Accuracy of the Drager Dual-sensor Temperature Measurement System

Not Applicable

Completed

• Conditions: Hypothermia; Anesthesia
• Interventions: Device: Draeger double-sensor; Device: Foley catheter temperature sensor; Device: Esophageal stethoscope temperature sensor

• Registration Number: NCT00980642
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Detailed Description

We will include patients undergoing general anesthesia or regional anesthesia. The temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute interval.

Study Timeline

• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Study Start: 2010-03
• Primary Completion: 2012-02
• Study Completion: 2012-08
• Results First Submitted: 2017-04-06
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Results First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients undergoing trauma surgery with general anesthesia
• Patients undergoing orthopedic surgery with regional anesthesia

Exclusion Criteria

• Younger than 18 or older than 80 years of age
• Have a 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional anesthesia	Draeger double-sensor	Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Regional anesthesia	Foley catheter temperature sensor	Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
General anesthesia	Draeger double-sensor	Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
General anesthesia	Esophageal stethoscope temperature sensor	Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.

Primary Outcome Measures

Name	Time	Method
The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature	From anesthesia induction to the end of surgery	Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group.

Secondary Outcome Measures

Name	Time	Method
Sensitivity for Detection of Hypothermia	From anesthesia induction to the end of surgery	Hypothermia is defined as a temperature \< 36 Celsius degree
Specificity for Detection of Hypothermia	From anesthesia induction to the end of surgery	Hypothermia will be defined as a temperature \< 36 Celsius degree

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States