Surgical Outcome and Multimodal Monitoring - SOMM

NCT02293473 | Completed

• 1 other identifier: SOMM
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test if measuring the depth of anaesthesia, brain tissue oxygenation and haemodynamic parameters and specially designed interventions according to the measurements can improve the outcome of high risk surgical patients undergoing major abdominal surgery.

Conditions

Complications

Outcome Measures

Primary Outcomes (1)

• Reduced hospital stay

  We are trying to prove that the protocol group will have a reduced hospital stay of 2 days

  after release from hospital, an expected average of 10 days after surgery

Study Arms (2)

Protocol Group

EXPERIMENTAL

Using multimodal monitoring to optimise the patients' haemodynamic status, namely, the use of LiDCO Rapid, BIS-Bispectral Index Monitor and INVOS-Cerebral Oxygenation Monitor monitors to assess and "fine tune" the patient, as described in the study protocol in detail.

Device: LiDCO Rapid; Device: BIS-Bispectral Index Monitor; Device: INVOS-Cerebral Oxygenation Monitor

Control Group

ACTIVE COMPARATOR

Using current standard of care

Other: Standard of care

Interventions

LiDCO Rapid DEVICE

LiDCO Rapid haemodynamic monitor

Protocol Group

BIS-Bispectral Index Monitor DEVICE

Depth of anaesthesia

Protocol Group

INVOS-Cerebral Oxygenation Monitor DEVICE

regional brain tissue oxygenation

Protocol Group

Standard of care OTHER

Using standard of care

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stomach surgery
• Pancreas surgery
• Large intestinal resections
• High risk surgical patients (ASA /American Society of Anesthesiologists/ 2-3 )

You may not qualify if:

• Pregnant women
• Laparoscopic surgery
• Palliative procedures

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (16)

• Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

  PMID: 18582931 BACKGROUND

• Findlay G, Goodwin A, Protopappa K, Smith N, Mason M. Knowing the risk: a review of the peri-operative care of surgical patients. London: National confidental enquiry into patient outcome and death (NCEPOD); 2011

  BACKGROUND

• Story DA, Leslie K, Myles PS, Fink M, Poustie SJ, Forbes A, Yap S, Beavis V, Kerridge R; REASON Investigators, Australian and New Zealand College of Anaesthetists Trials Group. Complications and mortality in older surgical patients in Australia and New Zealand (the REASON study): a multicentre, prospective, observational study. Anaesthesia. 2010 Oct;65(10):1022-30. doi: 10.1111/j.1365-2044.2010.06478.x.

  PMID: 20731639 BACKGROUND

• Quality and Performance in the NHS: NHS Performance Indicators London: NHS Executive; 2000

  BACKGROUND

• Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

  PMID: 15616043 BACKGROUND

• Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

  PMID: 22998715 BACKGROUND

• Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, Kurz A, Greenwald S. Hospital stay and mortality are increased in patients having a "triple low" of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012 Jun;116(6):1195-203. doi: 10.1097/ALN.0b013e31825683dc.

  PMID: 22546967 BACKGROUND

• Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.

  PMID: 16356219 BACKGROUND

• Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988 Dec;94(6):1176-86. doi: 10.1378/chest.94.6.1176.

  PMID: 3191758 BACKGROUND

• Green D, Paklet L. Latest developments in peri-operative monitoring of the high-risk major surgery patient. Int J Surg. 2010;8(2):90-9. doi: 10.1016/j.ijsu.2009.12.004. Epub 2010 Jan 14.

  PMID: 20079469 BACKGROUND

• Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, McManus E. Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999 Apr 24;318(7191):1099-103. doi: 10.1136/bmj.318.7191.1099.

  PMID: 10213716 BACKGROUND

• Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M; Canadian Critical Care Clinical Trials Group. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14. doi: 10.1056/NEJMoa021108.

  PMID: 12510037 BACKGROUND

• Walsh SR, Tang T, Bass S, Gaunt ME. Doppler-guided intra-operative fluid management during major abdominal surgery: systematic review and meta-analysis. Int J Clin Pract. 2008 Mar;62(3):466-70. doi: 10.1111/j.1742-1241.2007.01516.x. Epub 2007 Nov 21.

  PMID: 18031528 BACKGROUND

• Abbas SM, Hill AG. Systematic review of the literature for the use of oesophageal Doppler monitor for fluid replacement in major abdominal surgery. Anaesthesia. 2008 Jan;63(1):44-51. doi: 10.1111/j.1365-2044.2007.05233.x.

  PMID: 18086070 BACKGROUND

• Gurgel ST, do Nascimento P Jr. Maintaining tissue perfusion in high-risk surgical patients: a systematic review of randomized clinical trials. Anesth Analg. 2011 Jun;112(6):1384-91. doi: 10.1213/ANE.0b013e3182055384. Epub 2010 Dec 14.

  PMID: 21156979 BACKGROUND

• Jenko M, Jerin A, Spindler Vesel A. Biomarkers of neuroinflammation in abdominal cancer surgery with optimised anaesthesia. Acta Chim Slov. 2025 Jan 4;72(1):45-51. doi: 10.17344/acsi.2024.8901.

  PMID: 40109058 DERIVED

Related Links

• Collaborator

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Vesna Novak Jankovic, MD, PhD

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. Vesna Novak Jankovic, MD, PhD

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: November 18, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: April 10, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

SL (1)