Clinical trial NCT03861026: Cerebral Oximetry to Reduce Organ Dysfunction After Non-cardiac Surgery
Official title: Role of Cerebral Oximetry In Reducing Postoperative End Organ Dysfunction/Failure After Complex Non- Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Desaturation
Surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 101
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, controlled clinical trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The investigator will collect delirium, stroke, transient ischemic attacks, myocardial infarction (troponin essays), pulmonary embolism (clinical, echocardiography and computer tomography assessments), renal failure (creatinine increase by at least 50% from baseline), pneumonia (clinical, X-ray), atrial fibrillation (documented electrocardiogram), bleeding requiring a transfusion of more than or equal to 4 units of red blood cells within 72 hours of surgery, mechanical ventilation for 2 days, major wound disruption, surgical site infection, sepsis, septic shock, systemic inflammatory response syndrome (vasoactive medication requirement), unplanned return to the operating room, and vascular graft failure, for the duration of hospital stay, as well as, all-cause 30-day mortality. 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 (administer WHODAS).

Eligibility criteria: Inclusion Criteria:

* Patients \> 60 years of age
* Undergoing elective major non-cardiac surgery with an anticipated surgical duration of 4 hours or more,
* Preoperative written informed consent.

Exclusion Criteria:

* Emergency surgery
* Laparoscopic/Robotic surgery

Primary outcomes:
measure: A composite outcome of major end organ dysfunction
timeFrame: surgery date to 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Tornoto General Hospital, University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital, Univerity health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: George Djaiani
role: PRINCIPAL_INVESTIGATOR
References: