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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01094119
First Posted: March 26, 2010
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
d sessler, The Cleveland Clinic
March 25, 2010
March 26, 2010
November 29, 2016
April 19, 2017
April 19, 2017
March 2010
August 2010   (Final data collection date for primary outcome measure)
Time Weighted Average Core Temperature [ Time Frame: from tracheal intubation to 3 hours after or tracheal extubation ]
Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation
PerfecTemp compared to forced-air warming [ Time Frame: two hours of surgery ]
temperature area under the curve (36*C baseline)
Complete list of historical versions of study NCT01094119 on ClinicalTrials.gov Archive Site
Proportion of Patients With Temperatures Above 36 Degree [ Time Frame: at the end of surgery ]
Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01094119
10-146
No
Not Provided
Not Provided
d sessler, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Daniel I Sessler, MD The Cleveland Clinic
The Cleveland Clinic
March 2017

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