Effect of Oscillating Positive Expiratory Pressure Therapy on the Frequency of Pulmonary Atelectasis in Thoracic Cancer Patients Undergoing Chest Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Reduction of lung atelectasis
研究概览
简要总结
This randomized clinical study aims to assess the use of an oscillating positive expiratory pressure device (AEROBIKA) in patients with thoracic neoplasms who undergo chest surgery.
The main questions it aims to answer are:
If the use of the AEROBIKA device reduces the incidence of atelectasis in oncological patients undergoing lung resection.
If the use of the AEROBIKA device reduces hospital readmission and days of hospital stay.
Participants who accept to participate will be sorted to receive a conventional rehab therapy (group A), otherwise a conventional rehab therapy plus AEROBIKA device (group B).
Researchers will compare patients from group A versus group B to see if patients develop atelectasis.
详细描述
Clinical evaluation
- At patients´ first visit, demographic, clinical, and imaging variables will be obtained from INCan medical history and electronic record.
- The patient will be called one week before the date of surgery to the Pulmonary Rehabilitation service. Evaluation of lung function will be carried out through tests by means of spirometry, oscilometry, gas exchange with oxygen saturation measurement and a submaximal exercise test which is the 6 minute walk. Tests will be performed at the following times: before surgery (basal) and after surgery (one month, 2 months and 3 months).
- The EORTC, QLQ-C30 and QLQ LC13 quality of life questionnaires and a respiratory symptom questionnaire, St. George, will be performed at the same time (before surgery and after surgery (per month, 2 months and 3 months).
- Patients will be referred to the Lung Rehabilitation Service and a respiratory rehabilitation programme will be initiated. All patients, regardless of the assigned group will carry out a conventional rehabilitation program which consists of TWO PHASES (Pre-surgical Rehabilitation and Post-surgical Rehabilitation).
INTERVENTION GROUP
- At the first visit to the Pulmonary Rehabilitation service, the patient in the intervention group will receive an AEROBIKA device, at no cost, which the patient can take home.
- The patient will be instructed on the use of the device by the lung rehabilitation service and knowledge will be reinforced at each visit.
- The patient will place the date and time of use to assess adherence to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of lung cancer, mediastinal tumors or mesothelioma who are candidates for surgical resection through thoracotomy or sternotomy.
- •Measurable disease
- •Age from 18 to 75 years
- •Peak Expiratory flow of 10 liters/min
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Karnofsky score 70-100
- •Patients willing and able to comply with all study procedures and follow-up visits.
- •Patients who agree to participate and sign an informed consent form
排除标准
- •Unstable systemic disease, including active infection, cardiac or hemodynamic diseases or neurological diseases.
- •Patients with cognitive impairment who are not able to perform the pulmonary rehabilitation exercises.
- •Oral cavity or facial trauma.
- •Esophagus surgery
- •Active hemoptysis
- •Tympanic rupture or middle ear pathology.
结局指标
主要结局
Reduction of lung atelectasis
时间窗: Radiographs will be taken after 3 months of surgery
The reduction of atelectasis will be assessed according to a visual examination of thoracic radiography. In radiography, it is defined as a reduction of lung volume accompanied by an increase in opacity (radiography) or attenuation (CT) in the affected portion of the lung. Atelectasis is often associated with displacement of the cisura, bronchi, vessels, diaphragm, heart, or mediastinum. The distribution can be lobar, segmental, or subsegmental. They are classified: as linear, discoid, or platellary.
次要结局
未报告次要终点
研究者
Oscar Gerardo Arrieta Rodríguez
Coordinator of the Thoracic Oncology Unit
Instituto Nacional de Cancerologia de Mexico