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NCT00980642 Clinical Trial

Accuracy of the Drager Dual-sensor Temperature Measurement System

Fever Clinical Trial

Official title:
Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00980642
Other study ID # 08-453
Secondary ID
Status Completed
Phase N/A
First received September 18, 2009
Last updated August 27, 2012
Start date March 2010
Est. completion date August 2012

Study information
Verified date August 2012
Source Outcomes Research Consortium
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions , as well as during fever.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date August 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 80 Years
Eligibility Inclusion: regional anesthesia (orthopedic, urology)

- pediatric patients undergoing general surgery

- Patients undergoing regional anesthesia

- pediatric patients

- patients who develop fever during their hospital stay (non-operative patient population).

Exclusion: younger than 6 or older than 80 years of age

- pre-existing nasogastric tube

- require bispectral index monitoring

- upper esophageal disease

- forehead rash or infection

- oral infection or trauma

- ear infection or drainage

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Device:
• Draeger double sensor
Draeger double sensor system on the forehead (central) Draeger double sensor system on forehead (peripheral) Skin temperature sensor system (calf) Skin temperature sensor system (upper arm)

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
Outcomes Research Consortium

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1.Temperature as recorded by Draeger Dual-Sensor 1.determine if the Drager dual-sensor temperature monitoring system, used at the forehead is accurate when compared to compared to tympanic, bladder, esophageal or oral temperatures. Day one No
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