Cardiac Procedure ComplicationNCT05856032
Effects of Acapella With Conventional Chest Physiotherapy Techniques in Post CABG Patients.
A study testing Acapella device and Conventional Treatment in people with Cardiac Procedure Complication, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Cardiac Procedure Complication
- What is being tested?
- Acapella device and Conventional Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Cardiology
Rawalpindi, Punjab Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Procedure Complication
- Being tested
- Acapella device, Conventional Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella deviceDevice
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 TreatmentOther
Conventional chest physiotherapy techniques
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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%.
Measured: pre-operative day 1 and post-operative day 6 of CABG surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6th post-operative day after CABG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Jun 2023
- Primary completion1 Oct 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Procedure ComplicationStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Muhammad Ali Awan, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856032
- Sponsor's protocol ID
- REC/MS-PT/01494
- Status last verified
- May 2024
- First submitted
- 4 May 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using Acapella in Combination With Conventional Chest Physiotherapy Techniques to Improve Pulmonary Functions in Post CABG Patients.
- ClinicalTrials.gov ID
- NCT05856032
- Acronym / sponsor ID
- REC/MS-PT/01494
- Conditions
- Cardiac Procedure Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of Acapella device | Experimental | Device: 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. |
| Conventional treatment | Active comparator | Other: 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acapella deviceAcapella 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. | Device | Use of Acapella device |
| Conventional TreatmentConventional chest physiotherapy techniques | Other | Conventional treatment |
Primary outcome
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
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
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%.
2 secondary outcomes
Borg dyspnoea scale
Time frame: 6th post-operative day after CABG surgery
Amount of secretions expectorated
Time frame: 6th post-operative day after CABG surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malik Muhammad Ali Awan, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella device and Conventional Treatment in people with Cardiac Procedure Complication, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Forced Expiratory Volume in 1 second (time frame: pre-operative day 1 and post-operative day 6 of CABG surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.