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Accuracy of the Drager Dual-sensor Temperature Measurement System

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ClinicalTrials.gov Identifier: NCT00980642
Recruitment Status : Completed
First Posted : September 21, 2009
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypothermia; Anesthesia Device: Draeger double-sensor Device: Esophageal stethoscope temperature sensor Device: Foley catheter temperature sensor

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period
Study Start Date : March 2010
Primary Completion Date : February 2012
Study Completion Date : August 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sensitivity for Detection of Hypothermia [ Time Frame: From anesthesia induction to the end of surgery ]
    Hypothermia is defined as a temperature < 36 Celsius degree

  2. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980642


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Andrea Kurz, M.D. The Cleveland Clinic
Study Chair: Daniel I Sessler, M.D. The Cleveland Clinic
More Information

Responsible Party: Andrea Kurz, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00980642     History of Changes
Other Study ID Numbers: 08-453
First Posted: September 21, 2009    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017

Keywords provided by Andrea Kurz, The Cleveland Clinic:
surgery
thermometer
non-invasive
interoperative core temperature
anesthesia

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs