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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

• Sputum Volume [Срок оценки: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]
• Partial Pressure of Oxygen (PaO₂) [Срок оценки: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]
• Partial Pressure of Carbon Dioxide (PaCO₂) [Срок оценки: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]
• Arterial Blood pH [Срок оценки: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]
• Bicarbonate Concentration (HCO₃-) [Срок оценки: Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Riphah International University — Lahore

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