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

2026年7月27日 更新者：Riphah International University

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

28

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 巴基斯坦
    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦、55000
        • 招聘中
        • Riphah International University
        • 接触：
        • 首席研究员：
          • Humera Ayub, MSCPPT
        • 首席研究员：
          • Tanzeela Nazir, MSCPPT

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Acapella Device Group
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.
设备：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.
有源比较器：Flutter Device Group
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.
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Dyspnea Score
大体时间：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).
Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Forced Expiratory Volume in One Second (FEV₁)
大体时间：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).
Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Forced Vital Capacity (FVC)
大体时间：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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
大体时间：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 (%).
Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

次要结果测量

结果测量
措施说明
大体时间
Sputum Volume
大体时间：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.
Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Partial Pressure of Oxygen (PaO₂)
大体时间：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).
Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Partial Pressure of Carbon Dioxide (PaCO₂)
大体时间：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).
Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Arterial Blood pH
大体时间：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Arterial blood pH measured using arterial blood gas analysis.
Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
Bicarbonate Concentration (HCO₃-)
大体时间：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).
Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5

其他结果措施

结果测量
措施说明
大体时间
Presence of Postoperative Atelectasis on Chest X-ray
大体时间：Postoperative Day 1 and Postoperative Day 5
Number of participants with radiographic evidence of postoperative atelectasis as assessed by standard chest radiography.
Postoperative Day 1 and Postoperative Day 5
Presence of Pleural Effusion on Chest X-ray
大体时间：Postoperative Day 1 and Postoperative Day 5
Number of participants with radiographic evidence of pleural effusion as assessed by standard chest radiography.
Postoperative Day 1 and Postoperative Day 5

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Riphah International University

调查人员

  • 首席研究员：Tanzeela Nazir, MSCPPT、Riphah International University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月20日

初级完成 (估计的)

2026年11月15日

研究完成 (估计的)

2026年12月15日

研究注册日期

首次提交

2026年7月21日

首先提交符合 QC 标准的

2026年7月27日

首次发布 (实际的)

2026年7月30日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • REC/RCR & AHS/25/0316

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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