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

Effects of Using Acapella in Combination With Conventional Chest Physiotherapy Techniques to Improve Pulmonary Functions in Post CABG Patients.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Procedure Complication
• Intervention / Treatment: Device: Acapella device; Other: Conventional Treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malik Muhammad Ali Awan, MSPT; Phone Number: 00923339131556; Email: ali.awan@riphah.edu.pk
• Study Contact Backup: Name: Aneeqa Iftikhar, DPT; Phone Number: 00923130876792; Email: aneeqadpt2015@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan
      • Armed forces institute of cardiology
      • Contact: Aneeqa Iftikhar, DPT; Phone Number: 00923130876792; Email: aneeqadpt2015@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Other: Conventional Treatment; Conventional chest physiotherapy techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borg dyspnoea scale	A scale used to measure level of exhaustion, breathlessness and fatigue during physical work. Patients are asked to rate the level of physical exertion, fatigue and dyspnoea on a 6-20 scale where 6 shows no fatigue at all and 20 indicates maximum exertion and fatigue.	6th post-operative day after CABG surgery
Amount of secretions expectorated	tracing the amount of pulmonary secretions produced per day as a result of using respiratory aids along with conventional chest physiotherapy techniques.	6th post-operative day after CABG surgery

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Malik Muhammad Ali Awan, MSPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: REC/MS-PT/01494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No