Lobotomy SyndromeNCT07737093
Acapella vs Flutter Devices for Improving Breathing and Lung Function After Lobectomy
A study testing Acapella Device Therapy (Experimental Arm 1): and Flutter Device Therapy (Experimental Arm 2): in people with Lobotomy Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Lobectomy patients frequently experience postoperative respiratory complications such as secretion retention, dyspnea, impaired gas exchange, and reduced lung function, which can delay recovery. Read more about this study
- Who is it for?
- Ages 35 to 54 years
- Conditions the study is for
- Lobotomy Syndrome
- What is being tested?
- Acapella Device Therapy (Experimental Arm 1): and Flutter Device Therapy (Experimental Arm 2):
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2026to 15 Dec 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 35 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 35 to 54 years
- Both male and female patients
- Patients who have undergone lobectomy surgery
- Hemodynamically stable patients
- Patients with adequate respiratory function (able to maintain oxygenation)
- Patients 48 hours post-surgery
- Patients who provide written informed consent to participate in the study
Who cannot join
- Hemodynamically unstable patients
- Patients within less than 48 hours post-surgery
- Presence of pneumothorax or air leak complications
- Patients with recent major trauma or additional surgery
- Patients with unstable cardiac conditions
- Patients with massive hemoptysis
- Patients unable to cooperate or perform breathing exercises with devices
- Any contraindication to airway clearance techniques as judged by the clinician
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
Riphah International University
Lahore, Punjab Province, 55000
Tanzeela Nazir, MSCPPT, +92-300-0334782, tanzeela.nazir@riphah.edu
Humera Ayub, MSCPPT
About this study
Official title: Comparative Effects of Acapella and Flutter Devices on Secretion Clearance, Dyspnea, Arterial Blood Gases, and Lung Function Test in Post-Lobectomy Patients
Lobectomy patients frequently experience postoperative respiratory complications such as secretion retention, dyspnea, impaired gas exchange, and reduced lung function, which can delay recovery. Oscillatory Positive Expiratory Pressure (OPEP) devices such as Acapella and Flutter are commonly used to improve airway clearance and pulmonary function. This study aims to compare the effects of Acapella and Flutter devices on secretion clearance, dyspnea, arterial blood gases, and lung function in post-lobectomy patients.
Read the detailed description
Lobectomy is a common surgical procedure performed for the treatment of various pulmonary conditions, particularly lung cancer. Although effective, the procedure is often associated with postoperative respiratory complications including mucus retention, reduced lung volumes, impaired ventilation, and difficulty breathing. These complications can prolong hospital stay, increase the risk of infection, and negatively affect functional recovery.
Respiratory physiotherapy plays an important role in preventing and managing these complications. Oscillatory Positive Expiratory Pressure (OPEP) devices are widely used to facilitate airway clearance by generating positive expiratory pressure and oscillations during exhalation. These mechanisms help mobilize retained secretions, improve ventilation, enhance lung expansion, and support overall pulmonary recovery.
Acapella and Flutter are two commonly used OPEP devices. Both have demonstrated beneficial effects on mucus clearance, pulmonary function, oxygenation, and symptom management in patients with respiratory disorders and postoperative conditions. Previous studies have reported improvements in respiratory parameters and functional outcomes following the use of these devices as part of pulmonary rehabilitation programs.
Despite the growing use of OPEP devices in clinical practice, evidence directly comparing Acapella and Flutter in patients recovering from lobectomy remains limited. Most available studies have focused on chronic respiratory diseases or evaluated these devices independently rather than comparing their effectiveness in a postoperative population. Furthermore, limited information is available regarding their relative effects on secretion clearance, dyspnea, arterial blood gases, and lung function after lobectomy. Therefore, this study is designed to address this gap and provide evidence regarding the comparative effectiveness of Acapella and Flutter devices in postoperative pulmonary rehabilitation.
