Changes in Respiratory Function and Chest Wall Movement Following Oesophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Lung function
研究概览
简要总结
Open surgery for esophageal cancer commonly involves large incisions in the chest, associated with a high rate of pulmonary complications (30-50%). Minimally invasive approach through keyhole surgery has been shown to reduce pulmonary infections by 20%. Enhanced recovery programmes are evidence-based protocols, developed to achieve early recovery after surgery with early mobilisation and chest physiotherapy and have been shown to reduce pulmonary complication rates as well. The investigators intend to objectively measure chest wall movement using 3D motion capture system as well as a wearable measurement system to monitor chest wall movement.
详细描述
The study population consists of 40 healthy volunteers who have not received upper gastrointestinal surgery and 60 patients treated with surgery more than one year ago (open approach). Chest wall movement will be measured using a 3D optical motion system and the investigators will establish if inertial measurement units placed strategically on the chest wall are able to quantify chest expansion and lung capacity. Data will be acquired during different breathing patterns and during use of an incentive spirometry. Pulmonary function tests will be undertaken in all patients and the investigators will also collect clinical data concerning health-related quality of life and other concomitant medical conditions. The target outcome of this study is to determine whether the 3D motion capture and wearable systems are reliable in the measurement of chest wall movement after surgical removal of esophagus and the validity and patient acceptability of wearable system, as well as the ability of distinguishing open and minimally invasive surgical approach. A tailored physiotherapy may be developed following this study in order to improve chest wall movement and objectively measure this using the wearable system. This can then be implemented in a clinical trial to provide the evidence base to for patient-tailored physiotherapy following major cancer surgery and to optimise the respiratory function.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exposure group:
- •Patients treated more than a year ago with oesophagectomy for oesophageal cancer, by an open approach.
- •Patients able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.
- •Control group:
- •Healthy volunteers with no underlying respiratory disease and no history of upper gastrointestinal surgery.
- •Individuals able to understand and retain the information provided, thereby being able to give informed consent for inclusion in this study.
排除标准
- •Any participant who lacks capacity or is unable to provide informed consent.
- •Any participant younger than 18 or older than 90 years of age.
- •Any patient with evidence of cancer recurrence or on-going postoperative complication at more than one year following surgery for oesophageal cancer.
- •Any pregnant participant.
- •unable to or excluded from performing spirometry or respiratory muscle strength testing (non-invasive testing)
结局指标
主要结局
Lung function
时间窗: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Patients will be asked to perform incentive spirometry which is a non-invasive assessment of the lung function. Spirometry (tidal breathing, forced vital capacity) and respiratory muscle strength will be recorded for all participants.
Chest wall movement
时间窗: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Evaluation of changes in chest wall movement in patients who have undergone oesophagectomy more than a year ago (open surgery) and in healthy control participants. Reflective markers will be placed on the chest wall of the participant and chest wall movement will be detected by a 3D motion capture system using these markers. In addition, inertia measurement units will be applied next to the markers. Chest wall movement will be assessed during normal breathing, take and hold a deep breath and whilst performing incentive spirometry.
Chest wall movement
时间窗: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Evaluation of changes in chest wall movement in patients who have undergone oesophagectomy more than a year ago (open surgery) and in healthy control participants. Reflective markers will be placed on the chest wall of the participant and chest wall movement will be detected by a 3D motion capture system using these markers. In addition, inertia measurement units will be applied next to the markers. Chest wall movement will be assessed during normal breathing, take and hold a deep breath and whilst performing incentive spirometry.
Lung function
时间窗: Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.
Patients will be asked to perform incentive spirometry which is a non-invasive assessment of the lung function. Spirometry (tidal breathing, forced vital capacity) and respiratory muscle strength will be recorded for all participants.
次要结局
- Health-related Quality of Life in cancer patients(Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.)
- Health-related Quality of Life in patients with tumours of the oesophagus, oesophago-gastric junction or stomach(Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.)
- Health-related Quality of Life in cancer patients(Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.)
- Health-related Quality of Life in patients with tumours of the oesophagus, oesophago-gastric junction or stomach(Each participant will undergone one assessment during the study. The whole session, all procedures included, will last approximately 60 minutes.)