NCT03150953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

May 10, 2017

Last Update Submit

March 26, 2019

Conditions

Anesthesia; HypothermiaCongenital Heart Disease

Keywords

anesthesiaMRIthermoregulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 minutes

Secondary Outcomes (1)

  • Quality of MRI images when using the MRI safe warming device

    90 minutes

Study Arms (3)

Standard of Care

NO INTERVENTION

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

MRI-safe warming device

EXPERIMENTAL

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

Device: MRI-safe bore covering

MRI-safe warming device and Bair hugger

EXPERIMENTAL

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.

Device: MRI-safe bore covering

Interventions

MRI-safe bore coveringDEVICE
MRI-safe warming deviceMRI-safe warming device and Bair hugger

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children \< 7 years of age.
  • Undergoing medically necessary cardiovascular MRI under general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Health System

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

Location

Related Publications (5)

  • 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.

    PMID: 20331336BACKGROUND

  • 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.

    PMID: 19137808BACKGROUND

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

    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

    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.

    PMID: 16261576BACKGROUND

MeSH Terms

Conditions

HypothermiaHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Andrew Matisoff, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 12, 2017

Study Start

May 26, 2016

Primary Completion

May 1, 2018

Study Completion

November 30, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)