- Conditions
- Lobotomy Syndrome
- Being tested
- Acapella Device Therapy (Experimental Arm 1):, Flutter Device Therapy (Experimental Arm 2):
- Keywords
- Acapella device Flutter device Post-lobectomy patients Secretion clearance Dyspnea Arterial blood gases Lung function Chest physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella Device Therapy (Experimental Arm 1):Device
- Acapella Device Therapy (Experimental Arm 1): Participants will use the Acapella device, which provides a combination of oscillating positive expiratory pressure (OPEP) and airway vibration to facilitate mucus clearance. Patients will be trained in proper technique and will perform the intervention twice daily for 7 days. Each session will follow a standardized protocol to ensure consistency in breathing pattern and device usage.
Flutter Device Therapy (Experimental Arm 2):Device
Flutter Device Therapy (Experimental Arm 2):
Participants will use the Flutter device, which generates oscillating positive expiratory pressure during exhalation to mobilize bronchial secretions. Patients will be instructed in correct positioning and breathing technique. The intervention will also be administered twice daily for 7 days using a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| Acapella Device Group | Experimental | Participants in this arm will receive airway clearance therapy using the Acapella device. The device combines both positive expiratory pressure (PEP) and airway vibration to enhance mobilization of bronchial secretions. Patients will be trained to perform standardized breathing techniques using the device. The intervention will be administered twice daily for 7 days, under supervision during hospital stay or as per protocol guidelines. Standard post-lobectomy care will be continued alongside the intervention. Receives: Device: Acapella Device Therapy (Experimental Arm 1): |
| Flutter Device Group | Active comparator | Participants in this arm will receive airway clearance therapy using the Flutter device, which generates oscillatory positive expiratory pressure to loosen and mobilize airway secretions. Patients will be instructed in proper usage technique to ensure effective airflow oscillation during exhalation. The intervention will be performed twice daily for 7 days, following a standardized protocol similar to the Acapella group. Routine post-operative care will be provided in addition to the intervention. Receives: Device: Flutter Device Therapy (Experimental Arm 2): |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dyspnea Score
Change in perceived breathlessness measured using the Modified Borg Dyspnea Scale (0-10, higher scores indicate greater dyspnea).
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Forced Expiratory Volume in One Second (FEV₁)
Forced Expiratory Volume in one second (FEV₁) measured using spirometry and reported in liters (L).
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) measured using spirometry and reported in liters (L).
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
FEV₁/FVC Ratio
Ratio of Forced Expiratory Volume in one second to Forced Vital Capacity (FEV₁/FVC) measured using spirometry and reported as a percentage (%).
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Secondary outcomes (5)
Sputum Volume
Volume of sputum expectorated over a 24-hour period, reported in milliliters (mL), to assess airway secretion clearance.
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Partial Pressure of Oxygen (PaO₂)
Arterial partial pressure of oxygen (PaO₂) measured using arterial blood gas analysis and reported in millimeters of mercury (mmHg).
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Partial Pressure of Carbon Dioxide (PaCO₂)
Arterial partial pressure of carbon dioxide (PaCO₂) measured using arterial blood gas analysis and reported in millimeters of mercury (mmHg).
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Arterial Blood pH
Arterial blood pH measured using arterial blood gas analysis.
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Bicarbonate Concentration (HCO₃-)
Arterial bicarbonate (HCO₃-) concentration measured using arterial blood gas analysis and reported in millimoles per liter (mmol/L).
