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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05856032
Other study ID # REC/MS-PT/01494
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date February 1, 2024

Study information

Verified date May 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 66
Est. completion date February 1, 2024
Est. primary completion date October 1, 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.

Study Design


Related Conditions & MeSH terms


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
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