Yale New Haven Health Emergency Department
New Haven, Connecticut, 06520, United States
NCT Number: NCT06930534
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
portable brain MRI scanner
Time frame: 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.
Time frame: 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.
Time frame: immediately post MRI (Day 1)
Total Emergency Department length of stay
Time frame: immediately post missed MRI (Day 1)
To document the reasons for non-completion of MRI scans
Time frame: 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.
Yale University
Other
Acronym: PRIME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05613439
Ambulatory Surgical Procedures, Behavior
Copenhagen, Capital Region, Denmark
View Trial DetailsNCT06506669
Anesthesia, Behavior
San Francisco, California, United States
View Trial DetailsNCT01052415
Behavior, HIV-related Stigma
Los Angeles, California, United States
View Trial DetailsNCT06458647
Anxiety, Anxiety Disorders
Talas, Kayseri, Turkey (Türkiye)
View Trial Details