- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Iqbal Tariq, Phd*
- Phone Number: 03338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 40100
- Gulab Devi Hospital or General Hospital Lahore.
-
Contact:
- Arjumand Bano, MS-CPPT
- Phone Number: 03059551883
- Email: arjumand.bano@riphah.edu.pk
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Principal Investigator:
- Sarah Nasir, MS-CPPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
Other Names:
|
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Expiratory Volume in 1 second (FEV₁)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sputum Clearance
Time Frame: Postoperative Day 3 and Day 5
|
Measurement of sputum volume to assess effectiveness of airway clearance techniques.
|
Postoperative Day 3 and Day 5
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arjumand Bano, MSPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/25/0323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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