Effects of Acapella With Conventional Chest Physiotherapy Techniques in Post CABG Patients.

NCT ID: NCT05856032

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-02-01

Brief Summary

To determine the effects of using Acapella as an oscillatory positive expiratory pressure device in combination with conventional chest physiotherapy for secretion removal and revival of pulmonary functions in hospitalized post coronary artery bypass grafting patients.

Detailed Description

Acapella is one of the Oscillatory Positive Expiratory Pressure (OPEP) device used in mobilization of peripheral secretions to the central trachea. It consists of a mouth piece and metal strip that is attached to a magnet which oscillates upon exhalation of the patient into the device results in oscillations. This helps in generating positive expiratory pressure (PEP) and oscillations of the magnetic ball assist in mucus collection and expectoration. Pulmonary functions are greatly reduced in patients undergone CABG surgery due to prolong effects of anesthesia and muscle relaxants administered prior to surgery. Ciliary motion along the pathway of pulmonary tract is depressed which results in decrease expectoration capacity, causes mucus retention and reduces pulmonary volumes and capacities. Chest physiotherapy is the treatment option for such patients that is being practiced over years. In recent years certain respiratory aids or devices are also in use to relieve secretion retention along with standard chest physiotherapy techniques.

The purpose of this study is to find the effects of using Acapella as an OPEP device along with conventional chest physiotherapy techniques in post-CABG surgery patients to relieve mucus retention and improving pulmonary functions post-surgery.

Conditions

Cardiac Procedure Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Use of Acapella device

• Experimental group will receive treatment with Acapella device twice a day for 6 days post-operatively.
• Participants in this group will also receive conventional chest physiotherapy protocol as: incentive spirometry, Active Cycles of Breathing Technique (ACBT), Diaphragmatic breathing exercises except manual chest physiotherapy techniques.

Group Type: EXPERIMENTAL

Acapella device

Intervention Type: DEVICE

Acapella is one of the Oscillatory Positive Expiratory Pressure (OPEP) device used in mobilization of peripheral secretions to the central trachea. It consists of a mouth piece and metal strip that is attached to a magnet which oscillates upon exhalation of the patient into the device results in oscillations. This helps in generating positive expiratory pressure (PEP) and oscillations of the magnetic ball assist in mucus collection and expectoration. Pulmonary functions are greatly reduced in patients undergone CABG surgery due to prolong effects of anaesthesia and muscle relaxants administered prior to surgery.

Conventional treatment

•Participants in control or comparative group will receive conventional chest physiotherapy protocol as incentive spirometry, ACBT's, Diaphragmatic breathing exercises along with manual chest physiotherapy techniques as percussion and vibration.

Group Type: ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type: OTHER

Conventional chest physiotherapy techniques

Interventions

Acapella device

Acapella is one of the Oscillatory Positive Expiratory Pressure (OPEP) device used in mobilization of peripheral secretions to the central trachea. It consists of a mouth piece and metal strip that is attached to a magnet which oscillates upon exhalation of the patient into the device results in oscillations. This helps in generating positive expiratory pressure (PEP) and oscillations of the magnetic ball assist in mucus collection and expectoration. Pulmonary functions are greatly reduced in patients undergone CABG surgery due to prolong effects of anaesthesia and muscle relaxants administered prior to surgery.

Intervention Type: DEVICE

Conventional Treatment

Conventional chest physiotherapy techniques

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients of both genders within age range of 45-65 years
• Elective CABG surgery patients
• Patients undergoing Phase 1 cardiac rehabilitation post CABG
• Patients who are vitally stable post operatively

Exclusion Criteria

• Patient having prolong intubation period post-operatively
• Patients having long term arrythmias prior to surgery
• Patients having an implanted pacemaker
• Patients having uncontrolled diabetes, sepsis or any metabolic condition
• Patients with impaired cognition.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malik Muhammad Ali Awan, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Armed Forces Institute of Cardiology

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/MS-PT/01494

Identifier Type: -

Identifier Source: org_study_id