Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia
| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2010 | ||||
| Last Updated Date | January 24, 2013 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine temperative change in children undergoing MRI under general anesthesia [ Time Frame: Start of MRI procedure until 30 minutes after its completion ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01119248 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia | ||||
| Official Title ICMJE | Pediatric Temperature Variation in the MRI Scanner Under 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. |
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| Detailed Description | 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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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Children 6 months to 8 years |
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| Condition ICMJE | Children Requiring MRI | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Children undergoing MRI | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 121 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Months to 8 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01119248 | ||||
| Other Study ID Numbers ICMJE | 0120100053 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Medicine and Dentistry New Jersey | ||||
| Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Medicine and Dentistry New Jersey | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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