Temperature Measurement in Post-Anesthesia Care Units

Completed

• Conditions: Laparoscopic Surgery; Surgery; Postoperative; General Anesthesia
• Interventions: Device: Body temperature thermometers

• Registration Number: NCT00614588
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observation group	Body temperature thermometers	Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.

Primary Outcome Measures

Name	Time	Method
To determine the accuracy of various temperature-monitoring methods and sites suitable for Post Anesthesia Care Unit use.	Discharge from Post Anesthesia Care Unit

Secondary Outcome Measures

Name	Time	Method
To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit.	PostAnesthesia Care Unit

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States