Accuracy of the Drager Dual-sensor Temperature Measurement System

May 15, 2017 updated by: Andrea Kurz, The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: General anesthesia
Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
Device: 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.
Device: Esophageal stethoscope temperature sensor
Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.
Other: Regional anesthesia
Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Device: 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.
Device: Foley catheter temperature sensor
Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Andrea Kurz, M.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-453

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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