- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07619716
ACBT With Incentive Spirometry Versus High-Frequency Chest Wall Oscillation After Thoracic Surgery
Effects of Active Cycle of Breathing Techniques With Incentive Spirometry Versus High-Frequency Chest Wall Oscillation on Cough, Sputum, Pulmonary Function Test and Patient Satisfaction After Thoracic Surgery
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Postoperative pulmonary complications are common after thoracic surgery due to reduced lung function and impaired secretion clearance. Effective respiratory physiotherapy is essential to improve recovery and prevent complications such as atelectasis and pneumonia.
This randomized clinical trial aims to compare the effectiveness of Active Cycle of Breathing Techniques combined with Incentive Spirometry (ACBT + IS) and High-Frequency Chest Wall Oscillation (HFCWO) in improving respiratory outcomes. A total of 42 patients undergoing elective thoracic surgery will be randomly assigned to either ACBT + IS or HFCWO, along with standard postoperative care.
Outcomes including cough effectiveness, sputum clearance, pulmonary function (FEV₁, FVC), and patient satisfaction will be assessed at baseline, postoperative day 3, and day 5. The study seeks to identify the more effective airway clearance technique to enhance recovery and reduce postoperative complications.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammad Iqbal Tariq, Phd*
- Número de teléfono: 03338236752
- Correo electrónico: iqbal.tariq@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 40100
- Gulab Devi Hospital or General Hospital Lahore.
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Contacto:
- Arjumand Bano, MS-CPPT
- Número de teléfono: 03059551883
- Correo electrónico: arjumand.bano@riphah.edu.pk
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Investigador principal:
- Sarah Nasir, MS-CPPT
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18-40 years
- Patients scheduled for elective thoracic surgery (e.g., lobectomy, pneumonectomy, thoracotomy, or VATS)
- Hemodynamically stable in the postoperative period
- Cognitively and physically able to perform breathing exercises and use devices (incentive spirometer/HFCWO vest)
- Willing to participate and provide informed consent
Exclusion Criteria:
- Pre-existing severe pulmonary diseases (e.g., COPD, cystic fibrosis, bronchiectasis)
- Contraindications to HFCWO (e.g., recent rib fractures, chest wall trauma, unstable cardiovascular status)
- Cognitive, neuromuscular, or musculoskeletal impairments limiting participation in interventions
- Prolonged mechanical ventilation (>24 hours postoperatively)
- Active pulmonary infection or hemoptysis within one week after surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: ACBT with Incentive Spirometry
Participants in this group will receive Active Cycle of Breathing Techniques (ACBT) combined with Incentive Spirometry along with standard postoperative care.
The ACBT protocol will include breathing control, thoracic expansion exercises, and forced expiratory techniques (huffing), performed multiple times daily.
Incentive spirometry will be used to promote deep breathing and lung expansion.
The intervention will begin in the early postoperative period and continue for 5 days.
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A structured breathing intervention combining Active Cycle of Breathing Techniques (breathing control, thoracic expansion exercises, and forced expiratory technique) with incentive spirometry to promote lung expansion and secretion clearance.
Performed multiple times daily during the early postoperative period.
Otros nombres:
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Experimental: High-Frequency Chest Wall Oscillation (HFCWO)
Participants in this group will receive High-Frequency Chest Wall Oscillation therapy using an oscillatory vest device along with standard postoperative care.
The device delivers external chest wall oscillations to mobilize pulmonary secretions.
The intervention will start on postoperative day 3 and will be administered twice daily for 5 days.
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A mechanical airway clearance technique delivered using an oscillatory vest that produces high-frequency chest wall vibrations to help mobilize and remove pulmonary secretions.
The intervention is administered twice daily beginning on postoperative day 3.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Forced Expiratory Volume in 1 second (FEV₁)
Periodo de tiempo: Baseline (preoperative), Postoperative Day 3, and Day 5
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Assessment of pulmonary function using spirometry parameters including Forced Expiratory Volume in 1 second (FEV₁) to evaluate respiratory recovery after thoracic surgery.
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Baseline (preoperative), Postoperative Day 3, and Day 5
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Forced Vital Capacity (FVC)
Periodo de tiempo: Baseline (preoperative), Postoperative Day 3, and Day 5
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Assessment of pulmonary function using spirometry parameters including Forced Vital Capacity (FVC) to evaluate respiratory recovery after thoracic surgery.
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Baseline (preoperative), Postoperative Day 3, and Day 5
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Cough Effectiveness
Periodo de tiempo: Baseline, Postoperative Day 3, and Day 5
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Evaluation of cough effectiveness using the Leicester Cough Questionnaire (LCQ), measuring physical, psychological, and social impact of cough.
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Baseline, Postoperative Day 3, and Day 5
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sputum Clearance
Periodo de tiempo: Postoperative Day 3 and Day 5
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Measurement of sputum volume to assess effectiveness of airway clearance techniques.
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Postoperative Day 3 and Day 5
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arjumand Bano, MSPT, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC/RCR & AHS/25/0323
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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