Bubble PEP plus Segmental Breathing versus Incentive Spirometry for children with pleural effusion
Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry on Lung Expansion and Dyspnea in Children With Pleural Effusion
This trial will test whether bubble positive expiratory pressure with segmental breathing helps children aged 5–16 with pleural effusion breathe better than incentive spirometry.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 5 Years to 16 Years |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07248774 on ClinicalTrials.gov |
What this trial studies
This is a randomized clinical trial enrolling 40 pediatric patients aged 5–16 at hospitals in Lahore who have pleural effusion. Participants are randomly assigned to receive either Bubble PEP with segmental breathing or incentive spirometry, with both groups also receiving conventional chest physiotherapy and mobility. Outcomes measured before and after the intervention include lung expansion on chest X-ray, dyspnea using the Pediatric Dyspnea Scale, chest expansion by tape measure, oxygen saturation (SpO₂), and respiratory rate. The study tests whether the low-cost Bubble PEP approach can be an effective alternative to mechanical incentive spirometers in this population.
Who should consider this trial
Good fit: Ideal candidates are children aged 5–16 with pleural effusion or hydrothorax who have had a thoracic drainage system in place for at least 24 hours and no other coexisting illnesses.
Not a fit: Patients with other pulmonary pathologies, chest trauma, pneumothorax, hemothorax, chylothorax, significant chest pain, musculoskeletal chest deformities, or comorbid causes of effusion are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could offer a low-cost, effective way to improve lung expansion and breathing in children with pleural effusion.
How similar studies have performed: PEP techniques and incentive spirometry have shown benefits for airway clearance and lung expansion in other populations, but direct comparisons in pediatric pleural effusion are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 5 to 16. * Suffering from Pleural effusion or hydrothorax. * Thoracic drainage system in situ for 24 hours. * Either gender will be included. * Patients without any other co-existing illness. Exclusion Criteria: * Any other pulmonary pathology that does not fit the diagnostic criteria of Pleural Effusion. * Participants with unbearable chest pain, chylothorax, hemothorax, pneumothorax, chest trauma or rib fracture. * Participants with other comorbidities leading to pleural effusion. * Patients who have chest musculoskeletal deformities.
Where this trial is running
Lahore, Punjab Province
- The Children Hospital and University of Child Health Sciences — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Tayyba Bari, MS-PT — Riphah International University
- Study coordinator: IMRAN AMJAD, PhD
- Email: imran.amjad@riphah.edu.pk
- Phone: 9233224390125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.