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NCT Number: NCT07737093

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

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.

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Key information

Conditions

Age range

35 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 55000, Pakistan

Location status: Recruiting

Location contact

Humera Ayub, MSCPPT

PRINCIPAL_INVESTIGATOR

Tanzeela Nazir, MSCPPT

CONTACT

[email protected]

+92-300-0334782

Tanzeela Nazir, MSCPPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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 (%).

Secondary outcomes

  1. Sputum Volume

    Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

    Volume of sputum expectorated over a 24-hour period, reported in milliliters (mL), to assess airway secretion clearance.

  2. Partial Pressure of Oxygen (PaO₂)

    Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

    Arterial partial pressure of oxygen (PaO₂) measured using arterial blood gas analysis and reported in millimeters of mercury (mmHg).

  3. Partial Pressure of Carbon Dioxide (PaCO₂)

    Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

    Arterial partial pressure of carbon dioxide (PaCO₂) measured using arterial blood gas analysis and reported in millimeters of mercury (mmHg).

  4. Arterial Blood pH

    Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

    Arterial blood pH measured using arterial blood gas analysis.

  5. Bicarbonate Concentration (HCO₃-)

    Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

    Arterial bicarbonate (HCO₃-) concentration measured using arterial blood gas analysis and reported in millimoles per liter (mmol/L).

Other outcomes

  1. Presence of Postoperative Atelectasis on Chest X-ray

    Time frame: Postoperative Day 1 and Postoperative Day 5

    Number of participants with radiographic evidence of postoperative atelectasis as assessed by standard chest radiography.

  2. Presence of Pleural Effusion on Chest X-ray

    Time frame: Postoperative Day 1 and Postoperative Day 5

    Number of participants with radiographic evidence of pleural effusion as assessed by standard chest radiography.

Study contacts

Contact information is provided by the study sponsor or research team.

Humera Ayub, MSCPPT

CONTACT

[email protected]

+923045938096

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Acapella and Flutter Devices on Secretion Clearance, Dyspnea, Arterial Blood Gases, and Lung Function Test in Post-Lobectomy Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.