Trial Outcomes & Findings for Comparison Study of Core Temperature Thermometry Systems (NCT NCT01255865)

Last Updated: 2020-08-25

Results Overview

Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures.

Recruitment status

COMPLETED

Target enrollment

111 participants

Primary outcome timeframe

Upon enrollment

Results posted on

2020-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Age 1 Age group 0 up to 1 month	Age 2 Age group from 1 month to 3 months	Age 3 Age group from 3 months to 1 year	Age 4 Age group from older than 1y and younger than 5 years	Age 5 Age group from older than 5y and younger than 12 years	Age 6 Age group from older than 12 years and younger than 21 years	Age 7 Age group older than 21 years
Overall Study STARTED	1	10	10	30	20	20	20
Overall Study COMPLETED	1	10	10	30	20	20	20
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Study of Core Temperature Thermometry Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age1 n=1 Participants Age group 0 up to 1 month	Age2 n=10 Participants Age group from 1 month to 3 months	Age3 n=10 Participants Age group from 3 months to 1 year	Age4 n=30 Participants Age group from older than 1y and younger than 5 years	Age5 n=20 Participants Age group from older than 5y and younger than 12 years	Age6 n=20 Participants Age group from older than 12 years and younger than 21 years	Age7 n=20 Participants Age group older than 21 years	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants	20 Participants n=21 Participants	20 Participants n=10 Participants	0 Participants n=115 Participants	91 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	20 Participants n=115 Participants	20 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=4 Participants	NA years STANDARD_DEVIATION NA • n=21 Participants	NA years STANDARD_DEVIATION NA • n=10 Participants	NA years STANDARD_DEVIATION NA • n=115 Participants	NA years STANDARD_DEVIATION NA • n=6 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	14 Participants n=21 Participants	9 Participants n=10 Participants	12 Participants n=115 Participants	50 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants	6 Participants n=21 Participants	11 Participants n=10 Participants	8 Participants n=115 Participants	61 Participants n=6 Participants
Region of Enrollment United States	1 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants	20 participants n=21 Participants	20 participants n=10 Participants	20 participants n=115 Participants	111 participants n=6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Age1 n=1 Participants Age group 0 up to 1 month	Age2 n=10 Participants Age group from 1 month to 3 months	Age3 n=10 Participants Age group from 3 months to 1 year	Age4 n=30 Participants Age group from older than 1y and younger than 5 years	Age5 n=20 Participants Age group from older than 5y and younger than 12 years	Age6 n=20 Participants Age group from older than 12 years and younger than 21 years	Age7 n=20 Participants Age group older than 21 years
Temperature Agreement in Degrees Celsius.	NA Temperature in Celsius Standard Deviation NA Only a single subject in this group so mean and SD at not calculated	0.5 Temperature in Celsius Standard Deviation 0.59	0.5 Temperature in Celsius Standard Deviation 0.47	0.4 Temperature in Celsius Standard Deviation 0.43	0.5 Temperature in Celsius Standard Deviation 0.32	0.3 Temperature in Celsius Standard Deviation 0.47	0.0 Temperature in Celsius Standard Deviation 0.02

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Terri White

Phone: 651-733-0228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place