Back to resultsLow-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation
Primary Purpose
Feasibility and Safety of a Low-field MRI, Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperfine
Sponsored by
About this trial
This is an interventional device feasibility trial for Feasibility and Safety of a Low-field MRI
Eligibility Criteria
Inclusion Criteria Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit at Children's Mercy Kansas City Ages 0-17 years Undergoing venovenous or venoarterial ECMO Exclusion Criteria Pregnancy Active implants such as: Pacemaker Implanted defibrillator Implanted insulin pump Deep brain stimulator Vagus nerve stimulator Cochlear implant Programmable shunt MRI incompatible surgical hardware (e.g., staples, screws, etc.) Metal-containing tattoos or permanent make-up on head or neck Suspected metal in eye, e.g., Former or current welders, metal workers, or individuals with a metal injury Metal shrapnel Passive implants are considered MRI conditional
Sites / Locations
- Children's Mercy Kansas CityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Portable MRI Arm
Arm Description
All subjects enrolled with be assigned to Arm 1
Outcomes
Primary Outcome Measures
Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients
Measuring the occurrence of adverse events and serious adverse events that occurring during the portable MRI procedure. Adverse events and serious adverse events include (change in mean arterial pressure by 20% increase or decreased measured by the meters of mercury as identified by catheter measurement in patient, a decrease in the ECMO flow rate by 20% measured in milliliters per min by the ECMO machine, decrease in the oxygen saturation by 10% measured by pulse oximetry, dislodgement of the ECMO cannula measured by the occurrence of hemorrhage, as identified by PI).
Assessing the time needed to conduct a portable MRI with ECMO patients.
The analyses will examine the amount of time it takes to conduct a Portable MRI with ECMO patients. The examination records the amount of time to prep and move the patient to the portable MRI and back from the portable MRI. Preparation and movement of patient will be measured using a stopwatch identifying the number of minuets passed. The amount of time it takes to conduct the portable MRI with ECMO patients will also be analyzed. The time the MRI takes will be measured using a stopwatch examining the number of minuets passed.
Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.
The analysis will examine the number of staff needed to prep and use a portable MRI with patients. Number of staff needed will be record in RedCap via head count.
Determine the number of critical care therapies conducted during imaging studies.
Analyzing the number of critical therapies conducted during patient prep, during intervention, and post intervention. The study will record in RedCap the number of critical care therapies identified by study coordinator and PI by counting the number of therapies. Critical care therapies include (EEG, mechanical ventilation, continuous renal replacement therapy, continuous IV infusions, temporary pacing wires).
Secondary Outcome Measures
Full Information
NCT ID
NCT06074406
First Posted
September 4, 2023
Last Updated
October 7, 2023
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT06074406
Brief Title
Low-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation
Official Title
Low-Field Bedside Magnetic Resonance Imaging for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
The primary object of the study is to further characterize safety and feasibility of low-field bedside MRI in pediatric and neonatal ECMO patients. To perform imaging assessments of an early-stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength. Collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; Collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. Generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feasibility and Safety of a Low-field MRI, Acute Brain Injury, Extracorporeal Membrane Oxygenation Complication
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Portable MRI Arm
Arm Type
Experimental
Arm Description
All subjects enrolled with be assigned to Arm 1
Intervention Type
Device
Intervention Name(s)
Hyperfine
Intervention Description
Enrolled subjects will undergo a Hyperfine MRI exam, which is a portable, low-field MRI, at various timepoints during their clinical course on ECMO
Primary Outcome Measure Information:
Title
Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients
Description
Measuring the occurrence of adverse events and serious adverse events that occurring during the portable MRI procedure. Adverse events and serious adverse events include (change in mean arterial pressure by 20% increase or decreased measured by the meters of mercury as identified by catheter measurement in patient, a decrease in the ECMO flow rate by 20% measured in milliliters per min by the ECMO machine, decrease in the oxygen saturation by 10% measured by pulse oximetry, dislodgement of the ECMO cannula measured by the occurrence of hemorrhage, as identified by PI).
Time Frame
During Intervention, and immediately after intervention.
Title
Assessing the time needed to conduct a portable MRI with ECMO patients.
Description
The analyses will examine the amount of time it takes to conduct a Portable MRI with ECMO patients. The examination records the amount of time to prep and move the patient to the portable MRI and back from the portable MRI. Preparation and movement of patient will be measured using a stopwatch identifying the number of minuets passed. The amount of time it takes to conduct the portable MRI with ECMO patients will also be analyzed. The time the MRI takes will be measured using a stopwatch examining the number of minuets passed.
Time Frame
Pre intervention during patient prep, and during intervention, and immediately intervention.
Title
Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.
Description
The analysis will examine the number of staff needed to prep and use a portable MRI with patients. Number of staff needed will be record in RedCap via head count.
Time Frame
Pre intervention, during intervention, and immediately after intervention.
Title
Determine the number of critical care therapies conducted during imaging studies.
Description
Analyzing the number of critical therapies conducted during patient prep, during intervention, and post intervention. The study will record in RedCap the number of critical care therapies identified by study coordinator and PI by counting the number of therapies. Critical care therapies include (EEG, mechanical ventilation, continuous renal replacement therapy, continuous IV infusions, temporary pacing wires).
Time Frame
Pre intervention during patient prep, during intervention, and immediately after intervention.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Subjects admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit at Children's Mercy Kansas City
Ages 0-17 years
Undergoing venovenous or venoarterial ECMO Exclusion Criteria
Pregnancy
Active implants such as:
Pacemaker
Implanted defibrillator
Implanted insulin pump
Deep brain stimulator
Vagus nerve stimulator
Cochlear implant
Programmable shunt
MRI incompatible surgical hardware (e.g., staples, screws, etc.)
Metal-containing tattoos or permanent make-up on head or neck
Suspected metal in eye, e.g.,
Former or current welders, metal workers, or individuals with a metal injury
Metal shrapnel
Passive implants are considered MRI conditional
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maura Sien, RT(R)
Phone
8163018311
Email
mesien@cmh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Wallisch, MD
Organizational Affiliation
Children's Mercy Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura Sien, RT(R)
Phone
816-301-8311
Email
mesien@cmh.edu
First Name & Middle Initial & Last Name & Degree
Jessica Wallisch, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Low-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation
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