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

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ClinicalTrials.gov Identifier: NCT01056991
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Inadvertent Perioperative Hypothermia Patient Warming Other: warming mattress Other: warming blanket Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : February 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
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




Primary Outcome Measures :
  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. [ Time Frame: 15minutes to 2 hours approximately postoperatively in recovery room ]

Secondary Outcome Measures :
  1. shivering [ Time Frame: up to 2h post op (time in recovery) ]
  2. Core temperature [ Time Frame: From induction of anaesthesia to arrival in recovery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056991


Locations
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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
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Principal Investigator: Christopher M Harper, MBBS FRCA BSUH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms