Pleural EffusionNCT07248774
Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry in Pleural Effusion
A study testing Bubble PEP and Incentive Spirometery in people with Pleural Effusion, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Bubble PEP and Incentive Spirometery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
The Children Hospital and University of Child Health Sciences
Lahore, Punjab Province, 54000
IMRAN AMJAD, PhD, 9233224390125, imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS-PT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry on Lung Expansion and Dyspnea in Children With 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.
Read the 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
- Being tested
- Bubble PEP, Incentive Spirometery
- Keywords
- Pleural effusion, PEP, Segmental Breathing, Dyspnea
- Medical subject headings
- Pleural Effusion, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble PEPOther
Also called Segmental Breathing
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 SpirometeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Incentive Spirometery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 2 weeks
Secondary outcomes (3)
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.
Measured: Baseline, 2 weeks
Oxygen Saturation
Oxygen saturation (SpO2) will be measured using a pulse oximeter to evaluate improvements in oxygenation resulting from enhanced lung function.
Measured: Baseline, 2 weeks
Respiratory Rate
The respiratory rate can be manually counted or evaluated using respiratory monitoring equipment, offering an objective measure of respiratory efficiency.
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start28 Oct 2025
- Primary completion5 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tayyba Bari, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248774
- Sponsor's protocol ID
- REC/RCR&AHS/TAYYBABARI
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31843426
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry on Lung Expansion and Dyspnea in Children With Pleural Effusion
- ClinicalTrials.gov ID
- NCT07248774
- Acronym / sponsor ID
- REC/RCR&AHS/TAYYBABARI
- Conditions
- Pleural Effusion
- Keywords
- Pleural effusion, PEP, Segmental Breathing, Dyspnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 5 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: Intervention Group (Bubble PEP + Segmental Breathing) | Active comparator | Other: Bubble PEPThe 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 B: Control Group (Incentive Spirometry) | Active comparator | Other: Incentive SpirometeryParticipants 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bubble PEPAlso: Segmental BreathingBubble 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 | Group A: Intervention Group (Bubble PEP + Segmental Breathing) |
| Incentive SpirometeryIncentive 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. | Other | Group B: Control Group (Incentive Spirometry) |
Primary outcome
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.
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.
3 secondary outcomes
Chest Expansion
Time frame: Baseline, 2 weeks
Oxygen Saturation
Time frame: Baseline, 2 weeks
Respiratory Rate
Time frame: Baseline, 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 31843426Dos 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.
- Individual participant dataSharing planned: No
Related trials for Pleural Effusion
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tayyba Bari, MS-PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bubble PEP and Incentive Spirometery in people with Pleural Effusion, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Expansion (time frame: Baseline, 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07248774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.