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

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bair Paws Patient Adjustable Warming System
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring hypothermia, surgical site infection, opioid usage, blood loss, pain severity, anxiety, Length of Stay

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Columbian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Bair PawsPatient Adjustable Warming System

Passive pre-warming

Arm Description

Bair PawsPatient Adjustable Warming System for active pre-warming

Passive pre-warming

Outcomes

Primary Outcome Measures

Duration of hypothermia
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.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2014
Last Updated
August 30, 2016
Sponsor
3M
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1. Study Identification

Unique Protocol Identification Number
NCT02177903
Brief Title
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
Official Title
Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
hypothermia, surgical site infection, opioid usage, blood loss, pain severity, anxiety, Length of Stay

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bair PawsPatient Adjustable Warming System
Arm Type
Other
Arm Description
Bair PawsPatient Adjustable Warming System for active pre-warming
Arm Title
Passive pre-warming
Arm Type
Other
Arm Description
Passive pre-warming
Intervention Type
Device
Intervention Name(s)
Bair Paws Patient Adjustable Warming System
Other Intervention Name(s)
Bair Paws Flex Gown
Intervention Description
Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
Primary Outcome Measure Information:
Title
Duration of hypothermia
Description
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.
Time Frame
Up to 12 hours, until PACU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Merchant, MD
Organizational Affiliation
Staff Anesthesiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29872966
Citation
Lau A, Lowlaavar N, Cooke EM, West N, German A, Morse DJ, Gorges M, Merchant RN. Effect of preoperative warming on intraoperative hypothermia: a randomized-controlled trial. Can J Anaesth. 2018 Sep;65(9):1029-1040. doi: 10.1007/s12630-018-1161-8. Epub 2018 Jun 5.
Results Reference
derived

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

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