Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Accuracy of the Drager Dual-sensor Temperature Measurement System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
Andrea Kurz, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE September 18, 2009
First Posted Date  ICMJE September 21, 2009
Results First Submitted Date  ICMJE April 6, 2017
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE March 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
1. To determine if the Drager dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate for routine clinical use during surgery and during post-anesthetic recovery [ Time Frame: During and post surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • Sensitivity for Detection of Hypothermia [ Time Frame: From anesthesia induction to the end of surgery ]
    Hypothermia is defined as a temperature < 36 Celsius degree
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
To evaluate whether commonly used systems are accurate for routine clinical use [ Time Frame: During and post-surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accuracy of the Drager Dual-sensor Temperature Measurement System
Official Title  ICMJE Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hypothermia; Anesthesia
Intervention  ICMJE
  • 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.
  • Device: Foley catheter temperature sensor
    Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery
Study Arms  ICMJE
  • General anesthesia
    Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
    Interventions:
    • Device: Draeger double-sensor
    • Device: Esophageal stethoscope temperature sensor
  • Regional anesthesia
    Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
    Interventions:
    • Device: Draeger double-sensor
    • Device: Foley catheter temperature sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2017)
56
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2009)
50
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00980642
Other Study ID Numbers  ICMJE 08-453
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Kurz, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Kurz, M.D. The Cleveland Clinic
Study Chair: Daniel I Sessler, M.D. The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP