Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients

Not Applicable

Completed

• Conditions: CABG
• Interventions: Other: Base Line + Manual Chest Physiotherapy; Other: Base Line + ACEPELLA

• Registration Number: NCT06317363
• Lead Sponsor: Riphah International University

Brief Summary

Coronary artery bypass grafting (CABG) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. CABG is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. Chest physiotherapy is commonly use to prevent and treat these complications, but its effectiveness in post-operative CABG patients is not well established.

The purpose of this study is to evaluate the effects of Acapella device vs chest physiotherapy on pulmonary function, airway clearance and dyspnea in post-operative CABG patients. The group A will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella), while the group B will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute The primary outcome measures of the study will be pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC, and Modified Borg dyspnea scale . The secondary outcome measures will be the amount of sputum cleared. The study will be conducted over a period of 6 months after approval of synopsis.

The study will be conducted in a tertiary care hospital in Lahore, Pakistan. Patients who have undergone CABG surgery will be screen for eligibility and those who meet the inclusion criteria will be enroll in the study. Patients who have a history of chronic lung disease, smoking, intubated patient or other respiratory conditions will be exclude from the study

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-23
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-15
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-17
• Last Update Submitted: 2024-03-17
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• both gender
• Patients aged between 55-70 years
• Vitally Stable
• extubated post-CABG day 01 patients
• Patient undergone for the 1st time CABG

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Exclusion Criteria

• With a history of chronic obstructive pulmonary disease or asthma patient
• Intubated patient
• Surgical complication after CABG
• With a history of smoking
• Patients who have undergone thoracic surgery in the past
• Patients with a history of neuromuscular disorders
• Patients with a history of heart failure
• Vitally unstable or on ventilator post CABG patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group B (MANUAL CHEST PHYSIOTHERAPY)	Base Line + Manual Chest Physiotherapy	Group B (baseline + manual chest physiotherapy)
Experimental Group A (ACAPELLA)	Base Line + ACEPELLA	Group A (baseline treatment + acapella)

Primary Outcome Measures

Name	Time	Method
FEV1/FVC	1 week	digital spirometer device will be used to take readings of FEV1/FVC. Readings will be taken at 1st post op day and after 1st post op week
Modified Borg Dyspnea Scale	1 week	It is a subjective tool to assess degree of dyspnea in patients. The comprise of 10 grades starting from zero to 10. Zero refers to 'No difficulty in breathing at all 'and 10 refers to 'maximal difficulty ' Readings will be taken at 1st post op day and after post op week 1
FEV1	1 week	digital spirometer device will be used to take readings of lung volumes in (ml). These measurements are part of a pulmonary function test, which helps diagnose and monitor respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. Readings will be taken at 1st post op day and after 1st post op week
FVC	1 week	digital spirometer device will be used to take readings of lung capacities in (ml). These measurements are part of a pulmonary function test, which helps diagnose and monitor respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. Readings will be taken at 1st post op day and after 1st post op week
sputum volume	1 Weeks	A sputum collection jar will be used to record the amount of sputum produced by a patient over a specific period of time in (ml). Sputum is a mixture of saliva and mucus that is expectorated from the lungs. By tracking the amount and consistency of sputum, healthcare professionals can monitor the progression of respiratory conditions and assess the effectiveness of treatment.; The readings of these outcome measure will be taken two times. 1st post op day and after 1st week

Secondary Outcome Measures

Name	Time	Method
SaO2 (%)	1 week	pre-post readings will be taken of oxygenic indicators through ABGs
respiratory rate( breaths/minute)	1 week	Pre-post readings of vitals will be taken from monitor attached to the patient
SpO2 (%)	1 week	pre-post readings will be taken of oxygenic indicators through ABGs
blood pressure (mmHg)	1 week	Pre-post readings of vitals will be taken from monitor attached to the patient
body temperature(degree centigrade)	1 week	Pre-post readings of vitals will be taken from monitor attached to the patient
pulse rate (beats/minute)	1 week	Pre-post readings of vitals will be taken from monitor attached to the patient
PaO2 (%)	1 week	pre-post readings will be taken of oxygenic indicators through ABGs
PaCO2 (%)	1 week	pre-post readings will be taken of oxygenic indicators through ABGs

Trial Locations

Locations (1)

Jinnah Hospital; 🇵🇰 Lahore, Punjab, Pakistan