Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5056 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-27

Study Completion Date

2022-05-17

Brief Summary

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We propose to test the hypothesis that aggressive warming reduces the incidence of major cardiovascular complications, compared to routine care. Half of the participants will be randomly assigned to routine care (core temperature ≈35.5°C), while the other half will receive aggressive warming (\>37°C core temperature) in a multi-center trial.

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Detailed Description

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Hypothermia increases sympathetic activation, promotes tachycardia, and causes hypertension - all of which may increase the risk of myocardial injury. Moderate perioperative hypothermia is now uncommon, but mild hyperthermia (≈35.5°C) remains common. Whether aggressive warming to a truly normothermic level (≈37°C) improves outcomes remains unknown.

Conditions

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Perioperative Care Surgery--Complications Hypothermia; Anesthesia Myocardial Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

To maintain blinding, the anesthesia record will be sealed in an opaque envelope before patients leave the post-anesthesia care unit. The envelope will be marked "Do not open until \[date 35 days after surgery\]." Some hospitals will have electronic records; in those cases, we will ask investigators evaluating postoperative outcomes not to access the anesthesia record.

Study Groups

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Routine thermal management

Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An Multi-Position Upper Body Warming Blanket forced-air cover will be positioned over an appropriate non-operative site, but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further.

Group Type ACTIVE_COMPARATOR

routine thermal management

Intervention Type DEVICE

A forced-air cover will be positioned but will not initially be activated. The warmer will be activated when core temperature decrease to 35.5°C.

Aggressive thermal management

Patients assigned to aggressive warming will be pre-warmed with a full-body Bair Hugger or Bair Paws cover for ≈30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to ≈43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be aggressively warmed during surgery to a target intraoperative core temperature between 37 and 37.5°C, using an Multi-Position Upper Body and Full Access Underbody Warming Blankets forced-air covers when clinically practical. All intravenous fluids will be warmed to body temperature.

Group Type EXPERIMENTAL

aggressive warming

Intervention Type DEVICE

Patients will be pre-warming 30 minutes before induction of anesthesia and aggressively warmed during surgery to a target intraoperative core temperature between 37 and 37.5°C.

Interventions

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aggressive warming

Patients will be pre-warming 30 minutes before induction of anesthesia and aggressively warmed during surgery to a target intraoperative core temperature between 37 and 37.5°C.

Intervention Type DEVICE

routine thermal management

A forced-air cover will be positioned but will not initially be activated. The warmer will be activated when core temperature decrease to 35.5°C.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Scheduled for major noncardiac surgery expected to last 2-6 hours;
* Having general anesthesia;
* Expected to require at least overnight hospitalization;
* Expected to have \>50% of the anterior skin surface available for warming;
* Have at least one of the following risk factors:

a. Age over 65 years; b. History of peripheral vascular surgery; c. History of coronary artery disease; d. History of stroke or transient ischemic attack; e. Serum creatinine \>175 µmal/L (\>2.0 mg/dl); f. Diabetes requiring medication; e. Hypertension requiring medication; g. Current smoking.

Exclusion Criteria

* Have a clinically important coagulopathy in the judgement of the attending anesthesiologist;
* Are septic (clinical diagnosis by the attending anesthesiologist);
* Body mass index exceeding 30 kg/m2;
* End-stage renal disease requiring dialysis;
* Surgeon believes patient to be at particular infection risk.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No