Warming Mattress Trial
This study is currently recruiting participants.
Verified June 2011 by Brighton and Sussex University Hospitals NHS Trust
Sponsor:
Brighton and Sussex University Hospitals NHS Trust
Information provided by:
Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01056991
First received: January 25, 2010
Last updated: June 17, 2011
Last verified: June 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 25, 2010 | ||||
| Last Updated Date | June 17, 2011 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Post-operative core temperature greater than or equal to 36 degrees centigrade. This is a surrogate marker for complications such as reduced wound infection and reduced hospital stay that have been previously established by other research. [ Time Frame: 15minutes to 2 hours approximately postoperatively in recovery room ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01056991 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Warming Mattress Trial | ||||
| Official Title ICMJE | A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia | ||||
| Brief Summary | This study will determine if modern under-patient warming mattresses are as effective as forced air warming blankets in preventing cold and shivering in patients scheduled for non emergency surgery. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | |||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Hypothermia | ||||
| Intervention ICMJE | Other: Under patient warming mattress
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia |
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| Study Arm (s) |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01056991 | ||||
| Other Study ID Numbers ICMJE | 09/183/HAR | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | Dr Christopher M Harper, Brighton and Sussex University Hospitals NHS Trust | ||||
| Study Sponsor ICMJE | Brighton and Sussex University Hospitals NHS Trust | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | Brighton and Sussex University Hospitals NHS Trust | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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