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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypothermia |
Other: Under patient warming mattress |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia |
Resource links provided by NLM:
Further study details as provided by Brighton and Sussex University Hospitals NHS Trust:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: warming mattress |
Other: Under patient warming mattress
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
|
|
Active Comparator: Warming blanket
Forced air warming blanket
|
Other: Under patient warming mattress
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All patients undergoing elective (non emergency) surgery who will require intra-operative warming
- Patients whose surgery will be performed with them in the supine position
Exclusion Criteria:
- Abdominal aortic aneurysm repair
- All adults (over 18 years) who refuse,who are unable to fully understand the trial
- ALL laparoscopic surgeries
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056991
Contacts
| Contact: Christopher M Harper, Bsc MBBS FRCA | 01273696955 | mark.harper@doctors.org.uk |
Locations
| United Kingdom | |
| Royal Sussex County Hospital, BSUH NHS Trust | Recruiting |
| Brighton, United Kingdom, BN2 5BE | |
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
More Information
No publications provided
| Responsible Party: | Dr Christopher M Harper, Brighton and Sussex University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01056991 History of Changes |
| Other Study ID Numbers: | 09/183/HAR |
| Study First Received: | January 25, 2010 |
| Last Updated: | June 17, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Hypothermia Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013