N/A N=56 Other

Accuracy of the Drager Dual-sensor Temperature Measurement System

Hypothermia; Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT00980642 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature — -0.01; -0.13 Celsius degree

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Draeger double-sensor (Device); Esophageal stethoscope temperature sensor (Device); Foley catheter temperature sensor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature	-0.01; -0.13	—
SECONDARY Sensitivity for Detection of Hypothermia	0.70; 0.83	—
SECONDARY Specificity for Detection of Hypothermia	0.78; 0.69	—

Summary

Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever.

Eligibility Criteria

Inclusion Criteria

Patients undergoing trauma surgery with general anesthesia
Patients undergoing orthopedic surgery with regional anesthesia

Exclusion Criteria

Younger than 18 or older than 80 years of age
Have a pre-existing nasogastric tube
Require bispectral index monitoring
Upper esophageal disease
Forehead rash or infection
Oral infection or trauma
Ear infection or drainage

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00980642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.