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Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket

Primary Purpose

Inadvertent Perioperative Hypothermia, Patient Warming

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
warming mattress
warming blanket
Sponsored by
Brighton and Sussex University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inadvertent Perioperative Hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients undergoing elective (non emergency) surgery who will require intra-operative warming
  • Patients whose surgery will be performed with them in the supine position

Exclusion Criteria:

  • Abdominal aortic aneurysm repair
  • All adults (over 18 years) who refuse,who are unable to fully understand the trial
  • ALL laparoscopic surgeries

Sites / Locations

  • Royal Sussex County Hospital, BSUH NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

warming mattress

warming blanket

Arm Description

Patient warmed with electric mattress

Forced air warming blanket

Outcomes

Primary Outcome Measures

Post-operative core temperature greater than or equal to 36 degrees centigrade. This is a surrogate marker for complications such as reduced wound infection and reduced hospital stay that have been previously established by other research.

Secondary Outcome Measures

shivering
Core temperature

Full Information

First Posted
January 25, 2010
Last Updated
June 11, 2014
Sponsor
Brighton and Sussex University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01056991
Brief Title
Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket
Official Title
A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brighton and Sussex University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will determine if modern under-patient warming mattresses are as effective as forced air warming blankets in preventing cold and shivering in patients scheduled for non emergency surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inadvertent Perioperative Hypothermia, Patient Warming

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
warming mattress
Arm Type
Experimental
Arm Description
Patient warmed with electric mattress
Arm Title
warming blanket
Arm Type
Active Comparator
Arm Description
Forced air warming blanket
Intervention Type
Other
Intervention Name(s)
warming mattress
Other Intervention Name(s)
Inditherm electric carbon polymer warming mattress
Intervention Description
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
Intervention Type
Other
Intervention Name(s)
warming blanket
Other Intervention Name(s)
forced-air warming blanket, Bair hugger
Primary Outcome Measure Information:
Title
Post-operative core temperature greater than or equal to 36 degrees centigrade. This is a surrogate marker for complications such as reduced wound infection and reduced hospital stay that have been previously established by other research.
Time Frame
15minutes to 2 hours approximately postoperatively in recovery room
Secondary Outcome Measure Information:
Title
shivering
Time Frame
up to 2h post op (time in recovery)
Title
Core temperature
Time Frame
From induction of anaesthesia to arrival in recovery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing elective (non emergency) surgery who will require intra-operative warming Patients whose surgery will be performed with them in the supine position Exclusion Criteria: Abdominal aortic aneurysm repair All adults (over 18 years) who refuse,who are unable to fully understand the trial ALL laparoscopic surgeries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Harper, MBBS FRCA
Organizational Affiliation
BSUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Sussex County Hospital, BSUH NHS Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26787794
Citation
John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.
Results Reference
derived

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Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket

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