Accuracy of the Drager Dual-sensor Temperature Measurement System

NCT00980642 | Completed Results

• 1 other identifier: 08-453
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Anesthesia

Keywords

surgery; thermometer; non-invasive; interoperative core temperature; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  From anesthesia induction to the end of surgery

Secondary Outcomes (2)

• Sensitivity for Detection of Hypothermia

  From anesthesia induction to the end of surgery

• Specificity for Detection of Hypothermia

  From anesthesia induction to the end of surgery

Study Arms (2)

General anesthesia

OTHER

Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.

Device: Draeger double-sensor; Device: Esophageal stethoscope temperature sensor

Regional anesthesia

OTHER

Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.

Device: Draeger double-sensor; Device: Foley catheter temperature sensor

Interventions

Draeger double-sensor DEVICE

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.

General anesthesia; Regional anesthesia

Esophageal stethoscope temperature sensor DEVICE

Esophageal temperature is measured by sensors incorporated into an esophageal stethoscope during the surgery.

General anesthesia

Foley catheter temperature sensor DEVICE

Urinary bladder temperature is measured via a sensor incorporated into a Foley catheter during the surgery

Regional anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Andrea Kurz
• Organization: Cleveland Clinic

KURZA@ccf.org

216 445-9924

Study Officials

• Andrea Kurz, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, M.D.

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: March 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Locations

US (1)