Continuous Monitoring of Microvascular Anastomoses: An Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility - record audible doppler signal tracings
研究概览
简要总结
This study is being done to see whether signals from a device that monitors blood flow through the free flap can be recorded and converted from an audible signal, like a heartbeat, into a visual signal. Researchers plan to use this information to ultimately help surgeons and care teams monitor free flaps to try to prevent flap failure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for free flap surgery and planned to have an implanted doppler monitor
- •Arterial Doppler waveforms available for analysis
- •Able and willing to sign consent and return for clinical follow up
- •Age ≥ 18 years
排除标准
- •Prior head and neck surgery within the region where surgeons plan to identify donor vessels ≤ 365 days prior to registration
研究组 & 干预措施
Observational
Patients undergo recording of the clinical Doppler monitor via an implanted research recording device (RRD) and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Feasibility - record audible doppler signal tracings
时间窗: Up to 30 days
Ability to record a minimum of 2 audible doppler signal tracings from the implantable doppler per 24 hours for a minimum of one 24 hour period for 80% of subjects. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed research recording device (RRD) to record and convert recorded signals into various visual formats. Recordings will be observed by study staff to determine whether auditory acuity matches expected signals.
Feasibility - convert audible doppler signal tracings to stored data files
时间窗: Up to 30 days
Ability to convert the recorded doppler signal tracings to stored data files for 80% of subjects. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed RRD to record and convert recorded signals into various visual formats.
次要结局
- Feasibility - convert audible data to visual signal to a visual signal(Up to 30 days)