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NCT Number: NCT07079527

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Microcephaly, Primary Autosomal Recessive, 6 Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arjumand

Lahore, Punjab Province, 40100, Pakistan

Location contact

Arjumand Bano, MS-CPPT

CONTACT

[email protected]

03059551883

Naima Aqeel, MS-CPPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Positive End Expiratory Pressure (PEEP) Therapy

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

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.

Primary outcomes

  1. Change in SpO₂ (Oxygen Saturation) from Baseline to Post-Intervention

    Time frame: 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.

  2. Change in Respiratory Rate (RR) from Baseline to Post-Intervention

    Time frame: 4 weeks

    Respiratory rate (breaths per minute) will be recorded at baseline and after 4 weeks. Lower respiratory rate post-intervention reflects clinical improvement.

  3. Borg Dyspnea Scale Score from Baseline to Post-Intervention at 4 weeks

    Time frame: 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 outcomes

  1. Change in Distance Walked during 6-Minute Walk Test (6MWT)

    Time frame: 4 weeks

    Total distance walked (in meters) during the 6MWT will be recorded. Higher distance reflects improved functional capacity.

Study contacts

Contact information is provided by the study sponsor or research team.

Arjumand Bano, Ms CPPT

CONTACT

[email protected]

03059551883

imran amjad, phd

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Manual Positive End Expiratory Pressure and Non Invasive Continuous Air Pressure in COPD Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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