- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Muhammad Iqbal Tariq, Phd*
- Telefonnummer: 03338236752
- E-post: iqbal.tariq@riphah.edu.pk
Studieorter
-
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Punjab Province
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Lahore, Punjab Province, Pakistan, 40100
- Gulab Devi Hospital or General Hospital Lahore.
-
Kontakt:
- Arjumand Bano, MS-CPPT
- Telefonnummer: 03059551883
- E-post: arjumand.bano@riphah.edu.pk
-
Huvudutredare:
- Sarah Nasir, MS-CPPT
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
Andra namn:
|
|
Experimentell: 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.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Forced Expiratory Volume in 1 second (FEV₁)
Tidsram: Baseline (preoperative), Postoperative Day 3, and Day 5
|
Assessment of pulmonary function using spirometry parameters including Forced Expiratory Volume in 1 second (FEV₁) to evaluate respiratory recovery after thoracic surgery.
|
Baseline (preoperative), Postoperative Day 3, and Day 5
|
|
Forced Vital Capacity (FVC)
Tidsram: Baseline (preoperative), Postoperative Day 3, and Day 5
|
Assessment of pulmonary function using spirometry parameters including Forced Vital Capacity (FVC) to evaluate respiratory recovery after thoracic surgery.
|
Baseline (preoperative), Postoperative Day 3, and Day 5
|
|
Cough Effectiveness
Tidsram: Baseline, Postoperative Day 3, and Day 5
|
Evaluation of cough effectiveness using the Leicester Cough Questionnaire (LCQ), measuring physical, psychological, and social impact of cough.
|
Baseline, Postoperative Day 3, and Day 5
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sputum Clearance
Tidsram: Postoperative Day 3 and Day 5
|
Measurement of sputum volume to assess effectiveness of airway clearance techniques.
|
Postoperative Day 3 and Day 5
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Arjumand Bano, MSPT, Riphah International University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REC/RCR & AHS/25/0323
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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