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

Efficacy of High Frequency Chest Wall Oscillations Versus Lung Flute in Chronic Obstructive Pulmonary Disease Postcovid

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: high frequency chest wall oscillation with vest system; Device: Lung flute (OPEP)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa El-Moatasem, lecturer; Phone Number: 01006625054; Email: alaamotasem@rocketmail.com
• Study Contact Backup: Name: Omnia Ahmed, Lecturer; Phone Number: 01227805225; Email: omsaeed@msa.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Recruiting
    • Cairo University
    • Contact: Alaa El-Moatasem, lecturer; Phone Number: 01006625054; Email: alaamotasem@rocketmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vest Airway Clearance 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	Device: high frequency chest wall oscillation with vest system; Patients were assigned to 2 groups with pre- and post- treatment protocol application. All patients were thoroughly evaluated before and after treatment protocol application.
Active Comparator: Lung flute (OPEP); Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 3 times per week twice a day	Device: Lung flute (OPEP); . Thirty patients (Group B) received Lung flute (OPEP) in addition to their prescribed medication, 3 times per week twice a day for three successive weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity (FVC)	FVC is the amount of air that can be forcibly exhaled from lungs after deepest inspiration, it's measured by spirometry	Forced vital capacity (FVC)will be measured at baseline, and after three weeks.
Forced expiratory volume in one second (FEV1)	FEV1 is the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation	FEV1 will be measured at baseline, and after three weeks.
FEV1/FVC ratio	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	FEV1/FVC ratio will be measured at baseline, and after three weeks.
The forced mid-expiratory flow (FEF25-75%)	(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	(FEF25-75%) will be measured at baseline, and after three weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: P.T.REC/012/003822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes