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

Official title

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

Overview

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.

Interventions

• Other 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
• 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.

Primary outcome measures

• Lung Expansion [Time frame: Baseline, 2 weeks]
• Pediatric Dyspnea Scale [Time frame: Baseline, 2 weeks]

Secondary outcome measures (3)

• Chest Expansion [Time frame: Baseline, 2 weeks]
• Oxygen Saturation [Time frame: Baseline, 2 weeks]
• Respiratory Rate [Time frame: Baseline, 2 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Pakistan · 1 center

• The Children Hospital and University of Child Health Sciences — Lahore

Publications

• 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

Identifiers

NCT: NCT07248774 · REC/RCR&AHS/TAYYBABARI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