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

NCT ID: NCT07248774

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-28
• Study Completion Date: 2026-01-15

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.

Detailed Description

Pleural effusion is the pathological accumulation of excess fluid in the pleural cavity, compromising lung function by limiting expansion and reducing compliance. This condition leads to symptoms such as dyspnea and impaired gas exchange, which can significantly affect pediatric patients. Treatment often includes physical therapy techniques to facilitate lung expansion and improve respiratory function. The present study comprises Bubble Positive Expiratory Pressure, which involves exhalation through water to create resistance and improve expiratory volume, and Segmental Breathing, which enhances inspiratory volume for lung expansion. In contrast, Incentive Spirometry provides visual feedback to guide deep inhalation; it includes both upside and upside-down usage of the spirometer for the maintenance of pulmonary function and preventing alveolar collapse.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

Bubble PEP

Intervention Type: 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.

Group B: Control Group (Incentive Spirometry)

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.

Group Type: ACTIVE_COMPARATOR

Incentive Spirometery

Intervention Type: 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.

Interventions

Bubble PEP

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.

Intervention Type: OTHER

Incentive Spirometery

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.

Intervention Type: OTHER

Other Intervention Names

Segmental Breathing

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tayyba Bari, MS-PT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

The Children Hospital and University of Child Health Sciences

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

IMRAN AMJAD, PhD

Role: CONTACT

imran.amjad@riphah.edu.pk

9233224390125

Muhammad Asif Javed, MS-PT

Role: CONTACT

a.javed@riphah.edu.pk

923224209422

Facility Contacts

IMRAN AMJAD, PhD

Role: primary

imran.amjad@riphah.edu.pk

9233224390125

Muhammad Asif Javed, MS-PT

Role: backup

a.javed@riphah.edu.pk

923224209422

References

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.

Reference Type: BACKGROUND

PMID: 31843426 (View on PubMed)

Other Identifiers

REC/RCR&AHS/TAYYBABARI

Identifier Type: -

Identifier Source: org_study_id