Temperature Measurement in Post-Anesthesia Care Units

July 18, 2016 updated by: The Cleveland Clinic

Accuracy of Temperature Measurement in Post-Anesthesia Care Units

This study will evaluate the accuracy of several thermometers and temperature changes during surgery and immediately after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several measurements of temperature will be taken at 30 minute intervals during surgery under general anesthesia and in the post operative care unit. Measurements will be taken as follows:

  • esophagus using an internal stethoscope
  • urinary bladder using a catheter
  • ear canal
  • skin of the forehead using adhesive devices(4 thermometers)
  • axilla ("armpit") using adhesive devices(2 thermometers)
  • mouth
  • skin of the upper chest

Study Type

Observational

Enrollment (Actual)

50

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.

Description

Inclusion Criteria:

  • 18 to 80 years of age
  • American Society of Anesthesiologists (ASA) physical status of 1-3
  • laparoscopic surgery of the abdomen or pelvis that is expected to require general endotracheal anesthesia and insertion of a Foley catheter expected to be in place for at least one hour after surgery

Exclusion Criteria:

  • under 18 or over 80 years of age
  • pre-existing nasogastric tube
  • require bispectral index monitoring
  • upper esophageal disease
  • forehead rash or infection, oral infection or trauma, or ear infection or drainage

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
observation group
Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.
Device: Body temperature thermometers
Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer.
Other Names:
  • 1. Distal esophagus (Mon-a-therm, Tyco-Mallinckrodt Anesthesia Products,
  • 2. Bladder (Mon-a-therm, Tyco-Mallinckrodt Anesthesia Products,
  • 3. Infrared-aural canal bilaterally (GENIUS Model 3000A, Kendall Healthcare)
  • 4. Temporal artery with an electronic scanning thermometer (Model TAT-5000, Exergen)
  • 5. Posterior sublingual pocket with electronic thermometer (Turbo Temperature Model 2180CX01EE)
  • 6. Forehead skin thermocouple (Mon-a-therm, Tyco-Mallinckrodt Anesthesia Products)
  • 7. Axilla with an electronic probe (Mon-a-therm, Tyco-Mallinckrodt Anesthesia Products)
  • 8. Forehead liquid-crystal (Crystaline II)
  • 9. Intermittent axillary temperature (Turbo Temperature Model 2180CX01EE)
  • 10. "Deep" temperature with a 4-cm probe on the forehead
  • 11. "Deep" temperature with a 7-cm probe over the subclavicular region of the upper chest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the accuracy of various temperature-monitoring methods and sites suitable for Post Anesthesia Care Unit use.
Time Frame: Discharge from Post Anesthesia Care Unit
Discharge from Post Anesthesia Care Unit

Secondary Outcome Measures

Outcome Measure
Time Frame
To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit.
Time Frame: PostAnesthesia Care Unit
PostAnesthesia Care Unit

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

January 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-986

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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