Evaluation of a Novel Patient Warming System During MRI

NCT ID: NCT03150953

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-26
• Study Completion Date: 2018-11-30

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.

Conditions

Anesthesia; Hypothermia; Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care

Patients will receive standard of care which is 1-2 warm blankets.

Group Type: NO_INTERVENTION

No interventions assigned to this group

MRI-safe warming device

The MRI-safe bore covering consists of a clear covering sheet positioned over the openings of the MRI scanner.

Group Type: EXPERIMENTAL

MRI-safe bore covering

Intervention Type: DEVICE

MRI-safe warming device and Bair hugger

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.

Group Type: EXPERIMENTAL

MRI-safe bore covering

Intervention Type: DEVICE

Interventions

MRI-safe bore covering

Intervention Type: DEVICE

Eligibility Criteria

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

• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrew Matisoff

OTHER

Sponsor Role: lead

Responsible Party

Andrew Matisoff

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew Matisoff, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Children's National Health System

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20331336 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19137808 (View on PubMed)

Manning W, Pennell D. Cardiovascular magnetic resonance. London: Churchill Livingstone; 2002.

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 16261576 (View on PubMed)

Other Identifiers

6559

Identifier Type: -

Identifier Source: org_study_id