Temperature Measurement in Post-Anesthesia Care Units

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. Identifier: NCT00614588
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
The Cleveland Clinic

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

Condition or disease Intervention/treatment
Surgery Postoperative Laparoscopic Surgery General Anesthesia Device: Body temperature thermometers

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
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of Temperature Measurement in Post-Anesthesia Care Units
Study Start Date : January 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit. [ Time Frame: PostAnesthesia Care Unit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.

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

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 identifier (NCT number): NCT00614588

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Principal Investigator: Daniel I Sessler, MD The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT00614588     History of Changes
Other Study ID Numbers: 07-986
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by The Cleveland Clinic:

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs