Thermometry Device Comparisons
Conditions
Keywords
Thermometry, Deep Tissue Temperature, Core Temperature, Body Temperature, Rectal Temperature, Oral Temperature
Brief summary
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.
Detailed description
The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of premarket notification \[510(k)\] submissions for clinical electronic thermometers and ISO/IEC 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
Interventions
None listed
Sponsors
3M
Study design
Observational model
CASE_CROSSOVER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\-
Exclusion criteria
* Subjects with skin disruptions on the forehead, dysautonomia, spinal cord injury, or taking barbiturates, thyroid preparations, antipsychotics, or who have had a recent (1wk) immunization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature Agreement in Degrees Celsius. | Upon enrollment | Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Age1 Age group 0 up to 1 month | 1 |
| Age2 Age group from 1 month to 3 months | 10 |
| Age3 Age group from 3 months to 1 year | 10 |
| Age4 Age group from older than 1y and younger than 5 years | 30 |
| Age5 Age group from older than 5y and younger than 12 years | 20 |
| Age6 Age group from older than 12 years and younger than 21 years | 20 |
| Age7 Age group older than 21 years | 20 |
| Total | 111 |
Baseline characteristics
| Characteristic | Age2 | Age3 | Age4 | Age5 | Age1 | Age6 | Age7 | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 10 Participants | 30 Participants | 20 Participants | 1 Participants | 20 Participants | 0 Participants | 91 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 20 Participants | 20 Participants |
| Age, Continuous | NA years | NA years | NA years | NA years | NA years | NA years | NA years | NA years |
| Region of Enrollment United States | 10 participants | 10 participants | 30 participants | 20 participants | 1 participants | 20 participants | 20 participants | 111 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 10 Participants | 14 Participants | 0 Participants | 9 Participants | 12 Participants | 50 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 20 Participants | 6 Participants | 1 Participants | 11 Participants | 8 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 10 | 0 / 10 | 0 / 30 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 1 | 0 / 10 | 0 / 10 | 0 / 30 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 1 | 0 / 10 | 0 / 10 | 0 / 30 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Temperature Agreement in Degrees Celsius.
Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures.
Time frame: Upon enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Age1 | Temperature Agreement in Degrees Celsius. | NA Temperature in Celsius | — |
| Age2 | Temperature Agreement in Degrees Celsius. | 0.5 Temperature in Celsius | Standard Deviation 0.59 |
| Age3 | Temperature Agreement in Degrees Celsius. | 0.5 Temperature in Celsius | Standard Deviation 0.47 |
| Age4 | Temperature Agreement in Degrees Celsius. | 0.4 Temperature in Celsius | Standard Deviation 0.43 |
| Age5 | Temperature Agreement in Degrees Celsius. | 0.5 Temperature in Celsius | Standard Deviation 0.32 |
| Age6 | Temperature Agreement in Degrees Celsius. | 0.3 Temperature in Celsius | Standard Deviation 0.47 |
| Age7 | Temperature Agreement in Degrees Celsius. | 0.0 Temperature in Celsius | Standard Deviation 0.02 |