Portable Rapid Imaging for Medical Emergencies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time to start of scan
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Lack of assent from treating physician for inclusion in this protocol.
- •Contraindications to 1.5T MRI evaluation, including:
- •Cardiac Pacemaker or defibrillator
- •Aneurysm clip
- •Implants or devices attached to the body in the chest or above, such as:
- •Nerve stimulator
- •Deep brain stimulator
- •Programmable shunt
- •Artificial extremity
- •Implants in the ears (hearing aid or cochlear implant
- •Any shrapnel, pellets, bullets, metallic fragments, or other metallic foreign body above the chest
- •Metallic joints, rods, screws, or other orthopedic implants in or above the chest
- •Braces, dentures, removable teeth, or dental expanders that cannot be removed.
- •Body piercings in or above the chest that cannot be removed.
- •MRI-incompatible Tracheostomy tube or Swan Ganz catheter in place
- •Status Epilepticus or anyone previously seizing deemed by the physician not to be suitable for pMRI
研究组 & 干预措施
Portable Brain MRI scan
Participants in the scan arm will receive a portable MRI scan as soon as the scanner is available after randomization as part of their initial evaluation. Regardless of randomization arm, all participants will receive their scheduled conventional MRI as usual.
干预措施: Swoop Plus Mk2.0 (Device)
Standard of Care
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.
结局指标
主要结局
Time to start of scan
时间窗: 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.
次要结局
- Percentage of Completed Scans(immediately post MRI (Day 1))
- Portable MRI Findings(immediately post MRI (Day 1))
- Provider Satisfaction Survey(immediately post MRI (Day 1))
- Percentage of Completed Scans(immediately post MRI (Day 1))
- Portable MRI Findings(immediately post MRI (Day 1))
- Provider Satisfaction Survey(immediately post MRI (Day 1))
- Non-Completed Scans(immediately post missed MRI (Day 1))
- Length of Stay(immediately post MRI (Day 1))
