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

Official title

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

Overview

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.

Interventions

• Device 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 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.

Primary outcome measures

• Change in Dyspnea Score [Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]
• Forced Expiratory Volume in One Second (FEV₁) [Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]
• Forced Vital Capacity (FVC) [Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]
• FEV₁/FVC Ratio [Time frame: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Riphah International University — Lahore

Identifiers

NCT: NCT07737093 · REC/RCR & AHS/25/0316

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