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Evaluation of a Novel Patient Warming System During MRI

Primary Purpose

Anesthesia; Hypothermia, Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI-safe bore covering
Sponsored by
Andrew Matisoff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia; Hypothermia focused on measuring anesthesia, MRI, thermoregulation

Eligibility Criteria

undefined - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's National Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard of Care

MRI-safe warming device

MRI-safe warming device and Bair hugger

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 10, 2017
Last Updated
March 26, 2019
Sponsor
Andrew Matisoff
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1. Study Identification

Unique Protocol Identification Number
NCT03150953
Brief Title
Evaluation of a Novel Patient Warming System During MRI
Official Title
Evaluation of a Novel Patient Warming System During MRI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Matisoff

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Hypothermia, Congenital Heart Disease
Keywords
anesthesia, MRI, thermoregulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients will receive standard of care which is 1-2 warm blankets.
Arm Title
MRI-safe warming device
Arm Type
Experimental
Arm Description
The MRI-safe bore covering consists of a clear covering sheet positioned over the openings of the MRI scanner.
Arm Title
MRI-safe warming device and Bair hugger
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MRI-safe bore covering
Primary Outcome Measure Information:
Title
Normothermia maintenance using the MRI safe warming device
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Quality of MRI images when using the MRI safe warming device
Description
Images will be subjectively evaluated by the MRI technologist and MRI cardiologist for clarity.
Time Frame
90 minutes

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Matisoff, MD
Organizational Affiliation
Children's National Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20331336
Citation
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.
Results Reference
background
PubMed Identifier
19137808
Citation
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.
Results Reference
background
Citation
Manning W, Pennell D. Cardiovascular magnetic resonance. London: Churchill Livingstone; 2002.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
16261576
Citation
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. Erratum In: Magn Reson Med. 2007 Jul;58(1):211-2.
Results Reference
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Evaluation of a Novel Patient Warming System During MRI

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