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

March 8, 2017 updated by: d sessler, The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bair Hugger heated blanket
Patients will be warmed during surgery with the Bair Hugger heated blanket.
Device: heated blanket
heated blanket
Other Names:
  • 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 Names:
  • LMA PerfecTemp system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from tracheal intubation to 3 hours after or tracheal extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Daniel I Sessler, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10-146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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