Temperature Measurement in Post-Anesthesia Care Units

NCT ID: NCT00614588

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-09-30

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

Conditions

Surgery; Postoperative; Laparoscopic Surgery; General Anesthesia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

observation group

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

Body temperature thermometers

Intervention Type: DEVICE

Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer.

Interventions

Body temperature thermometers

Temperature readings every 30 minutes during and post surgery using internal stethoscope, catheter and adhesive patches/electronic thermometer.

Intervention Type: DEVICE

Other Intervention 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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Daniel I Sessler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

07-986

Identifier Type: -

Identifier Source: org_study_id