Anesthesia; HypothermiaNCT03150953
Evaluation of a Novel Patient Warming System During MRI
A study testing MRI-safe bore covering in people with Anesthesia; Hypothermia and Congenital Heart Disease, run by Andrew Matisoff at 1 site in United States.
Trial summary
Patients under deep sedation and general anesthesia lose heat to their surrounding environment. Hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular complications. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Anesthesia; Hypothermia, Congenital Heart Disease
- What is being tested?
- MRI-safe bore covering
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2016to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children < 7 years of age.
- Undergoing medically necessary cardiovascular MRI under general anesthesia
Who cannot join
- 1.Patients with fever (temperature >38.5 degrees Celsius) or condition which require active cooling at the time of MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Patients under deep sedation and general anesthesia lose heat to their surrounding environment. Hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular complications. Cardiac MRI scans performed for patients who require general anesthesia can cause a loss of body heat.
Several mechanisms exist for reducing hypothermia under anesthesia including forced air warmers, fluid warmers, radiant warmers, and chemical warmers. Unfortunately, there are no MRI-compatible systems which allow patient warming and prevention of hypothermia in anesthetized patient in the MRI-scanner.
This study is testing a non-invasive device that warms patients under clinically indicated general anesthesia in the MRI scanner. This device will keep in the heat made by the MRI scanner.
Read the detailed description
- Each group will receive the usual clinical care for having an MRI under general anesthesia:
- General anesthesia. The type of anesthesia used will be determined by the individual anesthesiologist, and will be the safest technique possible to allow for the desired MRI images to be obtained.
- All participants will be covered with 1-2 warm blankets before receiving anesthesia and while in the scanner as part of standard warming measures.
- All participants will have continuous temperature monitoring during the scan.
- Participants will be randomized to one of the three
- 20 subjects will receive the standard of care which is 1-2 warm blankets. This group is called the control group.
- 20 study subjects will have the MRI-safe bore covering applied. This includes a clear covering sheet positioned over the openings of the MRI scanner.
- 20 study subjects will have the MRI-safe bore covering applied, and in addition one opening of the covering sheet will be connected to a "Bair hugger" ( an approved device which blows warm air). The second opening will act as a vent to let air out of the MRI scanner bore. The Bair hugger will be programmed to deliver forced air at 38 degrees Celsius (approximately 100 degrees Fahrenheit) into the contained space within the MRI scanner.
Body temperature will be monitored continuously and documented in the electronic anesthesia record. The temperature of the forced air will be adjusted to maintain a goal body temperature of 36-38 degrees Celsius (96.8- 100.4 degrees Fahrenheit).
Image quality will be evaluated by the MRI-technologist and MRI -cardiologist subjectively.
- Conditions
- Anesthesia; Hypothermia, Congenital Heart Disease
- Being tested
- MRI-safe bore covering
- Keywords
- anesthesia, MRI, thermoregulation
- Medical subject headings
- Hypothermia, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-safe bore coveringDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Patients will receive standard of care which is 1-2 warm blankets. |
| MRI-safe warming device | Experimental | The MRI-safe bore covering consists of a clear covering sheet positioned over the openings of the MRI scanner. Receives: Device: MRI-safe bore covering |
| MRI-safe warming device and Bair hugger | Experimental | IN addition to positioning the MRI-safe bore covering over the opening of the MRI scanner, the opening of the covering sheet will be connected to a device which blows warm air called a Bair Hugger. The Bair Hugger is an approved device, and MRI safe. Receives: Device: MRI-safe bore covering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normothermia maintenance using the MRI safe warming device
Body temperature will be monitored by either an esophageal stethoscope if patient is intubated or axillary temperature probe in patients who will undergo anesthesia without the need for an endotracheal tube. Temperature will be taken prior to being intubated or start of sedation, every 15 minutes, and at end of procedure when patient has returned to the recovery room.
Measured: 15 minutes
Secondary outcomes (1)
Quality of MRI images when using the MRI safe warming device
Images will be subjectively evaluated by the MRI technologist and MRI cardiologist for clarity.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start26 May 2016
- Primary completion1 May 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; HypothermiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Matisoff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Matisoff, Children's National Research Institute
- Investigators
- Andrew Matisoff, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150953
- Sponsor's protocol ID
- 6559
- Status last verified
- Mar 2019
- First submitted
- 10 May 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diaz M, Becker DE. Thermoregulation: physiological and clinical considerations during sedation and general anesthesia. Anesth Prog. 2010 Spring;57(1):25-32; quiz 33-4. doi: 10.2344/0003-3006-57.1.25.
PubMed 20331336Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.
PubMed 19137808Manning W, Pennell D. Cardiovascular magnetic resonance. London: Churchill Livingstone; 2002.
Balaban RS, Faranesh AZ, Hansen MS, Lederman RJ, Ratnayaka K. MRI scanner to infant incubator kit. Assignee: NIH. Provisional filed 2013. Tracking number: E-026-2013/0-US-01. Patent
Kellman P, McVeigh ER. Image reconstruction in SNR units: a general method for SNR measurement. Magn Reson Med. 2005 Dec;54(6):1439-47. doi: 10.1002/mrm.20713.
