Condition category
Signs and Symptoms
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
11/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hypothermia occurs when body temperature drops below 35C (95F). Preventing hypothermia during surgery is beneficial for patients and there are many devices available to keep patients warm. The most commonly used warming device is the forced air warmer, which blows warm air through a special single-use blanket. However, this warming set up can interfere with the surgical field and has inherent cumulative costs. The aim of this study is to determine whether heating patients using a reusable resistive heated mattress is as effective as the more commonly used forced air warming blanket.

Who can participate?
Adult patients undergoing elective surgery

What does the study involve?
Participants are randomly allocated to be kept warm with either a forced air warming blanket or a resistive heating mattress when they were asleep. Both devices are already available and used routinely at our hospital. The participants’ temperature is measured in the anaesthetic room, during the operation and at the end of surgery to allow us to assess which warming device was most effective.

What are the possible benefits and risks of participating?
The potential benefits include the ability to warm patients earlier in the resistive heating mattress group (since there was no requirement to apply a blanket and wait for surgical draping) and more intense temperature monitoring during the operation for both groups. The patients receiving resistive heating warming may also have had a reduced risk of developing pressure ulcers since there is some evidence suggesting favourable pressure-relieving properties of this mattress. It is however important to note that all patients who were deemed suitable for the study would have received warming and temperature monitoring regardless of whether they enrolled in the study or not. The risks of using any cutaneous warming device is that of burns. The forced air-warming may also affect theatre convection currents which can adversely influence the infection risk of patients receiving anaesthetics, particularly in laminar flow theatres. With any electrical device there is also potential for exposure to electrical leakage currents.

Where is the study run from?
Brighton & Sussex University Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
August 2005 to February 2013

Who is funding the study?
Brighton and Sussex University Hospitals NHS Trust (UK)

Who is the main contact?
Dr C Mark Harper
Mark.Harper@doctors.org.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr C Mark Harper

ORCID ID

Contact details

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 609060
Mark.Harper@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01056991

Protocol/serial number

N0051166184

Study information

Scientific title

Are modern under-patient warming blankets as effective as forced-air warming blankets in preventing peri-operative hypothermia?

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Pilot randomised comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Signs and Symptoms: Peri-operative hypothermia

Intervention

This is intended to be a pilot randomised comparative study which will probably show equivalence and will allow power calculation for future randomised controlled trial which could prove a statistically significant difference if one exists.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Post-operative core temperature being greater than or equal to 36 degrees Celcius.

Secondary outcome measures

Intra-operative blood loss

Overall trial start date

18/08/2005

Overall trial end date

01/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

100 surgical patients being operated on in the supine position.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

18/08/2005

Recruitment end date

01/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Sussex County Hospital
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Brighton and Sussex University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26787794

Publication citations

Additional files

Editorial Notes

On 11/04/2016 the following changes were made to the trial record: 1. Plain English summary added. 2. Publication reference added. 3. The overall trial end date was changed from 01/12/2005 to 01/02/2013.