Trial Outcomes & Findings for Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia (NCT NCT01119248)

Results Overview

Axillary temperature was measured with MRI-compatible Tempa dot immediately before general anesthesia was induced. Second axillary temperature reading was taken at the conclusion of the MRI scan before emergence from general anesthesia. Room temperature was measured with a digital thermometer placed in scanner room outside the magnet range.

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

prior to induction of general anesthesia and at conclusion of MRI an average of two hours

Results posted on

2018-06-27

Participant Flow

Subjects were recruited in radiology department in MRI holding area.

Participant milestones

Participant milestones
Measure	Children Undergoing MRI children ages 6 months to 8 years scheduled for MRI under general anesthesia
Overall Study STARTED	120
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Children Undergoing MRI children ages 6 months to 8 years scheduled for MRI under general anesthesia
Overall Study Physician Decision	5

Baseline Characteristics

Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Not Applicable n=120 Participants prospective observational cohort study
Age, Categorical <=18 years	120 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	57 Participants n=93 Participants
Sex: Female, Male Male	63 Participants n=93 Participants
Region of Enrollment United States	120 participants n=93 Participants
Body Surface Area (BSA)	0.68 m² n=93 Participants

PRIMARY outcome

Timeframe: prior to induction of general anesthesia and at conclusion of MRI an average of two hours

Population: 120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient

Axillary temperature was measured with MRI-compatible Tempa dot immediately before general anesthesia was induced. Second axillary temperature reading was taken at the conclusion of the MRI scan before emergence from general anesthesia. Room temperature was measured with a digital thermometer placed in scanner room outside the magnet range.

Outcome measures

Outcome measures
Measure	Children Undergoing MRI n=115 Participants children 6 months to 8 years requiring GA for MRI
Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI preMRI temperature	36.7 celsius degrees Interval 35.7 to 37.7
Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI post MRI temperature	36.3 celsius degrees Interval 34.3 to 38.1
Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI difference in body temperature	-0.4 celsius degrees Interval -2.9 to 1.6
Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI Pre MRI room temperature	21.1 celsius degrees Interval 16.1 to 25.6
Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI post MRI room temperature	21.3 celsius degrees Interval 16.1 to 25.6
Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI Difference in Room temperature	0.2 celsius degrees Interval 0.1 to 0.3

SECONDARY outcome

Timeframe: Prior to start of general anesthesia and immediately after completion of MRI an average of two hours

Population: 120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient

Bivariate analysis between pre MRI body temperature and change in body temperature after MRI. Body temperature of the subjects was measured with MRI compatible Tempadot. Reported is the change in body temperature after MRI with 1 degree increase in body temperature between subjects after adjusting for body surface area (BSA), type of MRI and duration of MRI. A positive change value reflects a child who was 1 degree C warmer experienced greater warming. The negative change reflects that a child who was 1 degree C warmer experienced greater cooling.

Outcome measures

Outcome measures
Measure	Children Undergoing MRI n=115 Participants children 6 months to 8 years requiring GA for MRI
Relationship Between Pre MRI Body Temperature and Change in Body Temperature After MRI	-0.69 celsius degrees Interval -0.95 to -0.43

SECONDARY outcome

Timeframe: Prior to start of general anesthesia and immediately after completion of MRI scan an average of two hours

Population: 120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient

Bivariate analysis between BSA and change in body temperature after MRI. Reported is the change in body temperature after MRI with 1m2 increase in BSA, after adjusting type of MRI and duration of MRI. A positive change value reflects increase in body temperature with an increase in BSA and vice versa

Outcome measures

Outcome measures
Measure	Children Undergoing MRI n=115 Participants children 6 months to 8 years requiring GA for MRI
Relationship Between Body Surface Area (BSA) and Change in Body Temperature After MRI	.52 celsius degrees Interval 0.23 to 0.82

Adverse Events

Children Undergoing MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anuradha Patel, MD Director of Pediatric Anesthesiology

Rutgers/New Jersey Medical School

Phone: 973 972-1886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place