Evaluation of a Novel Point-of-care Percussion Device (PD) for Detection of Pneumothorax in Patients Following Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Performance metrics
研究概览
简要总结
This study aims to examine the safety and efficacy of the Percussion Device in detecting a pneumothorax in patients that have undergone thoracic surgery.
详细描述
A prospective, non-randomized clinical feasibility cohort study. The purpose of this feasibility study is to collect preliminary performance and safety information for the Percussion Device (PD). Patients satisfying the inclusion criteria will be approached for study enrolment before their surgery in clinic. Following surgery and after the patient's chest tube has been removed, evaluation of the chest using the PD and ultrasound will be performed by two independent assessors (a nurse practitioner or resident on the Thoracic Surgery Team) prior to the post-removal CXR. Details of study procedure are details in section 2.8. The PD's performance metric will be compared against CXR results, which is considered the gold standard in diagnosing a pneumothorax.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Radiologists are unaware of the intervention or the nature of the study.
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
- •All patients that have undergone an open or thoracoscopic thoracic procedure requiring a chest tube at London Health Sciences Centre (LHSC), London, Ontario.
排除标准
- •Patients less than 18 years old Patients unable to consent Patients with known persistent pneumothorax prior to chest tube removal Patients who are pregnant Patients with severe chest wall deformity.
研究组 & 干预措施
PD arm
Patients undergoing assessment of the chest with the percussion device (PD).
干预措施: Percussion Device (PD) (Device)
US arm
Patients undergoing assessment of the chest with the ultrasound (US).
干预措施: Ultrasound (US) (Device)
结局指标
主要结局
Performance metrics
时间窗: 2 years
Performance metrics of the PD in detecting the presence of a pneumothorax following the removal of the last chest tube in patients that have undergone thoracic surgery compared to the CXR reported by a blinded radiologist unaware of the study.
次要结局
- Inter-rater reliability(2 years)
- Adverse Events(2 years)
- Marginal Costs(2 years)
研究者
Richard Malthaner
Thoracic Surgeon
Lawson Health Research Institute