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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
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 d sessler, The Cleveland Clinic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01094119


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

Responsible Party: d sessler, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01094119     History of Changes
Other Study ID Numbers: 10-146
First Submitted: March 25, 2010
First Posted: March 26, 2010
Results First Submitted: November 29, 2016
Results First Posted: April 19, 2017
Last Update Posted: April 19, 2017
Last Verified: March 2017

Keywords provided by d sessler, The Cleveland Clinic:
heated blanket
heated pad