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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-16
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 5 to 16.

Suffering from Pleural effusion or hydrothorax.

Thoracic drainage system in situ for 24 hours.

Either gender will be included.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bubble PEP

    Other intervention

    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.

  • Incentive Spirometery

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group A: Intervention Group (Bubble PEP + Segmental Breathing)Active comparator 1 intervention
Group B: Group B: Control Group (Incentive Spirometry)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 2 weeks
2

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.

Time frame
Baseline, 2 weeks

Secondary outcomes

1

Chest Expansion

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.

Time frame
Baseline, 2 weeks
2

Oxygen Saturation

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

Time frame
Baseline, 2 weeks
3

Respiratory Rate

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

Time frame
Baseline, 2 weeks

Other outcomes

Sponsors and contacts

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