Children Requiring MRINCT01119248
Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia
An observational study of Children Requiring MRI, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 8 years
- Conditions the study is for
- Children Requiring MRI
- What is being tested?
- axillary temperature before MRI and after the MRI
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 6 months to 8 years
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
It is known that following the induction of anesthesia, core hypothermia occurs in three stages;
- Redistribution
- Linear phase
- 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.
- Conditions
- Children Requiring MRI
- Being tested
- axillary temperature before MRI and after the MRI
- Keywords
- Children MRI General Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary temperature before MRI and after the MRIOther
observation of body temperature changes with axillary temperature measurement with MRI compatible device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: axillary temperature before MRI and after the MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: prior to induction of general anesthesia and at conclusion of MRI an average of two hours
Secondary outcomes (2)
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.
Measured: 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
Measured: Prior to start of general anesthesia and immediately after completion of MRI scan an average of two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Children Requiring MRIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anuradha Patel, Rutgers, The State University of New Jersey
- Investigators
- Anuradha Patel, MD, Principal investigator, Rutgers-NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119248
- Sponsor's protocol ID
- 0120100053
- Status last verified
- Jun 2018
- First submitted
- 6 May 2010
- Last updated
- 27 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Temperature Variation in the MRI Scanner Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01119248
- Acronym / sponsor ID
- 0120100053
- Conditions
- Children Requiring MRI
- Keywords
- Children MRI General Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Posted 27 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Redistribution
- Linear phase
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children undergoing MRI | – | Other: axillary temperature before MRI and after the MRI120 children ages of 6 months and 8 years for MRI and axillary temperature before MRI and after the MRI with MRI compatible device |
Who may qualify
- Ages
- 6 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 6 months to 8 years
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| axillary temperature before MRI and after the MRIobservation of body temperature changes with axillary temperature measurement with MRI compatible device | Other | Children undergoing MRI |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anuradha Patel, MD principal investigator
Rutgers-NJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Requiring MRI, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.