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Completed

NCT Number: NCT00614588

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.

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Key information

Conditions

Surgery General Anesthesia Laparoscopic Surgery Postoperative

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Body temperature thermometers

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Accuracy of Temperature Measurement in Post-Anesthesia Care Units

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2008
Registry last updated
Jul 20, 2016

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.

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