PubMed 16261576
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Patient Warming System During MRI
- ClinicalTrials.gov ID
- NCT03150953
- Acronym / sponsor ID
- 6559
- Conditions
- Anesthesia; Hypothermia, Congenital Heart Disease
- Keywords
- anesthesia, MRI, thermoregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Andrew MatisoffUniversity, hospital or other
- Study start
- 26 May 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients under deep sedation and general anesthesia lose heat to their surrounding environment. Hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular complications. Cardiac MRI scans performed for patients who require general anesthesia can cause a loss of body heat.
Several mechanisms exist for reducing hypothermia under anesthesia including forced air warmers, fluid warmers, radiant warmers, and chemical warmers. Unfortunately, there are no MRI-compatible systems which allow patient warming and prevention of hypothermia in anesthetized patient in the MRI-scanner.
This study is testing a non-invasive device that warms patients under clinically indicated general anesthesia in the MRI scanner. This device will keep in the heat made by the MRI scanner.
Detailed description
- Each group will receive the usual clinical care for having an MRI under general anesthesia:
- General anesthesia. The type of anesthesia used will be determined by the individual anesthesiologist, and will be the safest technique possible to allow for the desired MRI images to be obtained.
- All participants will be covered with 1-2 warm blankets before receiving anesthesia and while in the scanner as part of standard warming measures.
- All participants will have continuous temperature monitoring during the scan.
- Participants will be randomized to one of the three
- 20 subjects will receive the standard of care which is 1-2 warm blankets. This group is called the control group.
- 20 study subjects will have the MRI-safe bore covering applied. This includes a clear covering sheet positioned over the openings of the MRI scanner.
- 20 study subjects will have the MRI-safe bore covering applied, and in addition one opening of the covering sheet will be connected to a "Bair hugger" ( an approved device which blows warm air). The second opening will act as a vent to let air out of the MRI scanner bore. The Bair hugger will be programmed to deliver forced air at 38 degrees Celsius (approximately 100 degrees Fahrenheit) into the contained space within the MRI scanner.
Body temperature will be monitored continuously and documented in the electronic anesthesia record. The temperature of the forced air will be adjusted to maintain a goal body temperature of 36-38 degrees Celsius (96.8- 100.4 degrees Fahrenheit).
Image quality will be evaluated by the MRI-technologist and MRI -cardiologist subjectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Patients will receive standard of care which is 1-2 warm blankets. |
| MRI-safe warming device | Experimental | Device: MRI-safe bore coveringThe MRI-safe bore covering consists of a clear covering sheet positioned over the openings of the MRI scanner. |
| MRI-safe warming device and Bair hugger | Experimental | Device: MRI-safe bore coveringIN addition to positioning the MRI-safe bore covering over the opening of the MRI scanner, the opening of the covering sheet will be connected to a device which blows warm air called a Bair Hugger. The Bair Hugger is an approved device, and MRI safe. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children < 7 years of age.
- Undergoing medically necessary cardiovascular MRI under general anesthesia
Key exclusion criteria (1 listed)
- 1.Patients with fever (temperature >38.5 degrees Celsius) or condition which require active cooling at the time of MRI
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 |
|---|---|---|
| MRI-safe bore covering | Device | MRI-safe warming device, MRI-safe warming device and Bair hugger |
Primary outcome
Normothermia maintenance using the MRI safe warming device
Time frame: 15 minutes
Body temperature will be monitored by either an esophageal stethoscope if patient is intubated or axillary temperature probe in patients who will undergo anesthesia without the need for an endotracheal tube. Temperature will be taken prior to being intubated or start of sedation, every 15 minutes, and at end of procedure when patient has returned to the recovery room.
1 secondary outcome
Quality of MRI images when using the MRI safe warming device
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Background: PubMed 20331336Diaz M, Becker DE. Thermoregulation: physiological and clinical considerations during sedation and general anesthesia. Anesth Prog. 2010 Spring;57(1):25-32; quiz 33-4. doi: 10.2344/0003-3006-57.1.25.
- Background: PubMed 19137808Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.
- BackgroundManning W, Pennell D. Cardiovascular magnetic resonance. London: Churchill Livingstone; 2002.
- BackgroundBalaban RS, Faranesh AZ, Hansen MS, Lederman RJ, Ratnayaka K. MRI scanner to infant incubator kit. Assignee: NIH. Provisional filed 2013. Tracking number: E-026-2013/0-US-01. Patent
- Background: PubMed 16261576Kellman P, McVeigh ER. Image reconstruction in SNR units: a general method for SNR measurement. Magn Reson Med. 2005 Dec;54(6):1439-47. doi: 10.1002/mrm.20713.
- Individual participant dataSharing planned: No
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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.
Andrew Matisoff, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-safe bore covering in people with Anesthesia; Hypothermia and Congenital Heart Disease, run by Andrew Matisoff 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 1 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 28 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Normothermia maintenance using the MRI safe warming device (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150953, which also lists 5 linked publications.
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 28 Mar 2019.