Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry in Pleural Effusion

NCT07248774 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/TAYYBABARI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Conducted as a randomized clinical trial, this study will include 40 pediatric participants aged 5-16, recruited from Gulab Devi Chest Hospital and Children's Hospital, Lahore. Participants will be randomly divided into two groups: one receiving Bubble PEP with Segmental Breathing and the other using Incentive Spirometry, both combined with conventional chest physiotherapy and mobility. Outcome measures, including lung expansion (via X-ray), dyspnea (assessed using the Pediatric Dyspnea Scale), chest expansion (measured with a measuring tape), oxygen saturation (SpO₂), and respiratory rate, will be recorded pre- and post-intervention. The study hypothesises that the Bubble PEP and Segmental Breathing approach may offer a cost-effective and efficient alternative to Incentive Spirometry, particularly for patients who cannot afford mechanical devices. Statistical analysis will be performed using SPSS version 2023 to determine the intervention's effects.

Conditions

Pleural Effusion

Keywords

Pleural effusion, PEP, Segmental Breathing, Dyspnea

Outcome Measures

Primary Outcomes (2)

• Lung Expansion

  To assess lung expansion before and after the intervention, anteroposterior chest X-rays will be used to evaluate improvements in lung volume and potential reductions in pleural effusion. This method allows for the measurement of lung field dimensions, changes in the opacity of lung areas affected by pleural effusion, and overall changes in thoracic structure that might indicate therapeutic effectiveness.

  Baseline, 2 weeks

• Pediatric Dyspnea Scale

  The Pediatric Dyspnea Scale (PDS) assesses subjective dyspnea in pediatric patients by using a visual and numerical scale, where patients indicate their perception of breathlessness. The PDS is scored from 1 through 7 where 1 indicates "No trouble at all" breathing and 7 indicates "Very much trouble" and a score of 1 through 7 was assigned accordingly.

  Baseline, 2 weeks

Secondary Outcomes (3)

• Chest Expansion

  Baseline, 2 weeks

• Oxygen Saturation

  Baseline, 2 weeks

• Respiratory Rate

  Baseline, 2 weeks

Study Arms (2)

Group A: Intervention Group (Bubble PEP + Segmental Breathing)

ACTIVE COMPARATOR

The experimental group will receive Bubble PEP therapy and Segmental Breathing along with conventional chest physiotherapy and mobility training. Bubble PEP will be performed using a bottle device where children exhale through a water-submerged tube, creating resistance to improve lung expansion and secretion clearance (10 repetitions, progressing from 1 to 3 sets over 14 days). Segmental Breathing will focus on localized lung expansion with therapist-guided tactile feedback, performed at six breaths per minute, progressing from 1 to 3 sets. Chest percussion will be applied for 2-5 minutes with rest intervals, and walking distance will increase from 1 to 5 meters. All sessions will be conducted once daily for two weeks.

Other: Bubble PEP

Group B: Control Group (Incentive Spirometry)

ACTIVE COMPARATOR

Participants in the control group will receive Incentive Spirometry along with conventional chest physiotherapy and mobility training. Incentive Spirometry will be used to encourage sustained maximal inspiration, thereby promoting lung expansion and improving ventilation. Each session will include three repetitions per side during Days 1-3, five repetitions per side during Days 4-7, and ten repetitions per side during Days 8-14, performed in one set per session. Chest percussion will be administered on the contralateral side to facilitate secretion mobilization, performed for two minutes on Days 1-3, three minutes on Days 4-7, and five minutes on Days 8-14, with 15 seconds of rest after each minute. Mobility training will include walking exercises, starting from one meter on Day 1, increasing to three meters by Day 3, and progressing to five meters from Day 4 onward, performed in two sets during Days 8-14. All sessions will be conducted once daily for two weeks.

Other: Incentive Spirometery

Interventions

Bubble PEP OTHER

Bubble PEP will be performed using a bottle device with 10 repetitions, progressing from one to three sets over 14 days. Segmental Breathing will target localized lung expansion with six breaths per minute, progressing similarly. Chest percussion will be applied on the contralateral side for 2-5 minutes with rest intervals, and walking distance will increase from 1 to 5 meters across the intervention period. All sessions will be conducted once daily for two weeks, with pre- and post-intervention assessments of lung expansion and dyspnea.

Also known as: Segmental Breathing

Group A: Intervention Group (Bubble PEP + Segmental Breathing)

Incentive Spirometery OTHER

Incentive Spirometry will be used to encourage sustained maximal inspiration, thereby promoting lung expansion and improving ventilation. Each session will include three repetitions per side during Days 1-3, five repetitions per side during Days 4-7, and ten repetitions per side during Days 8-14, performed in one set per session.

Group B: Control Group (Incentive Spirometry)

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

The Children Hospital and University of Child Health Sciences

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• Dos Santos EDC, da Silva JS, de Assis Filho MTT, Vidal MB, Monte MC, Lunardi AC. Adding positive airway pressure to mobilisation and respiratory techniques hastens pleural drainage: a randomised trial. J Physiother. 2020 Jan;66(1):19-26. doi: 10.1016/j.jphys.2019.11.006. Epub 2019 Dec 13.

  PMID: 31843426 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion; Dyspnea

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tayyba Bari, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols, and possible efforts will be put to mask both groups about the treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Conducted as a randomized clinical trial, this study will include 40 pediatric participants aged 5-16, recruited from Gulab Devi Chest Hospital and Children's Hospital, Lahore. Participants will be randomly divided into two groups: one receiving Bubble PEP with Segmental Breathing and the other using Incentive Spirometry, both combined with conventional chest physiotherapy and mobility. Outcome measures, including lung expansion (via X-ray), dyspnea (assessed using the Pediatric Dyspnea Scale), chest expansion (measured with a measuring tape), oxygen saturation (SpO₂), and respiratory rate, will be recorded pre- and post-intervention. The study hypothesises that the Bubble PEP and Segmental Breathing approach may offer a cost-effective and efficient alternative to Incentive Spirometry, particularly for patients who cannot afford mechanical devices. Statistical analysis will be performed using SPSS version 2023 to determine the intervention's effects.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 28, 2025
• Primary Completion: January 5, 2026
• Study Completion: January 15, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)