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

ISRCTN	ISRCTN31681970
DOI	https://doi.org/10.1186/ISRCTN31681970
ClinicalTrials.gov number	NCT01056991
Secondary identifying numbers	N0051166184

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 11/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr C Mark Harper
Scientific

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Phone	+44 (0)1273 609060
Email	Mark.Harper@doctors.org.uk

Study information

Study design	Pilot randomised comparative study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title	Are modern under-patient warming blankets as effective as forced-air warming blankets in preventing peri-operative hypothermia?
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Post-operative core temperature being greater than or equal to 36 degrees Celcius.
Secondary outcome measures	Intra-operative blood loss
Overall study start date	18/08/2005
Completion date	01/02/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Key inclusion criteria	100 surgical patients being operated on in the supine position.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	18/08/2005
Date of final enrolment	01/02/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Sussex County Hospital

Brighton
BN2 5BE
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Brighton and Sussex University Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2016		Yes	No

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.