Accuracy of the Drager Dual-sensor Temperature Measurement System

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00980642
First received: September 18, 2009
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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 Intervention
Fever
Device: Draeger double sensor

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 1.Temperature as recorded by Draeger Dual-Sensor [ Time Frame: Day one ] [ Designated as safety issue: No ]
    1.determine if the Drager dual-sensor temperature monitoring system, used at the forehead is accurate when compared to compared to tympanic, bladder, esophageal or oral temperatures.


Enrollment: 75
Study Start Date: March 2010
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Draeger double sensor
    1. Draeger double sensor system on the forehead (central)
    2. Draeger double sensor system on forehead (peripheral)
    3. Skin temperature sensor system (calf)
    4. Skin temperature sensor system (upper arm)
  Eligibility

Ages Eligible for Study:   6 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion: regional anesthesia (orthopedic, urology)

  • pediatric patients undergoing general surgery
  • Patients undergoing regional anesthesia
  • pediatric patients
  • patients who develop fever during their hospital stay (non-operative patient population).

Exclusion: younger than 6 or older than 80 years of age

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980642

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

No publications provided

Responsible Party: Andrea Kurz, M.D., Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00980642     History of Changes
Other Study ID Numbers: 08-453
Study First Received: September 18, 2009
Last Updated: August 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
surgery
temperature
temperature monitor
non-invasive
interoperative core temperature

ClinicalTrials.gov processed this record on August 18, 2014