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 |
| Secondary identifying numbers | N0159166708 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 23/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David J Leaper
Scientific
Scientific
C/o Dr EA Baker, Professorial Unit of Surgery
University Hospital of North Tees
Stockton-on-Tees
TS19 8PE
United Kingdom
Study information
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 23/05/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
C/o Dr EA Baker, Professorial Unit of Surgery
Stockton-on-Tees
TS19 8PE
United Kingdom
TS19 8PE
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
North Tees and Hartlepool NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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 | 01/04/2007 | Yes | No |
