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ISRCTN
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ISRCTN66744664
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0159166708
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Pilot randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Injury, Occupational Diseases, Poisoning: Fractured neck of femur
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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).
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Anticipated start date
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23/05/2005
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Anticipated end date
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30/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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150
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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North Tees and Hartlepool NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Prof
David J
Leaper
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Address
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C/o Dr EA Baker, Professorial Unit of Surgery
University Hospital of North Tees
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City/town
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Stockton-on-Tees
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Zip/Postcode
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TS19 8PE
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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15/07/2009
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Date ISRCTN assigned
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29/09/2006
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