High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Post(SARS-CoV-2)

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Lung flute (OPEP); Device: high frequency chest wall oscillation with vest system

• Registration Number: NCT05591781
• Lead Sponsor: Cairo University

Brief Summary

COPD causes an acute deterioration of respiratory symptoms, particularly increased breathlessness and cough, and increased sputum volume and/or purulence. Worsening airflow limitation is associated with an increasing prevalence of exacerbations and risk of death. These exacerbations can range from self-limited diseases to episodes of florid respiratory failure requiring mechanical ventilation .Hospitalization for COPD patients post COVID is associated with poor prognosis with increased risk of death. Hence techniques of efficient clearance of peripheral airways may reduce airway occlusion by excess mucus and inflammatory cells, improving lung function, exercise capacity and reducing exacerbation frequency.

Detailed Description

Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application. Thirty patients (Group A) received high frequency chest wall oscillation with vest system in addition to their prescribed medication, 3 times per week for three successive weeks and the total duration of each session was 15-30 minutes. Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 2 times per week twice a day for three successive weeks and the total duration of each session was 10-15 minutes

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-10
• Primary Completion: 2022-10
• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-19
• Last Update Submitted: 2022-10-19
• Study First Posted: 2022-10-24
• Last Update Posted: 2022-10-24
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• All patients aged 40-60 years old
• All patients were recovered from COVID not more than 3 months
• All patients were diagnosed as COPD for at least two years ago.
• All patients had irreversible/ partially reversible obstruction of airflow.
• COPD patients had a post-bronchodilator, FEV1/FVC% < 70%. They had an increase in FEV1< 200 ml, or < 12% of baseline value 20 minutes after 2 puffs of inhaled salbutamol (100 µg) given via a metered-dose inhaler.

Exclusion Criteria

• Presence of malignant disease.

  • Patients with acute infection.
  • History of osteoporosis, significant gastro-oesophageal reflux, hiatus hernia.
  • Recent acute cardiac event (6 weeks) or congestive cardiac failure.
  • Any significant musculoskeletal disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung flute (OPEP)	Lung flute (OPEP)	Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 3 times per week twice a day
Vest Airway Clearance System	high frequency chest wall oscillation with vest system	Thirty patients (Group A) received high frequency chest wall oscillation with vest system in addition to their prescribed medication, 3 times per week for three successive weeks and the total duration of each session was 15-30 minutes

Primary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	Forced vital capacity (FVC)will be measured at baseline, and after three weeks.	FVC is the amount of air that can be forcibly exhaled from lungs after deepest inspiration, it's measured by spirometry
The forced mid-expiratory flow (FEF25-75%)	(FEF25-75%) will be measured at baseline, and after three weeks.	(FEF25-75) measures the average flow rates of medium-to-small airways during the forced vital capacity (FVC).it' is a potentially sensitive marker of obstructive peripheral airflow
Forced expiratory volume in one second (FEV1)	FEV1 will be measured at baseline, and after three weeks.	FEV1 is the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation
FEV1/FVC ratio	FEV1/FVC ratio will be measured at baseline, and after three weeks.	The FEV1/FVC is a ratio that reflects the amount of air you can forcefully exhale from your lungs. It's measured by spirometry, a test used to evaluate lung function

Secondary Outcome Measures

Name	Time	Method
COPD assessment test (CAT	COPD assessment test (CAT)will be measured at baseline, and after three weeks.	is a validated, short (8-item) and simple patient completed questionnaire
Six-minute walk test	6min walk test will be measured at baseline, and after three weeks.	Six-minute walk test was carried out before and after interventions to determine the patient functional capacity

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt