Accuracy of the Drager Dual-sensor Temperature Measurement System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-08-31

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.

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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.

Conditions

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Hypothermia; Anesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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General anesthesia

Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.

Group Type OTHER

Draeger double-sensor

Intervention Type DEVICE

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.

Esophageal stethoscope temperature sensor

Intervention Type DEVICE

Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.

Regional anesthesia

Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.

Group Type OTHER

Draeger double-sensor

Intervention Type DEVICE

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.

Foley catheter temperature sensor

Intervention Type DEVICE

Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery

Interventions

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Draeger double-sensor

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.

Intervention Type DEVICE

Esophageal stethoscope temperature sensor

Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.

Intervention Type DEVICE

Foley catheter temperature sensor

Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No