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NCT Number: NCT05856032

Effects of Acapella With Conventional Chest Physiotherapy Techniques 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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed Forces Institute of Cardiology

Rawalpindi, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

conventional treatment

Other

Conventional chest physiotherapy techniques

Primary outcomes

  1. Change in Forced Expiratory Volume in 1 second

    Time frame: pre-operative day 1 and post-operative day 6 of CABG surgery

    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

  2. Change in Forced Vital Capacity

    Time frame: pre-operative day 1 and post-operative day 6 of CABG surgery

    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

  3. Ratio of Forced Expiratory Volume in 1 second and Forced Vital Capacity

    Time frame: pre-operative day 1 and post-operative day 6 of CABG surgery

    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%.

Secondary outcomes

  1. Borg dyspnoea scale

    Time frame: 6th post-operative day after CABG surgery

    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.

  2. Amount of secretions expectorated

    Time frame: 6th post-operative day after CABG surgery

    tracing the amount of pulmonary secretions produced per day as a result of using respiratory aids along with conventional chest physiotherapy techniques.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 12, 2023
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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