COPD
Conditions
Keywords
COPD, Posotive end expiratory pressure, CPAP
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.
Interventions
DEVICEManual 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.
DEVICENon-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.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Contacts
Primary Contactimran amjad, phd
Backup ContactArjumand Bano, Ms CPPT
Outcome results
None listed