Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
23/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David J Leaper

ORCID ID

Contact details

C/o Dr EA Baker
Professorial Unit of Surgery
University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0159166708

Study information

Scientific title

Acronym

Study hypothesis

The proposed study aims to investigate the value of warming during the initial hospital phase of three groups of patients (A&E patients, elderly fallers and those with abdominal pain or suspected fractured neck of femur). The warming will take place from the time of admission for 4 hours or until discharge whichever comes first. We will use clinical variables to assess various clinical outcomes.

Ethics approval

Not provided at time of registration

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Injury, Occupational Diseases, Poisoning: Fractured neck of femur

Intervention

Avoidance of hypothermia in the peri-operative period has convincingly shown to reduce mortality and morbidity especially infectious complications. In this proposed randomised controlled trial, patients will be randomised into two groups on admission:
1. The intervention group will receive systematic warming.
2. The control group will not receive warming but will receive standard care currently provided by the hospital.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Core temperature on leaving the A&E / post warming
2. Pain scores on leaving A&E / post warming
3. Thermal comfort scores on leaving A&E / post warming

Secondary outcome measures

Not provided at time of registration

Overall trial start date

23/05/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

150 patients in total, 50 for each group from:
1. Adult patients presenting to A&E/Emergency Assessment Unit
2. Elderly fallers (over 65 yrs)
3. Adults with abdominal pain or suspected fractured neck of femur

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

150

Participant exclusion criteria

1. Patients with suspected acute coronary syndromes or in cardiac arrest
2. Patients who would normally be transported on a spine board
3. Patients suffering from dementia
4. Patients with pyrexia (>39 degree Celsius).

Recruitment start date

23/05/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

C/o Dr EA Baker, Professorial Unit of Surgery
Stockton-on-Tees
TS19 8PE
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

North Tees and Hartlepool NHS Trust (UK), NHS R&D Support Funding

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

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17380549

Publication citations

  1. Results

    Wong PF, Kumar S, Bohra A, Whetter D, Leaper DJ, Randomized clinical trial of perioperative systemic warming in major elective abdominal surgery., Br J Surg, 2007, 94, 4, 421-426, doi: 10.1002/bjs.5631.

Additional files

Editorial Notes