Temperature Measurement in Post-Anesthesia Care Units

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00614588
First received: January 31, 2008
Last updated: October 22, 2008
Last verified: September 2008
  Purpose

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


Condition Intervention
Surgery
Postoperative
Laparoscopic Surgery
General Anesthesia
Device: Body temperature thermometers

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of Temperature Measurement in Post-Anesthesia Care Units

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit. [ Time Frame: PostAnesthesia Care Unit ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614588

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

No publications provided

Responsible Party: Daniel I. Sessler, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00614588     History of Changes
Other Study ID Numbers: 07-986
Study First Received: January 31, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
temperature
monitor
surgery

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014