Coronary Artery Bypass Graft SurgeryNCT05260944
Power Lung Versus Acapella After Coronary Artery Bypass Graft Surgery
A study testing Acapella device, Power lung device and routine Physical Therapy program in people with Coronary Artery Bypass Graft Surgery, run by South Valley University at 1 site in Egypt.
Trial summary
The purpose of the study is to compare between the power lung versus acapella on airway clearance after coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery
- What is being tested?
- Acapella device, Power lung device and routine Physical Therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2021to 5 Aug 2023
- 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 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- They will be from 40-50 years old.
- They will be patients undergo elective CABG surgery.
- Non productive cough postoperatively.
- Cough pain intensity > 5 as rated on a visual analogue scale (VAS) on postoperative day 1.
Who cannot join
- Patients with chronic chest diseases.
- Patients with an intensive postoperative care (ICU) stay > 48 hrs.
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Power Lung Versus Acapella on Airway Clearance After Coronary Artery Bypass Graft Surgery
The purpose of the study is to compare between the power lung versus acapella on airway clearance after coronary artery bypass graft surgery.
Read the detailed description
In this part of the study the materials and methods will be presented under the following headings: subjects, equipments, procedures of the study and statistical procedures
- Subjects. Ninty patients of both sexes will participate in this study with an age range of 40 to 50 years old. They will be chosen from outpatient clinic, Qena University Hospital. Patients will be randomely assigned into three groups: Group A: patients will receive a two supervised sessions using acapella device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration. Group B: patients will receive a two supervised session using power lung device three sets for 10 repetitions two times daily from first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, Percussion and vibration). Group C. Patients will receive only routine physical Therapy program.
- Equipment:
- For evaluation: Arterial blood gases including: - paO2, paCO2, PH and O2 saturation. Spirometry measurements: - as forced vital capacity (FVC) andbforced expiratory volume in the first second (FEV1).
The incidence of PPCs and the length of postoperative stay: - using the Melbourne Group Scale Dyspnea. According to the revised or modified Borg scale or rating of perceived exersion.
The Rand SF 36 health survey questionnaire. 2. For treatment The power lung device. Acapella device.
- Conditions
- Coronary Artery Bypass Graft Surgery
- Being tested
- Acapella device, Power lung device, routine Physical Therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella deviceDevice
patients will receive a two supervised sessions using acapella device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration.
Power lung deviceDevice
Group B. patients will receive a two supervised sessions using power lung device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration.
routine Physical Therapy programOther
Group C. Thirty patients will receive only routine physical Therapy program
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A. Thirty patients will receive a two supervised session using Acapella three sets for 10 repetitions two times daily from first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, Percussion and vibration). Receives: Device: Acapella device |
| Group B | Experimental | Thirty patients will receive a two supervised sessions using power lung device three sets for 10 repetitions from the first day postoperative until 7 days(André L.et al., 2016), in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration). Receives: Device: Power lung device |
| Group C | Active comparator | Thirty patients will receive only routine physical Therapy program. Receives: Other: routine Physical Therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood gases including:
Partial pressure of oxygen (paO2), partial pressure of carbon dioxide (paCO2), power of hydrogen (PH)and O2 saturation.
Measured: One week
Secondary outcomes (1)
Spirometry
As forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and the FEV1/FVC.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 Aug 2021
- Primary completion5 Jul 2023 (estimated)
- Study completion5 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study three groups of patients will participated first, group A. Will receive acapella device. Second, group B. Will receive power lung device. Third, group C. Will receive only routine physical Therapy program.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa yussuf abo zaid, South Valley University
- Investigators
- Shymaa Y Abo zaid, Master, Principal investigator, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260944
- Sponsor's protocol ID
- P.T.REC/012/002682
- Status last verified
- Apr 2023
- First submitted
- 8 Feb 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Lung Versus Acapella on Airway Clearance After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT05260944
- Acronym / sponsor ID
- P.T.REC/012/002682
- Conditions
- Coronary Artery Bypass Graft Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 5 Jul 2023 (estimated)
- Study completion
- 5 Aug 2023 (estimated)
- First posted
- 2 Mar 2022 (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.
The purpose of the study is to compare between the power lung versus acapella on airway clearance after coronary artery bypass graft surgery.
Detailed description
In this part of the study the materials and methods will be presented under the following headings: subjects, equipments, procedures of the study and statistical procedures
- Subjects. Ninty patients of both sexes will participate in this study with an age range of 40 to 50 years old. They will be chosen from outpatient clinic, Qena University Hospital. Patients will be randomely assigned into three groups: Group A: patients will receive a two supervised sessions using acapella device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration. Group B: patients will receive a two supervised session using power lung device three sets for 10 repetitions two times daily from first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, Percussion and vibration). Group C. Patients will receive only routine physical Therapy program.
- Equipment:
- For evaluation: Arterial blood gases including: - paO2, paCO2, PH and O2 saturation. Spirometry measurements: - as forced vital capacity (FVC) andbforced expiratory volume in the first second (FEV1).
The incidence of PPCs and the length of postoperative stay: - using the Melbourne Group Scale Dyspnea. According to the revised or modified Borg scale or rating of perceived exersion.
The Rand SF 36 health survey questionnaire. 2. For treatment The power lung device. Acapella device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- In the study three groups of patients will participated first, group A. Will receive acapella device. Second, group B. Will receive power lung device. Third, group C. Will receive only routine physical Therapy program.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Acapella deviceGroup A. Thirty patients will receive a two supervised session using Acapella three sets for 10 repetitions two times daily from first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, Percussion and vibration). |
| Group B | Experimental | Device: Power lung deviceThirty patients will receive a two supervised sessions using power lung device three sets for 10 repetitions from the first day postoperative until 7 days(André L.et al., 2016), in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration). |
| Group C | Active comparator | Other: routine Physical Therapy programThirty patients will receive only routine physical Therapy program. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- They will be from 40-50 years old.
- They will be patients undergo elective CABG surgery.
- Non productive cough postoperatively.
- Cough pain intensity > 5 as rated on a visual analogue scale (VAS) on postoperative day 1.
Key exclusion criteria (3 listed)
- Patients with chronic chest diseases.
- Patients with an intensive postoperative care (ICU) stay > 48 hrs.
- Uncooperative patients.
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 devicepatients will receive a two supervised sessions using acapella device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration. | Device | Group A |
| Power lung deviceGroup B. patients will receive a two supervised sessions using power lung device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration. | Device | Group B |
| routine Physical Therapy programGroup C. Thirty patients will receive only routine physical Therapy program | Other | Group C |
Primary outcome
Arterial blood gases including:
Time frame: One week
Partial pressure of oxygen (paO2), partial pressure of carbon dioxide (paCO2), power of hydrogen (PH)and O2 saturation.
1 secondary outcome
Spirometry
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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.
Shymaa Y Abo zaid, Master principal investigator
Assistant lecturer
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, Power lung device and routine Physical Therapy program in people with Coronary Artery Bypass Graft Surgery, run by South Valley University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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 Egypt. 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?
Results are not available in the source record.
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?
Arterial blood gases including: (time frame: One week). 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 Apr 2023.