Conventional Magnetic Resonance Imaging, Patient Satisfaction, Portable Magnetic Resonance Imaging
Conditions
Keywords
Brain MRI
Brief summary
This study will compare the time it takes to scan a patient in the emergency department with a portable MRI when compared to a conventional MRI. Participants will be randomized to receive a portable MRI plus standard of care (SOC) vs SOC. Investigators will look at time to beginning of scan for both.
Detailed description
The primary objective of this study is to determine whether portable brain MRI reduces the time from scan order to scan start in the emergency department as compared to conventional brain MRI. The secondary objectives of this study are 1) to measure the percentage of scans that are completed after order and the time from order to completion, 2) to compare findings on portable MRI to conventional brain imaging findings, 3) to compare the total length of stay between the portable MRI and conventional MRI groups, and 4) to understand the impact of portable MRI scans on decision making and provider satisfaction based on qualitative surveys administered to a physician endpoint panel. This is a prospective, observational, randomized study. Participants will be recruited from the pool of patients ordered for a brain MRI, with or without contrast and excluding hyperacute MRI, in the emergency department. Participants will be randomized to one of two treatment groups, scan or standard-of-care (SOC). Participants in the scan arm will receive a portable MRI scan as soon as the scanner is available after randomization. Participants in the SOC arm will not receive a portable MRI scan as part of their initial evaluation. Regardless of randomization arm, all participants will receive their scheduled conventional MRI as usual. Information on each participant's clinical course, conventional imaging, and length of stay will be collected, regardless of treatment group. On a rolling basis, surveys containing deidentified clinical information and portable MRI scans will be administered to a physician panel to assess the impact of portable MRI scans on decision making and provider satisfaction.
Interventions
DEVICESwoop Plus Mk2.0
portable brain MRI scanner
Sponsors
Yale University
Hyperfine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years of age at presentation to Yale New Haven Hospital Adult ED * Order to receive conventional brain MRI imaging originating in the YNHH Adult ED
Exclusion criteria
* Lack of assent from treating physician for inclusion in this protocol. * Contraindications to 1.5T MRI evaluation, including: 1. Cardiac Pacemaker or defibrillator 2. Aneurysm clip 3. Implants or devices attached to the body in the chest or above, such as: 1. Nerve stimulator 2. Deep brain stimulator 3. Programmable shunt 4. Stent 5. Pain pump 6. Artificial extremity 4. Implants in the ears (hearing aid or cochlear implant 5. Any shrapnel, pellets, bullets, metallic fragments, or other metallic foreign body above the chest 6. Metallic joints, rods, screws, or other orthopedic implants in or above the chest 7. Braces, dentures, removable teeth, or dental expanders that cannot be removed. 8. Body piercings in or above the chest that cannot be removed. 9. MRI-incompatible Tracheostomy tube or Swan Ganz catheter in place 10. Status Epilepticus or anyone previously seizing deemed by the physician not to be suitable for pMRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to start of scan | immediately post MRI (Day 1) | The primary outcome is time from MRI order to assigned arm scan initiation, analyzed as cumulative initiation at the prespecified time points of 3,6,9, and 12 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Portable MRI Findings | immediately post MRI (Day 1) | The frequency of acute findings (e.g., ischemic stroke, intracranial hemorrhage) using the portable MRI will be compared between groups. |
| Length of Stay | immediately post MRI (Day 1) | Total Emergency Department length of stay |
| Non-Completed Scans | immediately post missed MRI (Day 1) | To document the reasons for non-completion of MRI scans |
| Time to scan during hospital encounter | immediately post MRI (Day 1) | Time in hours from MRI order to scan initiation among participants whose assigned examination was initiated during the same hospital encounter. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdam de Havenon, MD
Yale University
Outcome results
None listed