Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis - the Prospective RAPIDLY-study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 6-minute walking distance (6MWD).
研究概览
简要总结
Diaphragmatic paralysis may lead to severe symptoms such as breathlessness and reduced physical capacity.
Diaphragmatic plication using Robotic-Assisted Thoracic Surgery (RATS) is a minimally invasive surgical technique developed to improve lung function by correcting diaphragmatic elevation.
While its benefits have been reported in retrospective reports, prospective studies are lacking.
This prospective observational cohort study aimsto evaluate the short- and long-term effects of robot-assisted diaphragmatic plication on subjective breathlessness, physical performance, lung function, blood gases, and imaging findings at five Swedish university hospitals: Gothenburg, Linköping, Lund, Umeå, and Uppsala.
Patients will be assessed preoperatively and postoperatively after one to three months and after one and three years.
详细描述
Assessments
Patient characteristics:
Age, sex, height, and weight will be recorded. Body mass index (BMI) is calculated by dividing a person's weight by their height in meters squared.
Aetiology of diaphragmatic paralysis, relevant co-morbidities and use of long-term oxygen therapy and/or mechanical ventilation will be recorded.
The date for symptom debut, if known, is recorded. Smoking history is defined as current smoker, ex-smoker (smoking history of ≥100 cigarettes and having quit smoking ≥6 months ago), and never smoker (smoking history of <100 cigarettes). Smoking is quantified by pack-years (the number of packs of cigarettes a person has smoked daily, multiplied by the number of years they have smoked).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic unilateral diaphragmatic paralysis persisting for ≥1 year
- •Patients are scheduled for RATS at thoracic surgery clinics in five Swedish university hospitals (Gothenburg, Linköping, Lund, Umeå, and Uppsala).
排除标准
- •Inability to complete forms in Swedish
- •Neuromuscular disease as the cause of diaphragmatic paralysis
- •Other significant causes of dyspnea
- •Impaired physical capacity from other causes than diaphragmatic paralysis.
结局指标
主要结局
6-minute walking distance (6MWD).
时间窗: From enrollment to end of observation att 3 years.
The patients are asked to walk as far as possible on a flat, straight surface for six minutes, and the total distance walked is measured.
次要结局
- The modified Medical Research Council (mMRC) dyspnea scale(From enrollment to end of observation att 3 years.)
- Pulse oximetry(From enrollment to end of observation att 3 years.)
- Computerised tomography (CT) of Thorax(From enrollment to end of observation att 3 years.)
- Adverse events(30 days post-operatively)
- The modified Borg Scale(From enrollment to end of observation att 3 years.)
- The Dyspnea-12 questionnaire(From enrollment to end of observation att 3 years.)
- The EQ-5D questionnaire(From enrollment to end of observation att 3 years.)
- Spirometry(From enrollment to end of observation att 3 years.)
- One-minute sit-to-stand test (1-MSTST)(From enrollment to end of observation att 3 years.)
- The Maximal Inspiratory Pressure (MIP) test(From enrollment to end of observation att 3 years.)
- Blood gas analysis(From enrollment to end of observation att 3 years.)
- Chest X-ray(From enrollment to end of observation att 3 years.)
研究者
Andreas Palm
Associate Professor
Uppsala County Council, Sweden