Accuracy of the Drager Dual-sensor Temperature Measurement System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothermia; Anesthesia

Intervention / Treatment
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* Device: Draeger double-sensor
* Device: Esophageal stethoscope temperature sensor
* Device: Foley catheter temperature sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: General anesthesia<br>Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. | Device: Draeger double-sensor<br>* The sensor will be attached to the patient's forehead with adhesive tape, and a small amount of contact gel will be applied between sensor and skin.<br>Device: Esophageal stethoscope temperature sensor<br>* Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.<br>|
| Other: Regional anesthesia<br>Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery. | Device: Draeger double-sensor<br>* The sensor will be attached to the patient's forehead with adhesive tape, and a small amount of contact gel will be applied between sensor and skin.<br>Device: Foley catheter temperature sensor<br>* Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature | 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. | From anesthesia induction to the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for Detection of Hypothermia | Hypothermia is defined as a temperature < 36 Celsius degree | From anesthesia induction to the end of surgery | 
| Specificity for Detection of Hypothermia | Hypothermia will be defined as a temperature < 36 Celsius degree | From anesthesia induction to the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, thermometer, non-invasive, interoperative core temperature, anesthesia