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NCT Number: NCT07248774

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

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.

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Key information

Conditions

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

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Primary outcomes

  1. Lung Expansion

    Time frame: Baseline, 2 weeks

    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.

  2. Pediatric Dyspnea Scale

    Time frame: Baseline, 2 weeks

    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.

Secondary outcomes

  1. Chest Expansion

    Time frame: Baseline, 2 weeks

    Chest expansion will be measured with the help of tape method at different stages of the chest which measures symmetry and extent of expansion. The levels of measurements are at sternal notch, at xiphoid process and at T8vertebral level.

  2. Oxygen Saturation

    Time frame: Baseline, 2 weeks

    Oxygen saturation (SpO2) will be measured using a pulse oximeter to evaluate improvements in oxygenation resulting from enhanced lung function.

  3. Respiratory Rate

    Time frame: Baseline, 2 weeks

    The respiratory rate can be manually counted or evaluated using respiratory monitoring equipment, offering an objective measure of respiratory efficiency.

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry on Lung Expansion and Dyspnea in Children With Pleural Effusion

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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