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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.
It is known that following the induction of anesthesia, core hypothermia occurs in three stages;
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children undergoing MRI | 120 children ages of 6 months and 8 years for MRI and axillary temperature before MRI and after the MRI with MRI compatible device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| axillary temperature before MRI and after the MRI | Other | observation of body temperature changes with axillary temperature measurement with MRI compatible device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | prior to induction of general anesthesia and at conclusion of MRI an average of two hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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Children 6 months to 8 years
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| Name | Affiliation | Role |
|---|---|---|
| Anuradha Patel, MD | Rutgers-NJMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Newark | New Jersey | 07101 | United States |
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Subjects were recruited in radiology department in MRI holding area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Children Undergoing MRI | children ages 6 months to 8 years scheduled for MRI under general anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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children scheduled for MRI under general anesthesia
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| ID | Title | Description |
|---|---|---|
| BG000 | Not Applicable | prospective observational cohort study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Full Range | celsius degrees | prior to induction of general anesthesia and at conclusion of MRI an average of two hours |
|
until subject had fully recovered from anesthesia and was ready for discharge up to 2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children Undergoing MRI | infants 6 months to children 8 years |
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There was difficulty in collecting data due to the restricted MRI environment. We used Tempadot which is not a digital or electronic temperature measurement device and is MRI compatible, but the device may not be as accurate as the other devices
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anuradha Patel, MD Director of Pediatric Anesthesiology | Rutgers/New Jersey Medical School | 973 972-1886 | patelan@njms.rutgers.edu |
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| Prior to start of general anesthesia and immediately after completion of MRI an average of two hours |
| 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 | Prior to start of general anesthesia and immediately after completion of MRI scan an average of two hours |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Surface Area (BSA) | Mean | Full Range | m² |
|
children 6 months to 8 years requiring GA for MRI
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| 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. | 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 | Posted | Mean | 95% Confidence Interval | celsius degrees | Prior to start of general anesthesia and immediately after completion of MRI an average of two hours |
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|
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| 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 | 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 | Posted | Number | 95% Confidence Interval | celsius degrees | Prior to start of general anesthesia and immediately after completion of MRI scan an average of two hours |
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| 0 |
| 120 |
| 0 |
| 120 |
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