A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
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|ClinicalTrials.gov Identifier: NCT01094119|
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : April 19, 2017
Last Update Posted : April 19, 2017
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:
- intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.
|Condition or disease||Intervention/treatment||Phase|
|Warming Systems During Surgery||Device: heated blanket Device: heated pad||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Active Comparator: Bair Hugger heated blanket
Patients will be warmed during surgery with the Bair Hugger heated blanket.
Device: heated blanket
Other Name: Bair Hugger
Active Comparator: LMA PerfecTemp system
Patients will be warmed during surgery with the PerfecTemp heated pad .
Device: heated pad
patients will be warmed with a heated pad during surgery.
Other Name: LMA PerfecTemp system
- 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
- 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
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): NCT01094119
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Daniel I Sessler, MD||The Cleveland Clinic|