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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.
A. Each group will receive the usual clinical care for having an MRI under general anesthesia:
B. Participants will be randomized to one of the three
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI-safe bore covering | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 minutes |
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Inclusion Criteria:
Exclusion Criteria:
1.Patients with fever (temperature >38.5 degrees Celsius) or condition which require active cooling at the time of MRI
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Matisoff, MD | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Health System | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20331336 | Background | 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. | |
| 19137808 | Background | Reynolds 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. |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018376 | Cardiovascular Abnormalities |
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| Background | Manning W, Pennell D. Cardiovascular magnetic resonance. London: Churchill Livingstone; 2002. |
| Background | 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 |
| 16261576 | Background | 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. |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |