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OpenTrials
Completed

NCT Number: NCT03150953

Evaluation of a Novel Patient Warming System During MRI

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.

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Key information

Conditions

Anesthesia; Hypothermia Body Temperature Changes Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

About this study

A. 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.

B. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children < 7 years of age.
  • 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

Treatment and study plan

MRI-safe bore covering

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quality of MRI images when using the MRI safe warming device

    Time frame: 90 minutes

    Images will be subjectively evaluated by the MRI technologist and MRI cardiologist for clarity.

Sponsors and collaborators

Lead sponsor

Andrew Matisoff

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 12, 2017
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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