Acapella vs Flutter Devices for Improving Breathing and Lung Function After Lobectomy

NCT07737093 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0316
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lobotomy Syndrome

Keywords

Acapella device Flutter device Post-lobectomy patients Secretion clearance Dyspnea Arterial blood gases Lung function Chest physiotherapy

Outcome Measures

Primary Outcomes (4)

• Change in Dyspnea Score

  Change in perceived breathlessness measured using the Modified Borg Dyspnea Scale (0-10, higher scores indicate greater dyspnea).

  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).

  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).

  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 (%).

  Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

Secondary Outcomes (5)

• Sputum Volume

  Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

• Partial Pressure of Oxygen (PaO₂)

  Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

• Partial Pressure of Carbon Dioxide (PaCO₂)

  Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

• Arterial Blood pH

  Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

• Bicarbonate Concentration (HCO₃-)

  Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

Other Outcomes (2)

• Presence of Postoperative Atelectasis on Chest X-ray

  Postoperative Day 1 and Postoperative Day 5

• Presence of Pleural Effusion on Chest X-ray

  Postoperative Day 1 and Postoperative Day 5

Study Arms (2)

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.

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.

Device: Flutter Device Therapy (Experimental Arm 2):

Interventions

Acapella Device Therapy (Experimental Arm 1): DEVICE

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.

Acapella Device Group

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.

Flutter Device Group

Eligibility Criteria

• Age: 35 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 55000, Pakistan

RECRUITING

Study Officials

• Tanzeela Nazir, MSCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Humera Ayub, MSCPPT

CONTACT

+923045938096; humera.ayub@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 30, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)