Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01056991
First received: January 25, 2010
Last updated: June 11, 2014
Last verified: June 2014
  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
Inadvertent Perioperative Hypothermia
Patient Warming
Other: warming mattress
Other: warming blanket

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ]

Secondary Outcome Measures:
  • shivering [ Time Frame: up to 2h post op (time in recovery) ] [ Designated as safety issue: No ]
  • Core temperature [ Time Frame: From induction of anaesthesia to arrival in recovery ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: February 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: warming mattress
Patient warmed with electric mattress
Other: warming mattress
comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia
Other Name: Inditherm electric carbon polymer warming mattress
Active Comparator: warming blanket
Forced air warming blanket
Other: warming blanket
Other Names:
  • forced-air warming blanket
  • Bair hugger

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056991

Locations
United Kingdom
Royal Sussex County Hospital, BSUH NHS Trust
Brighton, United Kingdom, BN2 5BE
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
Investigators
Principal Investigator: Christopher M Harper, MBBS FRCA BSUH
  More Information

No publications provided

Responsible Party: Dr C. Mark Harper, Consultant Anaesthetist, 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 11, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014