Portable Ultrasound for Interventional Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Efficacy > 80%
研究概览
简要总结
We are evaluating whether a portable ultrasound can be safely and effectively used in portable interventional procedures, whether the image quality can be improved to meet standard existing ultrasounds. In the COVID-19 pandemic, transferring patients with COVID-19 to the procedure room results in contamination and shut down of those rooms while also putting folks in transit at some degree of transmission risk. The ability to do procedures at bedside can alleviate those risks greatly.
详细描述
Portable ultrasound-guided procedures, including paracentesis, thoracentesis, drain placement, or simple biopsies can be required for patients who are difficult to move, in particular COVID-19 patients, patients in the ICU, or on the floor. Portable ultrasounds have demonstrated a convenient ability to provide a point of care ultrasound diagnostic testing with expanding use in standard clinical care. A number of portable ultrasound systems are in routine clinical use at MGH and have been used for diagnostic procedures (e.g. Butterfly, Hologic, others). Most of the systems are still tethered (transducer is connected via cables to a computer or power) which may represent challenges for contamination, especially in interventional procedures. The Healcerion system is the first FDA approved wireless and battery-operated portable ultrasound system of its kind and is in routine use for diagnostic ultrasounds throughout the world.
The goal of the current study is to compare the utility and practical operations of the advanced Healcerion SONON ultrasound system to a standard wheeled and bulky ultrasound systems in current use (Hitachi, GE). While the Healcerion device has been used at other institutions, it has not been used for interventional procedures at MGH. A comparative efficacy study will allow the investigators to examine the safety and efficacy of the device to complete procedures in a portable setting as well as explore whether images can be improved to reach the more robust imaging capability of wired devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has read, signed, and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
- •Age ≥ 18 years at the date of informed consent form signature and having the ability to comply with the protocol.
- •Undergoing a clinically indicated ultrasound-guided procedure, such as paracentesis, thoracentesis, or biopsy.
排除标准
- •Patient or health care proxy does not consent
- •Patient not undergoing an ultrasound-guided procedure.
结局指标
主要结局
Efficacy > 80%
时间窗: Approximately 3 years
Efficacy as defined by the operator in successfully completing the procedure using the portable ultrasound. Reported % of cases the portable ultrasound successfully completed the procedure, stratified by procedure type.
次要结局
未报告次要终点
研究者
Ralph Weissleder, MD
Professor
Massachusetts General Hospital
