Temperature Measurement in Post-Anesthesia Care Units

Surgery Clinical Trial

Official title:

Accuracy of Temperature Measurement in Post-Anesthesia Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614588
• Other study ID #: 07-986
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: July 18, 2016
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: July 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• General Anesthesia
• Laparoscopic Surgery
• Postoperative
• Surgery

Intervention

Device:
• Body temperature thermometers
Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the accuracy of various temperature-monitoring methods and sites suitable for Post Anesthesia Care Unit use.		Discharge from Post Anesthesia Care Unit	No
Secondary	To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit.		PostAnesthesia Care Unit	No