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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Humera Ayub, MSCPPT
- Telefonní číslo: +923045938096
- E-mail: humera.ayub@riphah.edu.pk
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 55000
- Nábor
- Riphah International University
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Kontakt:
- Tanzeela Nazir, MSCPPT
- Telefonní číslo: +92-300-0334782
- E-mail: tanzeela.nazir@riphah.edu
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Vrchní vyšetřovatel:
- Humera Ayub, MSCPPT
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Vrchní vyšetřovatel:
- Tanzeela Nazir, MSCPPT
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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Aktivní komparátor: 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.
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Dyspnea Score
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Sputum Volume
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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-)
Časové okno: 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
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Presence of Postoperative Atelectasis on Chest X-ray
Časové okno: 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
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Presence of Pleural Effusion on Chest X-ray
Časové okno: 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.
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Postoperative Day 1 and Postoperative Day 5
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Tanzeela Nazir, MSCPPT, Riphah International University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- REC/RCR & AHS/25/0316
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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