Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes

September 30, 2024 updated by: Solventum US LLC

Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes

The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.

Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:

  • Increased comfort in the pre-operative period by being warmer
  • Decreased incidence of mild hypothermia
  • Possible decreased incidence of transfusion with less bleeding
  • Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)
  • Possible shorter stay in the PACU and overall Length of Stay (LOS)
  • Possible decreased risk for surgical site infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elective or "urgent" surgery under general anesthesia
  • ≥19 years but ≤85 years of age
  • Able to provide informed consent.

Exclusion Criteria:

  • Refusal of Informed consent
  • Metabolic derangement/drug therapy already affecting thermal homeostasis
  • Preexisting hypothermia (<35.5 degreeC) or hyperthermia (>37.5 degreeC) (oral)
  • Surgical procedure anticipated to be longer than 6 hours or less than 1 hour
  • Emergency (category 1a) Surgery
  • Patients undergoing exclusively spinal or epidural anesthesia
  • Patients receiving aortic cross-clamping
  • Patients receiving transdermal medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bair PawsPatient Adjustable Warming System
Bair PawsPatient Adjustable Warming System for active pre-warming
Device: Bair Paws Patient Adjustable Warming System
Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
Other Names:
  • Bair Paws Flex Gown
Other: Passive pre-warming
Device: Bair Paws Patient Adjustable Warming System
Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
Other Names:
  • Bair Paws Flex Gown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hypothermia
Time Frame: Up to 12 hours, until PACU discharge
The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge.
Up to 12 hours, until PACU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solventum US LLC

Collaborators

3M

Investigators

  • Principal Investigator: Richard Merchant, MD, Staff Anesthesiologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimated)

June 30, 2014

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EM-05-013093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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