Role of Cerebral Oximetry in Reducing Postoperative End Organ Dysfunction/Failure After Complex Non-Cardiac Surgery

NCT04627506 | Unknown

• 1 other identifier: 2019/00827
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The number of elderly patients requiring general anesthesia for major surgical procedures is increasing dramatically. It is estimated that 20% of these patients will develop major complications after surgery. Monitoring brain oxygen saturation may be helpful in reducing the postoperative complication rates. A decrease in brain oxygen is a sign that all other vital organs such as kidneys, heart, liver, and intestines have reduced blood supply and are starved from oxygen. This happens in 1 out of 5 patients undergoing major complex surgeries. Brain oxygen saturation monitor at this time is not used routinely during surgery, primarily due to the added cost, as well as, insufficient evidence that restoring the brain oxygen saturation to baseline would result in better outcomes. Patients will be randomly assigned to either study or control groups. In the study group, a special algorithm will be used to restore brain oxygen saturation. In the control group, the brain oxygen saturation will be monitored continuously, but the monitor screen will be electronically blinded, and standard clinical care applied. The objective of this study is to see if restoring the brain oxygen saturation to baseline results in less complication rates after surgery. The objective of this study is to reduce the incidence of postoperative morbidity due to end organ dysfunction after major non-cardiac surgery in elderly patients. The primary aim is to determine if restoration of rSO2 to baseline levels results in reduced incidence of major organ morbidity and mortality (MOMM). A secondary aim is to determine a cost-effectiveness of this monitoring modality.

Conditions

Surgery

Keywords

Cerebral Desaturation

Outcome Measures

Primary Outcomes (1)

• A composite outcome of major end organ dysfunction

  A composite outcome will be assessed as a dichotomous outcome. (YES or NO). All components of the composite outcome will be weighted equally. They will include the following outcomes: postoperative delirium assessed with Confusion Assessment Method (CAM), Stroke assessed clinically, Transient Ischemic Attacks assessed clinically, Myocardial infarction, Pulmonary Embolism, Renal failure, Pneumonia, Atrial fibrillation, bleeding, mechanical ventilation for ≥48 hours, Major wound disruption, Surgical site infection, Sepsis, Septic shock, Systemic inflammatory response syndrome, Vascular graft failure. Frailty scale \& DASI questionnaires will be administered at screening visit. Postoperative quality of recovery score (QoR-15) with be performed at baseline, POD 1 \& 5 (discharge if earlier)\]. Disability Free Survival (DFS) at 6 months (WHODAS).

  Surgery through to 6 months postoperatively

Study Arms (2)

Control Group

NO INTERVENTION

Bilateral NIRS will be used to measure rSO2 intraoperatively. In the control group, the cerebral oximetry monitor screen will be concealed, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in cerebral oximetry application and unaware of the study design. Standardized anesthesia and surgical management will be conducted according to routine institutional practice.

Study Group

EXPERIMENTAL

Bilateral NIRS will be used to measure rSO2 intraoperatively. In the interventional group, an alarm threshold at 90% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 90% of the baseline measurements. The intervention will be commenced within 15 seconds of the reduction in rSO2 value.

Device: Bilateral NIRS (Masimo, O3TM Regional Oximetry)

Interventions

Bilateral NIRS (Masimo, O3TM Regional Oximetry) DEVICE

Bilateral NIRS will be used to measure rSO2 intraoperatively. The NIRS electrodes will be placed on fronto-temporal area and baseline values of rSO2 obtained according to manufacturer's guidelines in the operating room prior to induction of anesthesia. The NIRS screen will be concealed in the control group to ensure blinding.

Study Group

Eligibility Criteria

• Age: 61 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 60 years old
• Undergoing elective major non-cardiac surgery with predicted surgery length of 3 hours
• Signed informed consent

You may not qualify if:

• Emergency surgeries
• Laparoscopic / robotic surgeries
• Pregnant women

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (12)

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  PMID: 20731639 BACKGROUND

• Casati A, Spreafico E, Putzu M, Fanelli G. New technology for noninvasive brain monitoring: continuous cerebral oximetry. Minerva Anestesiol. 2006 Jul-Aug;72(7-8):605-25. English, Italian.

  PMID: 16865080 BACKGROUND

• Scott JP, Hoffman GM. Near-infrared spectroscopy: exposing the dark (venous) side of the circulation. Paediatr Anaesth. 2014 Jan;24(1):74-88. doi: 10.1111/pan.12301. Epub 2013 Nov 23.

  PMID: 24267637 BACKGROUND

• Meng L, Cannesson M, Alexander BS, Yu Z, Kain ZN, Cerussi AE, Tromberg BJ, Mantulin WW. Effect of phenylephrine and ephedrine bolus treatment on cerebral oxygenation in anaesthetized patients. Br J Anaesth. 2011 Aug;107(2):209-17. doi: 10.1093/bja/aer150. Epub 2011 Jun 3.

  PMID: 21642644 BACKGROUND

• Paarmann H, Heringlake M, Heinze H, Hanke T, Sier H, Karsten J, Schon J. Non-invasive cerebral oxygenation reflects mixed venous oxygen saturation during the varying haemodynamic conditions in patients undergoing transapical transcatheter aortic valve implantation. Interact Cardiovasc Thorac Surg. 2012 Mar;14(3):268-72. doi: 10.1093/icvts/ivr102. Epub 2011 Dec 7.

  PMID: 22159266 BACKGROUND

• Green DW. A retrospective study of changes in cerebral oxygenation using a cerebral oximeter in older patients undergoing prolonged major abdominal surgery. Eur J Anaesthesiol. 2007 Mar;24(3):230-4. doi: 10.1017/S0265021506001645. Epub 2006 Oct 23.

  PMID: 17054814 BACKGROUND

• Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. doi: 10.1053/j.jvca.2004.07.007.

  PMID: 15578464 BACKGROUND

• Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.

  PMID: 19101265 BACKGROUND

• Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surg Forum. 2004;7(5):E376-81. doi: 10.1532/HSF98.20041062.

  PMID: 15799908 BACKGROUND

• Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.

  PMID: 17179242 BACKGROUND

• Heringlake M, Garbers C, Kabler JH, Anderson I, Heinze H, Schon J, Berger KU, Dibbelt L, Sievers HH, Hanke T. Preoperative cerebral oxygen saturation and clinical outcomes in cardiac surgery. Anesthesiology. 2011 Jan;114(1):58-69. doi: 10.1097/ALN.0b013e3181fef34e.

  PMID: 21178669 BACKGROUND

• Schoen J, Meyerrose J, Paarmann H, Heringlake M, Hueppe M, Berger KU. Preoperative regional cerebral oxygen saturation is a predictor of postoperative delirium in on-pump cardiac surgery patients: a prospective observational trial. Crit Care. 2011;15(5):R218. doi: 10.1186/cc10454. Epub 2011 Sep 19.

  PMID: 21929765 BACKGROUND

Study Officials

• Lian Kah Ti

  National University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomly allocated to either interventional or control group according to a computer generated randomization code in predetermined size blocks. Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively. The NIRS screen will be concealed in the control group to ensure blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, controlled clinical trial.

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 13, 2020
• Study Start: February 18, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)