Trial Outcomes & Findings for Accuracy of the Drager Dual-sensor Temperature Measurement System (NCT NCT00980642)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

From anesthesia induction to the end of surgery

Results posted on

2017-06-14

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	36	20
Overall Study COMPLETED	36	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of the Drager Dual-sensor Temperature Measurement System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	General Anesthesia n=36 Participants Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.	Regional Anesthesia n=20 Participants Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.	Total n=56 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	65 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	0 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Austria	36 participants n=5 Participants	0 participants n=7 Participants	36 participants n=5 Participants
Ambient temperature	19.2 Celsius degree STANDARD_DEVIATION 1.2 • n=5 Participants	19.5 Celsius degree STANDARD_DEVIATION 1.0 • n=7 Participants	19.4 Celsius degree STANDARD_DEVIATION 1.1 • n=5 Participants
Duration of surgery	2.0 hours n=5 Participants	1.2 hours n=7 Participants	1.8 hours n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	General Anesthesia n=36 Participants Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery	Regional Anesthesia n=20 Participants Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature	-0.01 Celsius degree Interval -0.61 to 0.59	-0.13 Celsius degree Interval -0.65 to 0.4

SECONDARY outcome

Timeframe: From anesthesia induction to the end of surgery

Hypothermia is defined as a temperature \< 36 Celsius degree

Outcome measures

Outcome measures
Measure	General Anesthesia n=36 Participants Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery	Regional Anesthesia n=20 Participants Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Sensitivity for Detection of Hypothermia	0.70 percent of hypothermias Interval 0.48 to 1.0	0.83 percent of hypothermias Interval 0.68 to 1.0

SECONDARY outcome

Timeframe: From anesthesia induction to the end of surgery

Hypothermia will be defined as a temperature \< 36 Celsius degree

Outcome measures

Outcome measures
Measure	General Anesthesia n=36 Participants Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery	Regional Anesthesia n=20 Participants Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Specificity for Detection of Hypothermia	0.78 percent of non-hypothermias Interval 0.68 to 0.95	0.69 percent of non-hypothermias Interval 0.34 to 1.0

Adverse Events

General Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regional Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrea Kurz

Cleveland Clinic

Phone: 216 445-9924

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place