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

NCT07079527 | Not Yet Recruiting

• 1 other identifier: REC/RCR&AHS/24/0357
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD, Posotive end expiratory pressure, CPAP

Outcome Measures

Primary Outcomes (3)

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

  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.

  4 weeks

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

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

  4 weeks

• Borg Dyspnea Scale Score from Baseline to Post-Intervention at 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

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (2)

Manual PEEP Therapy

EXPERIMENTAL

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.

Device: Manual Positive End Expiratory Pressure (PEEP) Therapy

Non-Invasive CPAP Therapy

EXPERIMENTAL

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.

Device: Non-Invasive CPAP Therapy

Interventions

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.

Manual PEEP Therapy

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.

Non-Invasive CPAP Therapy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Arjumand

Lahore, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Microcephaly, Primary Autosomal Recessive, 6

Interventions

Positive-Pressure Respiration; Therapeutics

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Arjumand Bano, Ms CPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Arjumand Bano, Ms CPPT

CONTACT

03059551883; arjumand.bano@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: July 28, 2025
• Primary Completion: November 28, 2025
• Study Completion: December 10, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)