Effects of Manual Positive End Expiratory Pressure and Non-invasive Continuous Positive Air Pressure in COPD Patients

Not Applicable

Not yet recruiting

• Conditions: COPD

• Registration Number: NCT07079527
• Lead Sponsor: Riphah International University

Brief Summary

This randomized clinical trial aims to compare the effectiveness of Manual Positive End Expiratory Pressure (PEEP) and Non-Invasive Continuous Positive Airway Pressure (CPAP) in patients with Chronic Obstructive Pulmonary Disease (COPD). A total of 42 patients will be randomly assigned to two groups: one receiving manual PEEP therapy and the other receiving CPAP therapy, over a 4-week period. The primary goal is to assess and compare improvements in respiratory rate, oxygen saturation (SpO₂), and patient-reported breathlessness and comfort using standardized tools such as pulse oximetry, digital spirometry, the Borg dyspnea scale, and the COPD Assessment Test. The study is designed as a single-blind randomized trial and will be conducted at Imran Idrees and Allama Iqbal Memorial Hospitals in Sialkot. The outcomes are expected to guide better non-invasive management strategies for COPD patients to enhance clinical outcomes and quality of life.

Detailed Description

This randomized clinical trial investigates the comparative effectiveness of Manual Positive End Expiratory Pressure (PEEP) and Non-Invasive Continuous Positive Airway Pressure (CPAP) in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a progressive respiratory condition characterized by airflow limitation, leading to breathlessness, decreased exercise tolerance, and frequent hospitalizations. Non-invasive ventilation techniques such as PEEP and CPAP are widely used to manage respiratory symptoms and improve lung function in these patients, but direct comparisons of their efficacy remain limited.

A total of 42 patients with Stage 3 or 4 COPD, aged over 40 years, will be enrolled and randomly assigned to two groups:

Group A will receive manual PEEP therapy

Group B will receive non-invasive CPAP therapy

The intervention will last four weeks, and all patients will receive baseline treatment in the form of Active Cycle of Breathing Techniques (ACBTs). The study will be conducted at Imran Idrees Teaching Hospital and Allama Iqbal Memorial Hospital, Sialkot.

Primary outcome measures include improvements in:

Oxygen saturation (SpO₂)

Respiratory rate

Patient-reported breathlessness (using the Borg scale)

Quality of life and symptom severity (using the COPD Assessment Test)

Data collection tools include pulse oximetry, digital spirometry (for FEV₁, FVC, PEF), and standardized questionnaires. The study uses a single-blind design, where the assessor is blinded to the group allocation.

The purpose is to determine which intervention-manual PEEP or CPAP-offers superior clinical outcomes, patient comfort, and symptom relief. Findings from this research aim to support evidence-based decision-making for non-invasive COPD management in clinical settings.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Study Start: 2025-07-28
• Primary Completion: 2025-11-28
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age>40years old
• SevereCOPDpatients with Stage 3 & 4 according to Gold Criteria
• Notcurrently experiencing an acute exacerbation.
• Baseline Forced Expiratory Volume in 1 second (FEV1) < 70% of predicted
• Ability to provide informed consent.

Exclusion Criteria

• Othersignificant respiratory diseases (e.g., asthma, pulmonary fibrosis, cystic fibrosis)
• Invasive mechanical ventilation
• Pregnant or Breastfeeding women
• Cardiac arrhythmias or instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in SpO₂ (Oxygen Saturation) from Baseline to Post-Intervention	4 weeks	Oxygen saturation (%) will be measured using a pulse oximeter before and after the 4-week intervention. The average change in SpO₂ will be compared within and between both groups.
Change in Respiratory Rate (RR) from Baseline to Post-Intervention	4 weeks	Respiratory rate (breaths per minute) will be recorded at baseline and after 4 weeks. Lower respiratory rate post-intervention reflects clinical improvement.
Borg Dyspnea Scale Score from Baseline to Post-Intervention at 4 weeks	4 weeks	The Borg Dyspnea Scale, a 0-10 point subjective scale, will be used to evaluate the severity of dyspnea in COPD patients. A score of 0 represents no breathlessness, and a score of 10 represents maximal breathlessness. Higher scores indicate worse outcomes (i.e., more severe dyspnea). Measurements will be taken at baseline and after the 8-week intervention. The primary analysis will focus on the change in median score from pre- to post-intervention within and between groups.; MaximumHigher scores indicate worse dyspnea (more severe breathlessness) score: 10

Secondary Outcome Measures

Name	Time	Method
Change in Distance Walked during 6-Minute Walk Test (6MWT)	4 weeks	Total distance walked (in meters) during the 6MWT will be recorded. Higher distance reflects improved functional capacity.

Trial Locations

Locations (1)

Arjumand; 🇵🇰 Lahore, Punjab, Pakistan