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
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Humera Ayub, MSCPPT
- Número de telefone: +923045938096
- E-mail: humera.ayub@riphah.edu.pk
Locais de estudo
-
-
Punjab Province
-
Lahore, Punjab Province, Paquistão, 55000
- Recrutamento
- Riphah International University
-
Contato:
- Tanzeela Nazir, MSCPPT
- Número de telefone: +92-300-0334782
- E-mail: tanzeela.nazir@riphah.edu
-
Investigador principal:
- Humera Ayub, MSCPPT
-
Investigador principal:
- Tanzeela Nazir, MSCPPT
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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.
|
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Dyspnea Score
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sputum Volume
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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-)
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Presence of Postoperative Atelectasis on Chest X-ray
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tanzeela Nazir, MSCPPT, Riphah International University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- REC/RCR & AHS/25/0316
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .