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

NCT ID: NCT07079527

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-28
• Study Completion Date: 2025-12-10

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual PEEP Therapy

Participants in this group receive Manual Positive End Expiratory Pressure (PEEP) therapy. The therapy is administered using a tight-fitting mask that applies positive pressure at the end of expiration to keep alveoli open, enhance oxygenation, reduce airway collapse, and improve breathing efficiency. Sessions follow a standardized protocol over a 4-week period. All participants also receive Active Cycle of Breathing Techniques (ACBTs) as baseline therapy.

Group Type: EXPERIMENTAL

Manual Positive End Expiratory Pressure (PEEP) Therapy

Intervention Type: DEVICE

Participants in this group receive Manual Positive End Expiratory Pressure (PEEP) therapy. The intervention is delivered using a tight-fitting mask that applies positive pressure at the end of expiration, helping to keep the alveoli open, enhance oxygenation, and prevent airway collapse. The therapy is administered according to a structured protocol over a 4-week period, aiming to reduce breathlessness, improve lung function, and support ventilation. Along with PEEP, participants also receive baseline Active Cycle of Breathing Techniques (ACBTs) for airway clearance and breathing control.

Non-Invasive CPAP Therapy

Participants in this group receive Non-Invasive Continuous Positive Airway Pressure (CPAP) therapy. CPAP delivers a constant level of positive pressure throughout the respiratory cycle using a non-invasive ventilator. This helps reduce the work of breathing, improve gas exchange, and relieve symptoms of dyspnea. The intervention is delivered according to a standardized protocol for 4 weeks, along with baseline ACBTs.

Group Type: EXPERIMENTAL

Non-Invasive CPAP Therapy

Intervention Type: DEVICE

Participants in this group receive Non-Invasive Continuous Positive Airway Pressure (CPAP) therapy. CPAP provides a constant level of positive pressure throughout the entire breathing cycle using a non-invasive ventilator and a full-face or nasal mask. This therapy improves gas exchange, reduces the work of breathing, and eases symptoms such as dyspnea. Like Group A, CPAP therapy is delivered following a standardized protocol for 4 weeks, and participants also perform baseline ACBTs to support respiratory function.

Interventions

Manual Positive End Expiratory Pressure (PEEP) Therapy

Participants in this group receive Manual Positive End Expiratory Pressure (PEEP) therapy. The intervention is delivered using a tight-fitting mask that applies positive pressure at the end of expiration, helping to keep the alveoli open, enhance oxygenation, and prevent airway collapse. The therapy is administered according to a structured protocol over a 4-week period, aiming to reduce breathlessness, improve lung function, and support ventilation. Along with PEEP, participants also receive baseline Active Cycle of Breathing Techniques (ACBTs) for airway clearance and breathing control.

Intervention Type: DEVICE

Non-Invasive CPAP Therapy

Participants in this group receive Non-Invasive Continuous Positive Airway Pressure (CPAP) therapy. CPAP provides a constant level of positive pressure throughout the entire breathing cycle using a non-invasive ventilator and a full-face or nasal mask. This therapy improves gas exchange, reduces the work of breathing, and eases symptoms such as dyspnea. Like Group A, CPAP therapy is delivered following a standardized protocol for 4 weeks, and participants also perform baseline ACBTs to support respiratory function.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arjumand Bano, Ms CPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Arjumand

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

imran amjad, phd

Role: CONTACT

imran.amjad@riphah.edu.pk

03324390125

Arjumand Bano, Ms CPPT

Role: CONTACT

arjumand.bano@riphah.edu.pk

03059551883

Facility Contacts

Arjumand Bano, MS-CPPT

Role: primary

arjumand.bano@riphah.edu.pk

03059551883

Other Identifiers

REC/RCR&AHS/24/0357

Identifier Type: -

Identifier Source: org_study_id