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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014