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

NCT05856032 | Completed DMC

• 1 other identifier: REC/MS-PT/01494
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Procedure Complication

Outcome Measures

Primary Outcomes (3)

• Change in Forced Expiratory Volume in 1 second

  Forced expiratory volume in 1 second, measures the volume of air that is expired into the mouthpiece of the digital spirometer in first second after full inhalation. Normally ranges between 80% to 120% of average predicted values

  pre-operative day 1 and post-operative day 6 of CABG surgery

• Change in Forced Vital Capacity

  FVC: forced vital capacity, measures the volume of air blown forcefully into the mouthpiece following full inhalation. Normal values ranges between 80% to 120% of average predicted values

  pre-operative day 1 and post-operative day 6 of CABG surgery

• Ratio of Forced Expiratory Volume in 1 second and Forced Vital Capacity

  FEV1/FVC: the FEV1/FVC ratio is calculated by dividing measured FEV1 value by measured FVC value. In a healthy individual it ranges between 70 to 85%.

  pre-operative day 1 and post-operative day 6 of CABG surgery

Secondary Outcomes (2)

• Borg dyspnoea scale

  6th post-operative day after CABG surgery

• Amount of secretions expectorated

  6th post-operative day after CABG surgery

Study Arms (2)

Use of Acapella device

EXPERIMENTAL

* 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.

Device: Acapella device

Conventional treatment

ACTIVE COMPARATOR

•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.

Other: Conventional Treatment

Interventions

Acapella device 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.

Use of Acapella device

Conventional Treatment OTHER

Conventional chest physiotherapy techniques

Conventional treatment

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Armed Forces Institute of Cardiology

Rawalpindi, Punjab Province, Pakistan

Location

Study Officials

• Malik Muhammad Ali Awan, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded as they won't be knowing in which intervention group they are allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: June 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)