Comparative Effects of Manual Positive End Expiratory Pressure and Non Invasive Continuous Air Pressure in COPD Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change in SpO₂ (Oxygen Saturation) from Baseline to Post-Intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Manual Positive End Expiratory Pressure (PEEP) Therapy (Device)
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.
Intervention: Non-Invasive CPAP Therapy (Device)
Outcomes
Primary Outcomes
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.
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.
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
- Change in Distance Walked during 6-Minute Walk Test (6MWT)(4 weeks)