Accuracy of the Drager Dual-sensor Temperature Measurement System

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
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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

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.
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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)

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 ]

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
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