Measured: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start20 Jun 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lobotomy SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will follow a parallel-group, randomized controlled trial design with two intervention arms. Eligible post-lobectomy patients will be randomly allocated into: Group A: Acapella device therapy Group B: Flutter device therapy Both groups will receive the assigned intervention using a standardized protocol (2 sessions per day for 7 days). The interventions will be delivered in a parallel manner, meaning each participant will remain in their originally assigned group throughout the study without crossover. Outcome measures, including dyspnea (Modified Borg Scale), lung function (spirometry), arterial blood gases, and secretion clearance, will be assessed at baseline, day 3, and day 5 to evaluate within-group changes over time and between-group differences in treatment effects. The study is single-blinded, where the outcome assessor will be blinded to group allocation to minimize assessment bias.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanzeela Nazir, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737093
- Sponsor's protocol ID
- REC/RCR & AHS/25/0316
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) from this study will not be shared publicly due to ethical and privacy considerations, including the risk of identifying post-lobectomy patients from a small sample size. Additionally, the data may contain sensitive clinical information such as arterial blood gas results and postoperative respiratory status, which require strict confidentiality. However, de-identified aggregate data may be available upon reasonable request from the corresponding investigator, subject to institutional approval and ethical committee permissions.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Acapella and Flutter Devices on Secretion Clearance, Dyspnea, Arterial Blood Gases, and Lung Function Test in Post-Lobectomy Patients
- ClinicalTrials.gov ID
- NCT07737093
- Acronym / sponsor ID
- REC/RCR & AHS/25/0316
- Conditions
- Lobotomy Syndrome
- Keywords
- Acapella device Flutter device Post-lobectomy patients Secretion clearance Dyspnea Arterial blood gases Lung function Chest physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 30 Jul 2026 (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.
Lobectomy patients frequently experience postoperative respiratory complications such as secretion retention, dyspnea, impaired gas exchange, and reduced lung function, which can delay recovery. Oscillatory Positive Expiratory Pressure (OPEP) devices such as Acapella and Flutter are commonly used to improve airway clearance and pulmonary function. This study aims to compare the effects of Acapella and Flutter devices on secretion clearance, dyspnea, arterial blood gases, and lung function in post-lobectomy patients.
Detailed description
Lobectomy is a common surgical procedure performed for the treatment of various pulmonary conditions, particularly lung cancer. Although effective, the procedure is often associated with postoperative respiratory complications including mucus retention, reduced lung volumes, impaired ventilation, and difficulty breathing. These complications can prolong hospital stay, increase the risk of infection, and negatively affect functional recovery.
Respiratory physiotherapy plays an important role in preventing and managing these complications. Oscillatory Positive Expiratory Pressure (OPEP) devices are widely used to facilitate airway clearance by generating positive expiratory pressure and oscillations during exhalation. These mechanisms help mobilize retained secretions, improve ventilation, enhance lung expansion, and support overall pulmonary recovery.
Acapella and Flutter are two commonly used OPEP devices. Both have demonstrated beneficial effects on mucus clearance, pulmonary function, oxygenation, and symptom management in patients with respiratory disorders and postoperative conditions. Previous studies have reported improvements in respiratory parameters and functional outcomes following the use of these devices as part of pulmonary rehabilitation programs.
Despite the growing use of OPEP devices in clinical practice, evidence directly comparing Acapella and Flutter in patients recovering from lobectomy remains limited. Most available studies have focused on chronic respiratory diseases or evaluated these devices independently rather than comparing their effectiveness in a postoperative population. Furthermore, limited information is available regarding their relative effects on secretion clearance, dyspnea, arterial blood gases, and lung function after lobectomy. Therefore, this study is designed to address this gap and provide evidence regarding the comparative effectiveness of Acapella and Flutter devices in postoperative pulmonary rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will follow a parallel-group, randomized controlled trial design with two intervention arms. Eligible post-lobectomy patients will be randomly allocated into: Group A: Acapella device therapy Group B: Flutter device therapy Both groups will receive the assigned intervention using a standardized protocol (2 sessions per day for 7 days). The interventions will be delivered in a parallel manner, meaning each participant will remain in their originally assigned group throughout the study without crossover. Outcome measures, including dyspnea (Modified Borg Scale), lung function (spirometry), arterial blood gases, and secretion clearance, will be assessed at baseline, day 3, and day 5 to evaluate within-group changes over time and between-group differences in treatment effects. The study is single-blinded, where the outcome assessor will be blinded to group allocation to minimize assessment bias.
