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
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia; Anesthesia||Device: Draeger double-sensor Device: Esophageal stethoscope temperature sensor Device: Foley catheter temperature sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||August 2012|
Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
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.
Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
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: Foley catheter temperature sensor
Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980642
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Andrea Kurz, M.D.||The Cleveland Clinic|
|Study Chair:||Daniel I Sessler, M.D.||The Cleveland Clinic|