N/A
N=20
Zero Heat Flux Thermometry System Comparison Trial
Body Temperature · Thermosensing · Temperature
Bottom Line
View on ClinicalTrials.gov: NCT01670760 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Body Temperature Difference in Degrees Celsius — -0.28 Degrees Celsius — p=0.69
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zero-heat-flux thermometry (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- 3M
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Temperature Difference in Degrees Celsius |
-0.28 | 0.69 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01670760). 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.