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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177903
• Other study ID #: EM-05-013093
• Status: Completed
• Phase: N/A
• First received: June 25, 2014
• Last updated: August 30, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

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.

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 hours, until PACU discharge	Yes