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
  Purpose

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.

Condition Intervention
Warming Systems During Surgery
Device: heated blanket
Device: heated pad

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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)


Enrollment: 70
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bair Hugger heated blanket
Patients will be warmed during surgery with the Bair Hugger heated blanket.
Device: heated blanket
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094119

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Daniel Sessler, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01094119     History of Changes
Other Study ID Numbers: 10-146
Study First Received: March 25, 2010
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
heated blanket
heated pad

ClinicalTrials.gov processed this record on April 17, 2014