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Completed

NCT Number: NCT06317363

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

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

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Key information

Conditions

CABG Dyspnea Infections Lung Diseases Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Atelectasis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Hospital

Lahore, Punjab Province, 54600, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Base Line + ACEPELLA

Other

Group A (baseline treatment + acapella) consisting of 15 participants will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella). The primary and secondary outcome measures will be assessed at baseline post-op day 1, and after 1 week of surgery.

Base Line + Manual Chest Physiotherapy

Other

The group B consisting of 15 participants will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute. The s primary and secondary outcome measures will be assessed at baseline post-op day 1, and after 1 week of surgery.

Primary outcomes

  1. Modified Borg Dyspnea Scale

    Time frame: 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

  2. FEV1

    Time frame: 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

  3. FVC

    Time frame: 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

  4. FEV1/FVC

    Time frame: 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

  5. sputum volume

    Time frame: 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 outcomes

  1. body temperature(degree centigrade)

    Time frame: 1 week

    Pre-post readings of vitals will be taken from monitor attached to the patient

  2. pulse rate (beats/minute)

    Time frame: 1 week

    Pre-post readings of vitals will be taken from monitor attached to the patient

  3. respiratory rate( breaths/minute)

    Time frame: 1 week

    Pre-post readings of vitals will be taken from monitor attached to the patient

  4. blood pressure (mmHg)

    Time frame: 1 week

    Pre-post readings of vitals will be taken from monitor attached to the patient

  5. SpO2 (%)

    Time frame: 1 week

    pre-post readings will be taken of oxygenic indicators through ABGs

  6. SaO2 (%)

    Time frame: 1 week

    pre-post readings will be taken of oxygenic indicators through ABGs

  7. PaO2 (%)

    Time frame: 1 week

    pre-post readings will be taken of oxygenic indicators through ABGs

  8. PaCO2 (%)

    Time frame: 1 week

    pre-post readings will be taken of oxygenic indicators through ABGs

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Acapella VS Chest Physiotherapy on Dyspnea, Pulmonary Functions and Air Way Clearance in Post-Operative CABG Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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