This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Accuracy of the Drager Dual-sensor Temperature Measurement System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Kurz, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00980642
First received: September 18, 2009
Last updated: May 15, 2017
Last verified: May 2017
Results First Received: April 6, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Hypothermia; Anesthesia
Interventions: Device: Draeger double-sensor
Device: Esophageal stethoscope temperature sensor
Device: Foley catheter temperature sensor

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients having trauma surgery with general anesthesia were recruited from the University of Vienna, while patients having orthopedic surgery with regional anesthesia were recruited from the Cleveland Clinic from January 2009 to June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
General Anesthesia Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
Regional Anesthesia Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.

Participant Flow:   Overall Study
    General Anesthesia   Regional Anesthesia
STARTED   36   20 
COMPLETED   36   20 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
General Anesthesia Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
Regional Anesthesia Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Total Total of all reporting groups

Baseline Measures
   General Anesthesia   Regional Anesthesia   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   20   56 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 64 
 (19 to 80) 
 65 
 (47 to 79) 
 64 
 (30 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      22  61.1%      13  65.0%      35  62.5% 
Male      14  38.9%      7  35.0%      21  37.5% 
Region of Enrollment 
[Units: Participants]
     
United States   0   20   20 
Austria   36   0   36 
Ambient temperature 
[Units: Celsius degree]
Mean (Standard Deviation)
 19.2  (1.2)   19.5  (1.0)   19.4  (1.1) 
Duration of surgery 
[Units: Hours]
Median (Inter-Quartile Range)
 2.0 
 (1.1 to 3.0) 
 1.2 
 (0.7 to 1.5) 
 1.8 
 (1.0 to 2.2) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature   [ Time Frame: From anesthesia induction to the end of surgery ]

2.  Secondary:   Sensitivity for Detection of Hypothermia   [ Time Frame: From anesthesia induction to the end of surgery ]

3.  Secondary:   Specificity for Detection of Hypothermia   [ Time Frame: From anesthesia induction to the end of surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Andrea Kurz
Organization: Cleveland Clinic
phone: 216 445-9924
e-mail: KURZA@ccf.org



Responsible Party: Andrea Kurz, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00980642     History of Changes
Other Study ID Numbers: 08-453
Study First Received: September 18, 2009
Results First Received: April 6, 2017
Last Updated: May 15, 2017