A comparison of the ability of the Inditherm® mattress and the forced hot air blower to prevent hypothermia
| ISRCTN | ISRCTN38219428 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38219428 | 
| Secondary identifying numbers | N0256171924 | 
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 09/07/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
        
            
            Record updated in last year
        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Dr Susan Mallett
Scientific
                                        Scientific
                                                Department of Anaesthesia
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
                                                
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Hospital | 
| Study type | Prevention | 
| Scientific title | |
| Study objectives | Is the under-patient warming-mattress as, more or less effective than the forced hot air blower in preventing hypothermia in patients having major abdominal surgery? | 
| Ethics approval(s) | Not provided at time of registration | 
| Health condition(s) or problem(s) studied | Surgery: Pancreatectomy | 
| Intervention | Patients will be randomly allocated to mattress or forced air warming. Temperatures will be monitored before, during and after the operation. The results will be compared and analysed. | 
| Intervention type | Procedure/Surgery | 
| Primary outcome measure | To establish whether body temperature is maintained to the same extent with the Inditherm® mattress as with the forced hot air blower. | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 01/01/2005 | 
| Completion date | 05/12/2005 | 
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Not Specified | 
| Sex | Not Specified | 
| Target number of participants | 60 | 
| Key inclusion criteria | 60 patients scheduled for pancreatectomy or liver resection | 
| Key exclusion criteria | Patients do no consent. | 
| Date of first enrolment | 01/01/2005 | 
| Date of final enrolment | 05/12/2005 | 
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
                                            Department of Anaesthesia
                                        
                                        
                                            
                                            London
NW3 2QG
United Kingdom
                                    NW3 2QG
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
Hospital/treatment centre
                                                The Royal Free Hampstead 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 | 

