Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia

June 25, 2018 updated by: Anuradha Patel, Rutgers, The State University of New Jersey

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Newark, New Jersey, United States, 07101
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children 6 months to 8 years

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
observation of body temperature changes with axillary temperature measurement with MRI compatible device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: prior to induction of general anesthesia and at conclusion of MRI an average of two hours
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship Between Pre MRI Body Temperature and Change in Body Temperature After MRI
Time Frame: Prior to start of general anesthesia and immediately after completion of MRI an average of two hours
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.
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
Time Frame: Prior to start of general anesthesia and immediately after completion of MRI scan an average of two hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anuradha Patel, MD, Rutgers-NJMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (ESTIMATE)

May 7, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 0120100053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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