Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469801
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-12
Brief Title:
ECMO ABI Detection With Hyperfine
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Low-Field Bedside MRI for Detection of Acute Brain Injury in Pediatric Extracorporeal Membrane Oxygenation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients
Detailed Description:
Extracorporeal membrane oxygenation ECMO is frequently used to treat refractory cardiovascular andor respiratory failure As the support modality has evolved survival has significantly improved yet there are high rates of acute brain injury ABI in this population due to disease patient and treatment factors This results in significant morbidity and mortality Specifically thromboembolic hypoxic-ischemic and hemorrhagic complications occur during ECMO support but the investigators are limited in the monitoring and diagnosis of ABI while on ECMO as currently available imaging modalities ie ultrasound US computed tomography CT have low sensitivity for early hypoxic cerebrovascular and ischemic brain injuries The sensitivity of these modalities increases only when it is too late to effectively intervene Standard magnetic resonance imaging MRI is the gold standard to diagnose stroke and ischemic brain injury but is incompatible with ECMO devices Swoop Hyperfine Guilford CT is an FDA cleared ultralow-field portable MRI system that can be used at the bedside and has been studied in critically ill adults with various types of ABI This novel bedside MRI has been safely operated in clinical environments with equipment that is typically not MRI compatible A few adult and pediatric ECMO patients have undergone bedside brain MRIs showing feasibility Yet what remains unknown is the true prevalence and timing of hypoxic cerebrovascular and ischemic brain injuries in pediatric ECMO
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None