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Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia

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ClinicalTrials.gov Identifier: NCT01119248
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Anuradha Patel, Rutgers, The State University of New Jersey

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Children Requiring MRI
Intervention Other: axillary temperature before MRI and after the MRI
Enrollment 120
Recruitment Details Subjects were recruited in radiology department in MRI holding area.
Pre-assignment Details  
Arm/Group Title Children Undergoing MRI
Hide Arm/Group Description children ages 6 months to 8 years scheduled for MRI under general anesthesia
Period Title: Overall Study
Started 120
Completed 115
Not Completed 5
Reason Not Completed
Physician Decision             5
Arm/Group Title Not Applicable
Hide Arm/Group Description prospective observational cohort study
Overall Number of Baseline Participants 120
Hide Baseline Analysis Population Description
children scheduled for MRI under general anesthesia
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
<=18 years
120
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Female
57
  47.5%
Male
63
  52.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 120 participants
120
Body Surface Area (BSA)  
Mean (Full Range)
Unit of measure:  M²
Number Analyzed 120 participants
0.68
(0.29 to 1.40)
1.Primary Outcome
Title Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Children Undergoing MRI
Hide Arm/Group Description:
children 6 months to 8 years requiring GA for MRI
Overall Number of Participants Analyzed 115
Mean (Full Range)
Unit of Measure: celsius degrees
preMRI temperature
36.7
(35.7 to 37.7)
post MRI temperature
36.3
(34.3 to 38.1)
difference in body temperature
-0.4
(-2.9 to 1.6)
Pre MRI room temperature
21.1
(16.1 to 25.6)
post MRI room temperature
21.3
(16.1 to 25.6)
Difference in Room temperature
0.2
(0.1 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children Undergoing MRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.48 to -0.25
Parameter Dispersion
Type: Standard Deviation
Value: 0.62
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Relationship Between Pre MRI Body Temperature and Change in Body Temperature After MRI
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Children Undergoing MRI
Hide Arm/Group Description:
children 6 months to 8 years requiring GA for MRI
Overall Number of Participants Analyzed 115
Mean (95% Confidence Interval)
Unit of Measure: celsius degrees
-0.69
(-0.95 to -0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children Undergoing MRI
Comments 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 MRI
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.69
Confidence Interval (2-Sided) 95%
-0.95 to -0.43
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Relationship Between Body Surface Area (BSA) and Change in Body Temperature After MRI
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Children Undergoing MRI
Hide Arm/Group Description:
children ages 6 months to 8 years scheduled for MRI under general anesthesia
Overall Number of Participants Analyzed 115
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: celsius degrees
.52
(.23 to .82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Children Undergoing MRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame until subject had fully recovered from anesthesia and was ready for discharge up to 2 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Children Undergoing MRI
Hide Arm/Group Description infants 6 months to children 8 years
All-Cause Mortality
Children Undergoing MRI
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Children Undergoing MRI
Affected / at Risk (%)
Total   0/120 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Children Undergoing MRI
Affected / at Risk (%)
Total   0/120 (0.00%) 
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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Anuradha Patel, MD Director of Pediatric Anesthesiology
Organization: Rutgers/New Jersey Medical School
Phone: 973 972-1886
Responsible Party: Anuradha Patel, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01119248     History of Changes
Other Study ID Numbers: 0120100053
First Submitted: May 6, 2010
First Posted: May 7, 2010
Results First Submitted: September 26, 2016
Results First Posted: June 27, 2018
Last Update Posted: June 27, 2018