Feasibility and benefits of an oscillatory negative-pressure device for secretion mobilization in patients hospitalized with acute COPD exacerbation - a randomized controlled trial
Patients hospitalized with acute exacerbation of COPD
Participants will be recruited by the attending physician in collaboration with a physiatrist, who confirmed the indication for respiratory rehabilitation. An initial interview will be conducted by one of the investigators to verify eligibility criteria and obtain written informed consent. After consent is obtained, the baseline assessment (Assessment 0) will be performed and recorded in the Case Report Form. In this first assessment, demographic data, clinical history and clinical evaluation (Vital signs, respiratory simptoms, CAT, Leicester acute) will be registered. Participants will then be randomized to either the intervention group or the control group using appropriate randomization software (Randomizer®) making a computer-generated allocation sequence. The control group will receive conventional respiratory physiotherapy (breathing retraining, controlled inspiratory slow breathing, Slow open glottis expirations, huffing and cough) combined with a sham procedure using the Semiox® device, while the intervention group will reveive similar respiratory physiotherapy combined with the Semiox® oscillatory negative-pressure device. Interventions will be carried out once a day by the principal investigator, an experienced physiotherapist, with the agreement of the attending physician.
1. Patient with confirmed diagnosis of COPD 2. Hospitalized with respiratory onset 3. With an increase of his usual secretion production
1. Hemodynamic instability requiring vasopressor support 2. Severe respiratory failure defined as PaO₂/FiO₂ < 100 3. Respiratory failure requiring a fraction of inspired oxygen (FiO₂) > 60% 4. Altered level of consciousness or inability to cooperate with the intervention 5. Untreated or undrained pneumothorax 6. Massive hemoptysis 7. Unstable cardiovascular disease (e.g., acute coronary syndrome, uncontrolled arrhythmias) 8. Any clinical condition requiring strict bed rest or contraindicating participation in respiratory physiotherapy