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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):
Andrea Kurz, The Cleveland Clinic

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
Enrollment 56
Recruitment Details 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  
Arm/Group Title General Anesthesia Regional Anesthesia
Hide Arm/Group Description Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Period Title: Overall Study
Started 36 20
Completed 36 20
Not Completed 0 0
Arm/Group Title General Anesthesia Regional Anesthesia Total
Hide Arm/Group Description Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery. Total of all reporting groups
Overall Number of Baseline Participants 36 20 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 36 participants 20 participants 56 participants
64
(19 to 80)
65
(47 to 79)
64
(30 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 20 participants 56 participants
Female
22
  61.1%
13
  65.0%
35
  62.5%
Male
14
  38.9%
7
  35.0%
21
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 20 participants 56 participants
United States 0 20 20
Austria 36 0 36
Ambient temperature  
Mean (Standard Deviation)
Unit of measure:  Celsius degree
Number Analyzed 36 participants 20 participants 56 participants
19.2  (1.2) 19.5  (1.0) 19.4  (1.1)
Duration of surgery  
Median (Inter-Quartile Range)
Unit of measure:  Hours
Number Analyzed 36 participants 20 participants 56 participants
2.0
(1.1 to 3.0)
1.2
(0.7 to 1.5)
1.8
(1.0 to 2.2)
1.Primary Outcome
Title The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature
Hide Description 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.
Time Frame From anesthesia induction to the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title General Anesthesia Regional Anesthesia
Hide Arm/Group Description:
Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery
Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Overall Number of Participants Analyzed 36 20
Mean (95% Confidence Interval)
Unit of Measure: Celsius degree
-0.01
(-0.61 to 0.59)
-0.13
(-0.65 to 0.40)
2.Secondary Outcome
Title Sensitivity for Detection of Hypothermia
Hide Description Hypothermia is defined as a temperature < 36 Celsius degree
Time Frame From anesthesia induction to the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title General Anesthesia Regional Anesthesia
Hide Arm/Group Description:
Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Overall Number of Participants Analyzed 36 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of hypothermias
0.70
(0.48 to 1.00)
0.83
(0.68 to 1.00)
3.Secondary Outcome
Title Specificity for Detection of Hypothermia
Hide Description Hypothermia will be defined as a temperature < 36 Celsius degree
Time Frame From anesthesia induction to the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title General Anesthesia Regional Anesthesia
Hide Arm/Group Description:
Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Overall Number of Participants Analyzed 36 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of non-hypothermias
0.78
(0.68 to 0.95)
0.69
(0.34 to 1.00)
Time Frame through study completion, an average of 3 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title General Anesthesia Regional Anesthesia
Hide Arm/Group Description Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery. Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
All-Cause Mortality
General Anesthesia Regional Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
General Anesthesia Regional Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
General Anesthesia Regional Anesthesia
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Andrea Kurz
Organization: Cleveland Clinic
Phone: 216 445-9924
EMail: KURZA@ccf.org
Layout table for additonal information
Responsible Party: Andrea Kurz, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00980642    
Other Study ID Numbers: 08-453
First Submitted: September 18, 2009
First Posted: September 21, 2009
Results First Submitted: April 6, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017