Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models

December 20, 2019 updated by: Nelson Wolosker
Prospective randomized trial comparing effectiveness of two different forced-air warming blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal aortic aneurysm repair (EVAR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty patients undergoing LEA and EVAR will be randomized into two groups: Group upper body blanket and Group underbody blanket. All patients will receive general anesthesia and body temperature will be measured and registered by an esophageal thermometer with 15 minutes interval beginning immediately after tracheal intubation up to tracheal extubation. The warming unit used (Bair Hugger 750 warming unit, Arizant Healthcare) will be the same for both groups and the blankets tested will be: upper body blanket (Bair Hugger 522 upper body blanket, 3M) and underbody blanket (Bair Hugger 635 full acess underbody blanket, 3M). Surgical and anesthetic complications will be noted. Only surgeries with minimum 45 minutes duration will be accepted for the purposes of this study.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing LEA and EVAR
  • American Society of Anesthesiologists physical status (ASA) : 1-4

Exclusion Criteria:

  • Non-endovascular surgery
  • pregnant patients
  • patient refusal
  • less than 45 minutes duration of surgery

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Upper body blanket, Bair Hugger
Patients undergoing EVAR and LEA will use this type of warming blanket.
Device: Upper body blanket, Bair Hugger
Upper body warming blanket will be used in patients undergoing LEA and EVAR.
Other: Underbody blanket, Bair Hugger
Patients undergoing EVAR and LEA will use this type of warming blanket.
Device: Underbody blanket, Bair Hugger
Underbody warming blanket will be used in patients undergoing LEA and EVAR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.
Time Frame: Across duration of surgery (up to 210 minutes)
After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.
Across duration of surgery (up to 210 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age ( in Years)
Time Frame: At time of surgery ( in minutes)
The investigators will observe the profile of the patients and the mean of age in two groups.
At time of surgery ( in minutes)
Gender
Time Frame: At time of surgery ( in minutes)
The investigators will observe gender distribution in the two groups studied.
At time of surgery ( in minutes)
Type of Surgery ( LEA and EVAR )
Time Frame: At time of surgery ( in minutes)
The investigators will observe the type of surgery distribution profile in the two groups studied.
At time of surgery ( in minutes)
Duration of Surgery ( in Minutes)
Time Frame: Across duration of surgery ( in minutes)
The investigators will observe the duration of surgery (in minutes) in the two groups studied.
Across duration of surgery ( in minutes)

Collaborators and Investigators

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

Sponsor

Nelson Wolosker

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)

June 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Forced-air warming in ES

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.

Clinical Trials on Hypothermia

Clinical Trials on Upper body blanket, Bair Hugger

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe