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

Cardiac Procedure Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05856032
• Other study ID #: REC/MS-PT/01494
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: February 2024

Study information

• Verified date: May 2023
• Source: Riphah International University
• Contact: Malik Muhammad Ali Awan, MSPT
• Phone: 00923339131556
• Email: ali.awan[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: February 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Procedure Complication

Intervention

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.

Other:
• Conventional Treatment
Conventional chest physiotherapy techniques

Locations

Country	Name	City	State
Pakistan	Armed Forces Institute of Cardiology	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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