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A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01094119
First received: March 25, 2010
Last updated: January 5, 2011
Last verified: January 2011

March 25, 2010
January 5, 2011
March 2010
August 2010   (final data collection date for primary outcome measure)
PerfecTemp compared to forced-air warming [ Time Frame: two hours of surgery ] [ Designated as safety issue: No ]
temperature area under the curve (36*C baseline)
Same as current
Complete list of historical versions of study NCT01094119 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air

Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia.

Secondary hypotheses include that:

  1. intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming
  2. final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming
  3. final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Warming Systems During Surgery
  • Device: heated blanket
    heated blanket
    Other Name: Bair Hugger
  • Device: heated pad
    patients will be warmed with a heated pad during surgery.
    Other Name: LMA PerfecTemp system
  • Active Comparator: Bair Hugger heated blanket
    Patients will be warmed during surgery with the Bair Hugger heated blanket.
    Intervention: Device: heated blanket
  • Active Comparator: LMA PerfecTemp system
    Patients will be warmed during surgery with the PerfecTemp heated pad .
    Intervention: Device: heated pad
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body-mass index 20-36 kg/m2
  • Age 18-75 yrs
  • ASA Physical Status 1-3
  • Supine position (with or without lithotomy)

Exclusion Criteria:

  • Pre-operative fever
  • Serious skin lesions
  • And contraindication to either PerfecTemp or forced-air warming
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01094119
10-146
No
Daniel Sessler, MD, Cleveland Clinic
Outcomes Research Consortium
Not Provided
Principal Investigator: Daniel I Sessler, MD The Cleveland Clinic
Outcomes Research Consortium
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP