A pilot randomised controlled trial of systemic warming during the initial hospital phase of elderly fallers and patients with abdominal pain or suspected fractured neck of femur

ISRCTN	ISRCTN66744664
DOI	https://doi.org/10.1186/ISRCTN66744664
Protocol serial number	N0159166708
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	North Tees and Hartlepool NHS Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David J Leaper
Scientific

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

Primary study design	Interventional
Study design	Pilot randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	150
Key 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
Key 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).
Date of first enrolment	23/05/2005
Date of final enrolment	30/09/2007

C/o Dr EA Baker, Professorial Unit of Surgery

Stockton-on-Tees
TS19 8PE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes