Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket
A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJune 12, 2014
June 1, 2014
3.1 years
January 25, 2010
June 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
15minutes to 2 hours approximately postoperatively in recovery room
Secondary Outcomes (2)
shivering
up to 2h post op (time in recovery)
Core temperature
From induction of anaesthesia to arrival in recovery
Study Arms (2)
warming mattress
EXPERIMENTALPatient warmed with electric mattress
warming blanket
ACTIVE COMPARATORForced air warming blanket
Interventions
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Abdominal aortic aneurysm repair
- All adults (over 18 years) who refuse,who are unable to fully understand the trial
- ALL laparoscopic surgeries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Sussex County Hospital, BSUH NHS Trust
Brighton, BN2 5BE, United Kingdom
Related Publications (1)
John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.
PMID: 26787794DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher M Harper, MBBS FRCA
BSUH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Anaesthetist
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 27, 2010
Study Start
February 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
June 12, 2014
Record last verified: 2014-06