Evaluation of a Novel Patient Warming System During MRI

Not Applicable

Completed

• Conditions: Anesthesia; Hypothermia; Congenital Heart Disease
• Interventions: Device: MRI-safe bore covering

• Registration Number: NCT03150953
• Lead Sponsor: Andrew Matisoff

Brief 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. 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

A. Each group will receive the usual clinical care for having an MRI under general anesthesia:

1. 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.

2. All participants will be covered with 1-2 warm blankets before receiving anesthesia and while in the scanner as part of standard warming measures.

3. All participants will have continuous temperature monitoring during the scan.

B. Participants will be randomized to one of the three

1. 20 subjects will receive the standard of care which is 1-2 warm blankets. This group is called the control group.

2. 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.

3. 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 Timeline

• Study Start: 2016-05-26
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Primary Completion: 2018-05-01
• Study Completion: 2018-11-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Children < 7 years of age.
2. Undergoing medically necessary cardiovascular MRI under general anesthesia

Exclusion Criteria

1.Patients with fever (temperature >38.5 degrees Celsius) or condition which require active cooling at the time of MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI-safe warming device	MRI-safe bore covering	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	MRI-safe bore covering	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.

Primary Outcome Measures

Name	Time	Method
Normothermia maintenance using the MRI safe warming device	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.

Secondary Outcome Measures

Name	Time	Method
Quality of MRI images when using the MRI safe warming device	90 minutes	Images will be subjectively evaluated by the MRI technologist and MRI cardiologist for clarity.

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States