Low-Field Bedside Brain Magnetic Resonance Imaging in Pediatric Extracorporeal Membrane Oxygenation

Not Applicable

Active, not recruiting

• Conditions: Acute Brain Injury; Feasibility and Safety of a Low-field MRI; Extracorporeal Membrane Oxygenation Complication
• Interventions: Device: Hyperfine

• Registration Number: NCT06074406
• Lead Sponsor: Children's Mercy Hospital Kansas City

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-10-07
• Study First Posted: 2023-10-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Portable MRI Arm	Hyperfine	All subjects enrolled with be assigned to Arm 1

Primary Outcome Measures

Name	Time	Method
Analyzing the number of staff required to conduct a Portable MRI with an ECMO patient.	Pre intervention, during intervention, and immediately after intervention.	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.
Examining the occurrence of adverse events and serious adverse events with portable MRI use in ECMO patients	During Intervention, and immediately after intervention.	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.	Pre intervention during patient prep, and during intervention, and immediately intervention.	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.
Determine the number of critical care therapies conducted during imaging studies.	Pre intervention during patient prep, during intervention, and immediately after intervention.	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).

Trial Locations

Locations (1)

Children's Mercy Kansas City; 🇺🇸 Kansas City, Missouri, United States