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Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia

Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01119248
Enrollment
120
Registered
2010-05-07
Start date
2010-03-31
Completion date
2011-12-31
Last updated
2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Requiring MRI

Keywords

Children MRI General Anesthesia

Brief summary

The number of children undergoing MRI imaging has increased significantly in the past years, because many young children cannot stay still for the duration of the scan, have difficulty tolerating the confined space and the noise produced by the Magnetic Resonance Imaging (MRI) machine, sedation or General Anesthesia is required in these cases. In the investigators institution, the investigators use General Anesthesia for children undergoing MRI. Because children have a larger surface area to body weight ratio; hypothermia from passive heat loss is one of the anesthesiologists' concerns. MRI requires a cool environment with low humidity; this specialized environment represents a significant thermal challenge to the anesthetized children. Since most temperature devices are not compatible with the MRI, the simple task to measure temperature change has never been investigated.

Detailed description

It is known that following the induction of anesthesia, core hypothermia occurs in three stages; 1. Redistribution 2. Linear phase 3. Plateau phase Redistribution This accounts for the largest drop in core temperature of the three stages. Vasodilatation causes redistribution of heat from the core to the periphery. Linear Phase This begins at the start of surgery as the patient is exposed to cold cleaning fluids and cool air flow in the theatre. Heat loss exceeds heat production, and most surgery does not extend past the linear phase. * Radiation contributes the most (40%) and is proportional to environment/core, temperature difference to the power of four. * Convection contributes up to 30% and is proportional to air velocity. * Conduction contributes up to 5% and is proportional to the difference in surface temperatures. * Evaporation contributes up to 15% and occurs from cleaning fluids, skin, respiratory and wound. A laparotomy can contribute up to 50% of the total. * Respiratory contributes 10% (8% evaporation of water; 2% heating of air) and is enhanced by the cooling effect of cold anesthetic gases. * Cold intravenous fluids. Plateau Phase Once core temperature falls below the thermoregulatory threshold, peripheral vasoconstriction increases and acts to limit the heat loss from the core department. When core heat production = heat loss to the peripheral compartment, core temperature reaches a plateau. Patients with an autonomic neuropathy (diabetics) have impaired sympathetic vasoconstriction and are unable to establish a core plateau in phase 3. Combined general and regional anesthesia will have a similar effect as the regional anesthetic (spinal/epidural) will prevent vasoconstriction in the legs; i.e. failure to establish a core plateau. The ability to maintain body temperature is also compromised because anesthesia impairs intrinsic thermoregulatory response. Heating devices including fluid warmers and bear huggers, commonly used in the Operating Room theaters, are incompatible with MRI. On the other hand, MRI produces Radiofrequency Energy that transforms into heat within the patient's tissues. This may partially offset the heat loss. The purpose of our study is to determine if children undergoing MRI under General Anesthesia become hypothermic and whether aggressive measures should be taken to prevent passive heat loss during MRI studies. Study Design This is an observational, prospective non blinded study.

Interventions

OTHERaxillary temperature before MRI and after the MRI

observation of body temperature changes with axillary temperature measurement with MRI compatible device

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
No

Inclusion criteria

* 6 months to 8 years undergoing general anesthesia for elective MRI of brain, spine and extremities. Patients who were ASA physical status 1-3 only were included.

Exclusion criteria

Patients who were ASA 4-5 were excluded from the study. Patients not NPO for solids for 8 hours and liquids for 2 hours were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRIprior to induction of general anesthesia and at conclusion of MRI an average of two hoursAxillary 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.

Secondary

MeasureTime frameDescription
Relationship Between Pre MRI Body Temperature and Change in Body Temperature After MRIPrior to start of general anesthesia and immediately after completion of MRI an average of two hoursBivariate 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.
Relationship Between Body Surface Area (BSA) and Change in Body Temperature After MRIPrior to start of general anesthesia and immediately after completion of MRI scan an average of two hoursBivariate 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

Countries

United States

Participant flow

Recruitment details

Subjects were recruited in radiology department in MRI holding area.

Participants by arm

ArmCount
Not Applicable
prospective observational cohort study
120
Total120

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision5

Baseline characteristics

CharacteristicNot Applicable
Age, Categorical
<=18 years
120 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Body Surface Area (BSA)0.68 m²
Region of Enrollment
United States
120 participants
Sex: Female, Male
Female
57 Participants
Sex: Female, Male
Male
63 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 120
serious
Total, serious adverse events
0 / 120

Outcome results

Primary

Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI

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.

Time frame: 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

ArmMeasureGroupValue (MEAN)
Children Undergoing MRIChange in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRIpreMRI temperature36.7 celsius degrees
Children Undergoing MRIChange in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRIpost MRI temperature36.3 celsius degrees
Children Undergoing MRIChange in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRIdifference in body temperature-0.4 celsius degrees
Children Undergoing MRIChange in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRIPre MRI room temperature21.1 celsius degrees
Children Undergoing MRIChange in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRIpost MRI room temperature21.3 celsius degrees
Children Undergoing MRIChange in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRIDifference in Room temperature0.2 celsius degrees
p-value: <0.00195% CI: [-0.48, -0.25]t-test, 2 sided
Secondary

Relationship Between Body Surface Area (BSA) and Change in Body Temperature After MRI

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

Time frame: 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

ArmMeasureValue (NUMBER)
Children Undergoing MRIRelationship Between Body Surface Area (BSA) and Change in Body Temperature After MRI.52 celsius degrees
p-value: 0.001t-test, 2 sided
Secondary

Relationship Between Pre MRI Body Temperature and Change in Body Temperature After MRI

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.

Time frame: 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

ArmMeasureValue (MEAN)
Children Undergoing MRIRelationship Between Pre MRI Body Temperature and Change in Body Temperature After MRI-0.69 celsius degrees
Comparison: pre- MRI body temperature was associated with change in body temperature after MRI by bivariate analysis. The values presented are adjusted for body surface area, type of MRI, room temperature and duration of MRIp-value: 0.000195% CI: [-0.95, -0.43]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026