| Arm | Type | Receives |
|---|---|---|
| Acapella Device Group | Experimental | Device: Acapella Device Therapy (Experimental Arm 1):Participants in this arm will receive airway clearance therapy using the Acapella device. The device combines both positive expiratory pressure (PEP) and airway vibration to enhance mobilization of bronchial secretions. Patients will be trained to perform standardized breathing techniques using the device. The intervention will be administered twice daily for 7 days, under supervision during hospital stay or as per protocol guidelines. Standard post-lobectomy care will be continued alongside the intervention. |
| Flutter Device Group | Active comparator | Device: Flutter Device Therapy (Experimental Arm 2):Participants in this arm will receive airway clearance therapy using the Flutter device, which generates oscillatory positive expiratory pressure to loosen and mobilize airway secretions. Patients will be instructed in proper usage technique to ensure effective airflow oscillation during exhalation. The intervention will be performed twice daily for 7 days, following a standardized protocol similar to the Acapella group. Routine post-operative care will be provided in addition to the intervention. |
Who may qualify
- Ages
- 35 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged 35 to 54 years
- Both male and female patients
- Patients who have undergone lobectomy surgery
- Hemodynamically stable patients
- Patients with adequate respiratory function (able to maintain oxygenation)
Key exclusion criteria (8 listed)
- Hemodynamically unstable patients
- Patients within less than 48 hours post-surgery
- Presence of pneumothorax or air leak complications
- Patients with recent major trauma or additional surgery
- Patients with unstable cardiac conditions
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 |
|---|---|---|
| Acapella Device Therapy (Experimental Arm 1):1. Acapella Device Therapy (Experimental Arm 1): Participants will use the Acapella device, which provides a combination of oscillating positive expiratory pressure (OPEP) and airway vibration to facilitate mucus clearance. Patients will be trained in proper technique and will perform the intervention twice daily for 7 days. Each session will follow a standardized protocol to ensure consistency in breathing pattern and device usage. | Device | Acapella Device Group |
| Flutter Device Therapy (Experimental Arm 2):Flutter Device Therapy (Experimental Arm 2): Participants will use the Flutter device, which generates oscillating positive expiratory pressure during exhalation to mobilize bronchial secretions. Patients will be instructed in correct positioning and breathing technique. The intervention will also be administered twice daily for 7 days using a standardized protocol. | Device | Flutter Device Group |
Primary outcome
Change in Dyspnea Score
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Change in perceived breathlessness measured using the Modified Borg Dyspnea Scale (0-10, higher scores indicate greater dyspnea).
Forced Expiratory Volume in One Second (FEV₁)
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Forced Expiratory Volume in one second (FEV₁) measured using spirometry and reported in liters (L).
Forced Vital Capacity (FVC)
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Forced Vital Capacity (FVC) measured using spirometry and reported in liters (L).
FEV₁/FVC Ratio
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Ratio of Forced Expiratory Volume in one second to Forced Vital Capacity (FEV₁/FVC) measured using spirometry and reported as a percentage (%).
5 secondary outcomes
Sputum Volume
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Partial Pressure of Oxygen (PaO₂)
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Partial Pressure of Carbon Dioxide (PaCO₂)
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Arterial Blood pH
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Bicarbonate Concentration (HCO₃-)
Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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 30 Jul 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) from this study will not be shared publicly due to ethical and privacy considerations, including the risk of identifying post-lobectomy patients from a small sample size. Additionally, the data may contain sensitive clinical information such as arterial blood gas results and postoperative respiratory status, which require strict confidentiality. However, de-identified aggregate data may be available upon reasonable request from the corresponding investigator, subject to institutional approval and ethical committee permissions.
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.
Tanzeela Nazir, MSCPPT 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 Acapella Device Therapy (Experimental Arm 1): and Flutter Device Therapy (Experimental Arm 2): in people with Lobotomy Syndrome, 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 7 inclusion and 8 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 30 Jul 2026. 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 Humera Ayub, MSCPPT (+923045938096, humera.ayub@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dyspnea Score (time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.