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OpenTrials
Completed

NCT Number: NCT01094119

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.

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Key information

Conditions

Warming Systems During Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heated blanket

Device

heated blanket

Other names: Bair Hugger

heated pad

Device

patients will be warmed with a heated pad during surgery.

Other names: LMA PerfecTemp system

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 26, 2010
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.