Effect of Simeox® as a novel airway clearance device in the management of COPD patients with acute exacerbations: A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 43
- 试验地点
- 1
研究概览
简要总结
This prospective, randomized controlled trial will evaluate whether adding the SIMEOX airway clearance device to conventional chest physiotherapy (CPT and Simeox) improves sputum clearance and clinical outcomes compared with CPT alone in adults hospitalized with acute exacerbation of COPD (GOLD II to IV). A total of 43 participants will be randomized to the two groups and will receive supervised physiotherapy twice daily for 14 days (28 sessions). The intervention group will receive SIMEOX therapy twice daily (each SIMEOX session approximately 10 minutes consisting of three cycles of 10 breaths with 45 second breaks, using frequency settings of 12 Hz or 6 Hz as tolerated and an exhalation ramp from 100% to 25%) in addition to CPT and ACBT, while the control group will receive CPT (postural drainage, percussion, vibration) combined with ACBT performed twice daily (each session approximately 20 minutes). Baseline data including sputum volume, peak cough flow rate, dyspnea, pulmonary function tests, arterial blood gases, functional capacity, health realted quality of life, Hospital Anxiety and Depression will be collected one day before intervention and post intervention measurements will be taken one day after completion of 28 sessions of training using standardized protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults more than or equal to 18 years old with AECOPD will be considered.
- •Presence of not–fully reversible airflow limitation, with an FEV1/ FVC less than 0.7 post bronchodilation measured by spirometry.
- •COPD patients, GOLD stage II-IV Patients who are hospitalised for severe exacerbation of COPD experiencing worsening of dyspnoea, cough, and or sputum lasting up to 14 days, often accompanied by tachypnoea and tachycardia for duration less than 2 weeks.
- •Significant Sputum production.
排除标准
- •Patients that had under gone previous lung transplantation, required mechanical non-invasive ventilation for more than eight hours per day, had history of haemoptysis or pneumothorax in the last 12 months, were pregnant or breastfeeding.
- •Severe cardiac comorbidities (recent heart attack, unstable angina, uncontrolled rhythm disorders, and unstable cardiac failure) or neuromuscular disorders.
- •Patients who present with Asthma and Asthma-COPD overlap syndrome ACOS.
- •Patients who present with other respiratory conditions such as bronchiectasis, cystic fibrosis and interstitial lung diseases.
研究者
Kritika Srivastava
Jamia Millia Islamia