Back to resultsAccuracy of the Drager Dual-sensor Temperature Measurement System
Primary Purpose
Hypothermia; Anesthesia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Draeger double-sensor
Esophageal stethoscope temperature sensor
Foley catheter temperature sensor
Sponsored by
About this trial
This is an interventional other trial for Hypothermia; Anesthesia focused on measuring surgery, thermometer, non-invasive, interoperative core temperature, anesthesia
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
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
General anesthesia
Regional anesthesia
Arm Description
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.
Outcomes
Primary Outcome Measures
The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature
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.
Secondary Outcome Measures
Sensitivity for Detection of Hypothermia
Hypothermia is defined as a temperature < 36 Celsius degree
Specificity for Detection of Hypothermia
Hypothermia will be defined as a temperature < 36 Celsius degree
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00980642
Brief Title
Accuracy of the Drager Dual-sensor Temperature Measurement System
Official Title
Accuracy of the Draeger Dual-sensor Temperature Measurement System in The Perioperative Period
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
We will include patients undergoing general anesthesia or regional anesthesia. The temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute interval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia
Keywords
surgery, thermometer, non-invasive, interoperative core temperature, anesthesia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General anesthesia
Arm Type
Other
Arm Description
Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
Arm Title
Regional anesthesia
Arm Type
Other
Arm Description
Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
Intervention Type
Device
Intervention Name(s)
Draeger double-sensor
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Esophageal stethoscope temperature sensor
Intervention Description
Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.
Intervention Type
Device
Intervention Name(s)
Foley catheter temperature sensor
Intervention Description
Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery
Primary Outcome Measure Information:
Title
The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature
Description
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.
Time Frame
From anesthesia induction to the end of surgery
Secondary Outcome Measure Information:
Title
Sensitivity for Detection of Hypothermia
Description
Hypothermia is defined as a temperature < 36 Celsius degree
Time Frame
From anesthesia induction to the end of surgery
Title
Specificity for Detection of Hypothermia
Description
Hypothermia will be defined as a temperature < 36 Celsius degree
Time Frame
From anesthesia induction to the end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Kurz, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel I Sessler, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Accuracy of the Drager Dual-sensor Temperature Measurement System
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