients considered to be at low-moderate haemodynamic risk. It can be found here.

The 420 patient, multicentre, randomised, controlled, researcher-blinded study is titled: Effect of goal-directed haemodynamic therapy on postoperative complications in low–moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial), J.M. Calvo-Vecino, J. Ripollés-Melchor, M.G. Mythen, R. Casans-Francés, A. Balik, J.P. Artacho, E. Martínez-Hurtado, A. Serrano Romero, C. Fernández Pérez , S. Asuero de Lis

The discussion points out that “A haemodynamic optimization algorithm for management of low-moderate risk patients having major abdominal surgery significantly reduced postoperative complications in the 180 days after surgery. There was a decrease in AKI, acute respiratory distress syndrome, acute pulmonary oedema, pneumonia, and superficial or deep surgical site infection. LOS was shortened…”

See below for a summary of additional RCTs, or the Bibliography for a list of references.

St Thomas’ RCT, July 2016

Summary
  • Length of Stay significantly shorter in ODM patients (6 vs. 8 days; p=0.01).
  • Compared to ODM, LiDCOrapid has poor sensitivity and wide limits of agreement
  • Significantly more LiDCOrapid patients treated with vasopressors (56% vs. 33%, p=0.01).
  • ODM patients mobilised one day before LiDCOrapid ones (p=0.038).
  • ODM and LiDCOrapid are not interchangeable.
Method

Results from a 127 patients, single-centre, patient-blinded, randomised controlled trial for elective colorectal surgery within an enhanced recovery programme, were presented on 6th July 2016 at ACPGBI. Patients received simultaneous monitoring using oesphageal Doppler (ODM) and LiDCOrapid when undergoing both open and laparoscopic surgery. Following randomisation, anaesthetists used one monitor to guide fluid management whilst blinded to the other monitor.

Outcomes

The sensitivity of the LiDCOrapid device was 62%. The limits of agreement between the two monitors were -50% to 54% for percentage change in Stroke Volume (SV). There was no change in observed equivalence between the technologies when readings during vasopressor use or pneumoperitoneum were excluded. 

The significant reduction in length of stay in ODM patients is consistent with the results of a meta-analysis of IOFM outcome benefit.   Link   

Conclusion

The authors concluded:

“Marked disagreement was observed in GDFT guided by LiDCOrapid versus ODM in colorectal ERP patients. Length of stay may be prolonged in the LiDCOrapid group”.

 

Spanish RCT, May 2016

Summary
  • 72% reduction in total number of complications from 198 to 56 (p<0.01)
  • 45% reduction in number of patients suffering one or more complications, meaning Doppler use saved 28 additional patients from suffering any complication (15% v 28%: p<0.01)
  • 2 day reduction in median length of stay (p<0.01)
Method

Results from a 450 patient Spanish Government funded multi-centre RCT were presented at Euroanaesthesia 2016. Patients undergoing major gastrointestinal, urological, gynaecological and orthopaedic surgery were managed using oesophageal Doppler to maintain an optimal Stroke Volume (SV), Mean Arterial Pressure (MAP) >70mmHg and Cardiac Index (CI) ≥2.5l/min/m2, when compared to conventional care.

Outcome

This is the largest ever intra-operative fluid management RCT and the 12th RCT to show substantial improvements in patient outcomes from use of the 10% Stroke Volume Optimization algorithm guided by oesophageal Doppler.

 

ODM has since been recommended as the preferred monitor for use within the Spanish National Enhanced Recovery guidelines.

Conclusion

The authors concluded:

Fluid management using ODM guided SV, CI and MAP as “the key parameters, leads to a decrease in postoperative complications in patients undergoing major surgery”.

Oesophageal Doppler Monitoring has gained support from a number of clinical and regulatory bodies, both within the UK and internationally. Robust evidence demonstrates reduced post-operative complications and hospital length of stay.

NICE
March 2011 saw the publication of the NICE Medical Technology Guidance for CardioQ-ODM Oesophageal Doppler Monitor (MTG3). The recommendation is specifically for the use of the CardioQ-ODM Oesophageal Doppler Monitor to guide fluid optimisation during surgery in over 800,000 procedures in England annually. The CardioQ-ODM is the only technology with sufficient evidence-base to support such extensive recommendation and guidance. Read More

GIFTASUP
The British Consensus Guidelines on Intravenous Therapy for Adult Surgery (GIFTASUP) were released in 2008, for dissemination to members of participating professional bodies. GIFTASUP states that a response in SV should be assessed using flow-based technology, intraoperative treatment can reduce complication rates and length of hospital stay and that postoperative monitoring should be carried out in non-elective abdominal and orthopaedic surgery. Read More

NTAC
The NHS Technology Adoption Centre (NTAC) conducted an audit in over 1300 patients, undergoing a range of surgical procedures in three NHS hospitals. Following the comprehensive evidence from the RCTs, NTAC wanted to determine whether clinicians could be trained to use ODM in ‘real world’ hospital settings and gain the same benefits observed in the tightly controlled clinical studies. Read More

SFAR
The Société Francais d’Anesthésie et de Réanimation (SFAR) have recently released a set of guidelines entitled ‘Stratégie du remplissage vasculaire périopératoire’ (Guidelines for perioperative haemodynamic optimisation), which are SFAR Board approved. The objective is to ‘highlight perioperative vascular filling practices (VF) as a benefit for patients, for use in daily practice’. The first three recommendations relate directly to ODM and Fluid Management and received the highest possible rating of GRADE1+. Read More

 

ODM guided fluid management is one of six High Impact Innovations listed in the UK NHS 2011 Innovation Health & Wealth report. Based on comprehensive evidence, the document is subtitled Accelerating Adoption and Diffusion in the NHS.

It “sets out an integrated set of measures that together will support the adoption and diffusion of innovation across the NHS.”

It also “sets a delivery agenda that will significantly ramp up the pace and scale of change and innovation.”

In labelling Deltex’s ODM as a High Impact Innovation, the report talks of its comprehensive evidence base and the NICE forecast that ODM guided fluid management has the potential to benefit 800,000 surgical patients by reducing postoperative complications and consequent length of hospital stay.