Zero Heat Flux Thermometry System Comparison Trial

3M Company

Status: Completed

Conditions: Thermosensing; Body Temperature; Temperature

Treatments: Device: Zero-heat-flux thermometry

Study type: Interventional

Funder types: Industry

Identifiers

NCT01670760

2012-DTT-BS-01

Details and patient eligibility

About

Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.

Full description

The core temperature of the body normally decreases in response to anesthesia. Deep tissue temperature can be used to estimate of body core temperature. Deep tissue temperature of the forehead will be measured using a new technology known as zero-heat-flux thermometry. The usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.

Enrollment: 20 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Less than or equal to 17 years old
• patients undergoing surgery during which core temperature is estimated
• Willing to participate in trial
• Able to provide consent
• Adequate forehead surface area available for probe attachment
• Urology, orthopedic, or general abdominal surgery

Exclusion criteria

• Skin lesions at thermometer target site
• Infectious disease
• Bleeding disorder
• Prone intraoperative positioning anticipated
• Head and neck procedures
• Cardiothoracic procedures
• Tonsillectomy, cosmetic, or other brief surgical or nonsurgical procedures

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Zero-Heat-Flux

Experimental group

Description:

This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.

Treatment:

Device: Zero-heat-flux thermometry