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

June 11, 2014 updated by: Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust

A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital, BSUH NHS Trust

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:

  • 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

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
Experimental: warming mattress
Patient warmed with electric mattress
Other: warming mattress
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
Other Names:
  • Inditherm electric carbon polymer warming mattress
Active Comparator: warming blanket
Forced air warming blanket
Other: warming blanket
Other Names:
  • forced-air warming blanket
  • Bair hugger

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
15minutes to 2 hours approximately postoperatively in recovery room

Secondary Outcome Measures

Outcome Measure
Time Frame
shivering
Time Frame: up to 2h post op (time in recovery)
up to 2h post op (time in recovery)
Core temperature
Time Frame: From induction of anaesthesia to arrival in recovery
From induction of anaesthesia to arrival in recovery

Collaborators and Investigators

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

Sponsor

Brighton and Sussex University Hospitals NHS Trust

Investigators

  • Principal Investigator: Christopher M Harper, MBBS FRCA, BSUH

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

February 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 27, 2010

Study Record Updates

Last Update Posted (Estimate)

June 12, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/183/HAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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