Evaluation of a Novel Patient Warming System During MRI

Status Completed

Clinical 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. 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03150953
Study type	Interventional
Source	Children's Research Institute
Contact
Status	Completed
Phase	N/A
Start date	May 26, 2016
Completion date	November 30, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT04992793` - Paediatric Brain Injury Following Cardiac Interventions
Recruiting	`NCT05213598` - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed	`NCT04136379` - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed	`NCT04814888` - 3D Airway Model for Pediatric Patients
Recruiting	`NCT04920643` - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery	N/A
Completed	`NCT05934578` - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training	N/A
Recruiting	`NCT06041685` - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia	N/A
Recruiting	`NCT05902013` - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation	N/A
Not yet recruiting	`NCT05687292` - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting	`NCT05524324` - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT	N/A
Completed	`NCT02746029` - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed	`NCT02537392` - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease	N/A
Completed	`NCT03119090` - Fontan Imaging Biomarkers (FIB) Study
Recruiting	`NCT02258724` - Swiss National Registry of Grown up Congenital Heart Disease Patients
Completed	`NCT01966237` - Milrinone Pharmacokinetics and Acute Kidney Injury
Terminated	`NCT02046135` - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery	Phase 2
Recruiting	`NCT01184404` - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery	N/A
Completed	`NCT01548950` - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension	N/A
Completed	`NCT01821287` - Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.