Body Temperature, Temperature, Thermosensing
Conditions
Keywords
Deep Tissue Temperature, Zero Heat Flux Thermometry, Thermometry, Core Temperature
Brief 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.
Detailed 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.
Interventions
DEVICEZero-heat-flux thermometry
The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.
Sponsors
3M
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Temperature Difference in Degrees Celsius | Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes. | Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zero-Heat-Flux This is a single arm study. All patients will have deep tissue temperature monitored from the nasopharyngeal and lateral forehead sites simultaneously.
Zero-heat-flux thermometry: The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Zero-Heat-Flux |
|---|---|
| Age, Categorical <=18 years | 20 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 7.1 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 11 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Body Temperature Difference in Degrees Celsius
Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.
Time frame: Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Zero-Heat-Flux | Body Temperature Difference in Degrees Celsius | -0.28 Degrees Celsius | Standard Error 0.027 |
p-value: 0.69ANOVA