Acapella vs Flutter Devices for Improving Breathing and Lung Function After Lobectomy
Comparative Effects of Acapella and Flutter Devices on Secretion Clearance, Dyspnea, Arterial Blood Gases, and Lung Function Test in Post-Lobectomy Patients
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Humera Ayub, MSCPPT
- 電話番号：+923045938096
- メール：humera.ayub@riphah.edu.pk
研究場所
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Punjab Province
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Lahore、Punjab Province、パキスタン、55000
- 募集
- Riphah International University
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コンタクト：
- Tanzeela Nazir, MSCPPT
- 電話番号：+92-300-0334782
- メール：tanzeela.nazir@riphah.edu
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主任研究者：
- Humera Ayub, MSCPPT
-
主任研究者：
- Tanzeela Nazir, MSCPPT
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
|
|
アクティブコンパレータ：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.
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Dyspnea Score
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Change in perceived breathlessness measured using the Modified Borg Dyspnea Scale (0-10, higher scores indicate greater dyspnea).
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Forced Expiratory Volume in One Second (FEV₁)
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Forced Expiratory Volume in one second (FEV₁) measured using spirometry and reported in liters (L).
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Forced Vital Capacity (FVC)
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Forced Vital Capacity (FVC) measured using spirometry and reported in liters (L).
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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FEV₁/FVC Ratio
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Ratio of Forced Expiratory Volume in one second to Forced Vital Capacity (FEV₁/FVC) measured using spirometry and reported as a percentage (%).
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sputum Volume
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Volume of sputum expectorated over a 24-hour period, reported in milliliters (mL), to assess airway secretion clearance.
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
|
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Partial Pressure of Oxygen (PaO₂)
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Arterial partial pressure of oxygen (PaO₂) measured using arterial blood gas analysis and reported in millimeters of mercury (mmHg).
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
|
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Partial Pressure of Carbon Dioxide (PaCO₂)
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Arterial partial pressure of carbon dioxide (PaCO₂) measured using arterial blood gas analysis and reported in millimeters of mercury (mmHg).
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Arterial Blood pH
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Arterial blood pH measured using arterial blood gas analysis.
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
|
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Bicarbonate Concentration (HCO₃-)
時間枠：Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
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Arterial bicarbonate (HCO₃-) concentration measured using arterial blood gas analysis and reported in millimoles per liter (mmol/L).
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Postoperative Day 1, Postoperative Day 3, and Postoperative Day 5
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Presence of Postoperative Atelectasis on Chest X-ray
時間枠：Postoperative Day 1 and Postoperative Day 5
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Number of participants with radiographic evidence of postoperative atelectasis as assessed by standard chest radiography.
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Postoperative Day 1 and Postoperative Day 5
|
|
Presence of Pleural Effusion on Chest X-ray
時間枠：Postoperative Day 1 and Postoperative Day 5
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Number of participants with radiographic evidence of pleural effusion as assessed by standard chest radiography.
|
Postoperative Day 1 and Postoperative Day 5
|
協力者と研究者
捜査官
- 主任研究者：Tanzeela Nazir, MSCPPT、Riphah International University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- REC/RCR & AHS/25/0316
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
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