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
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Sponsor:
The Cleveland Clinic
Information provided by (Responsible Party):
Andrea Kurz, The Cleveland Clinic
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | General Anesthesia | Regional Anesthesia | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 36 participants | 20 participants | 56 participants | |
64
(19 to 80)
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65
(47 to 79)
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64
(30 to 80)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 36 participants | 20 participants | 56 participants | |
Female |
22 61.1%
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13 65.0%
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35 62.5%
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Male |
14 38.9%
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7 35.0%
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21 37.5%
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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 |
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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 |
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Number Analyzed | 36 participants | 20 participants | 56 participants | |
2.0
(1.1 to 3.0)
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1.2
(0.7 to 1.5)
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1.8
(1.0 to 2.2)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Andrea Kurz |
Organization: | Cleveland Clinic |
Phone: | 216 445-9924 |
EMail: | KURZA@ccf.org |
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 |