Post Opeative Pulmonary ComplicationNCT07337746
The Effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate After Coronary Artery Bypass Graft.
A study testing Incentive Spirometry therapy and Acapella therapy in people with Post Opeative Pulmonary Complication, run by University of Baghdad at 2 sites in Iraq.
Trial summary
The goal of this clinical trial is to learn if whether the Acapella and Incentive Spirometry have effect on Blood Gas and Peak Expiratory Flow Rate among patients undergoing Coronary Artery Bypass Graft Surgery. Read more about this study
- Who is it for?
- Ages 33 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Opeative Pulmonary Complication
- What is being tested?
- Incentive Spirometry therapy and Acapella therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIraq
- Study dates
- 1 Sep 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 33 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A patient who is an adult admitted to the hospital for coronary artery bypass graft surgery after receiving a diagnosis of coronary artery disease.
- Been between 33 years and 60 years old.
- being open to taking part in the research and giving informed permission.
Who cannot join
- individuals having a body mass index (BMI) between 16 and 28 kg/m2.
- patients who have asthma or COPD.
- patients that need reintubation.
- patients who have history of respiratory tract infection.
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
Ibn AL-Betar Teaching Hospital
Baghdad
Iraqi Center of Heart Disease
Baghdad
About this study
Official title: The Effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate After Coronary Artery Bypass Graft: A Randomized Controlled Trial
The goal of this clinical trial is to learn if whether the Acapella and Incentive Spirometry have effect on Blood Gas and Peak Expiratory Flow Rate among patients undergoing Coronary Artery Bypass Graft Surgery. the main question it aims to answer is:
- What is the most effect of using a capella versus incentive spirometry on blood gas parameters (pao2 and paco2) and Peak Expiratory Flow Rate in patient undergoing coronary artery bypass grafting?
- is the incentive spirometry have effect on blood gases parameters and Peak Expiratory Flow Rate?
- is the Acapella have effect on blood gas parameters and Peak Expiratory Flow Rate? Researcher will Compare the Level of Blood gases and Peak Expiratory Flow Rate between Coronary Artery Bypass Graft patients who receive Acapella and Incentive Spirometry and those who do not receive it to see if the Acapella and the Incentive Spirometry work to enhance the level of blood gases parameters and Peak Expiratory Flow Rate. participant will take Acapella and incentive Spirometry on day before surgery and for three days after Surgery for 10-15 min for each session two times a day.
Read the detailed description
Heart disease has now been eclipsed by cardiovascular diseases as India's leading cause of mortality. The estimated worldwide disease burden surpasses the global average of 235 deaths per 100,000 people, with age-standardized CVD mortality rates of 272 per 100,000. The prevalence of coronary artery disease is on the rise throughout Southeast Asia, with India leading the way in recent years.
CABG is the median sternotomy is the method most frequently used to accomplish it. The process known as "grafting" involves taking a vein or internal mammary artery 3 and placing it both close to and far from the lesion.
The most vulnerable time following surgery is the early postoperative period. The reduction in lung function continues for several months following surgery.
In order to prevent or reduce complications including pneumonia, atelectasis, pulmonary insufficiency, sputum collection, and decreased gas exchange, chest physical therapy has traditionally been a basic part of postoperative care.
Patients undergoing CABG are commonly advised to perform breathing exercises, either with or without mechanical devices, in order to prevent or minimize lung deterioration. A variety of chest physiotherapy techniques are available. These include cough support, early mobilization, posture, incentive spirometry (IS), deep breathing exercises, respiratory muscles, and active cycle breathing techniques (ACBT).
Acapella is a vibration-driven respiratory therapy device that breaks up mucus and promotes airway secretions. It is another method that is frequently utilized. The apparatus can be utilized in any orientation, whether sitting, standing, or lying down, contingent upon the patient's breathing gravity. Acapella Selection is useful. People with lung disease and issues with their excretory system have wide airways. Easily disassembled for improvement, this device is a tremendous asset. The frequency and real resistance of this sludge remover can also be adjusted. In less than half of a natural chest physiotherapy session, patients' management times can also be completed. The Acapella device does not need to be removed by patients while they are using it.
In a variety of clinical contexts, there have been numerous papers demonstrating the benefits of alternate vibration and oscillation on lung function and air outflow. Acapella is made out of a metal bar attached to a handle and magnet, as well as an anti-weight cover. The cause of the oscillation in airflow is the occasional cessation of airflow through the plug, which breaks and repairs the magnetic attraction.
The goal of incentive spirometry is to get the patient to inhale fully, simulate unrestricted yawning or groaning, increase or maintain lung volume, and facilitate the ejection of phlegm.
As a result, the usage of practical tools to facilitate secretory discharge is increasing. Different technologies that support current physiotherapy approaches in increasing mobilization and secretory release have emerged in recent years. Written report focusing on the effectiveness of Acapella as a tool to help with secretion clearance in various lung diseases.
The adverse effects of general anesthesia, intubation, and analgesia on mucociliary clearance following surgery are well documented. When lung volumes are reduced, as they are during the postoperative period, coughing will be less effective since expiratory flow rate is directly correlated with lung volume.
In order to maintain postoperative CABG status, respiratory physiotherapy is essential. Physiotherapists utilize interventions such early mobilization, effective coughing techniques, postoperative breathing exercises, and inspiratory muscle training to promote oxygenation following open heart surgery and minimize lung volume declines and atelectasis.
- Conditions
- Post Opeative Pulmonary Complication
- Being tested
- Incentive Spirometry therapy, Acapella therapy
- Keywords
- Spirometry, Acapella, peak Expiratory Flow Rate, Arterial Blood Gases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive Spirometry therapyDevice
is a device that computes the amount of air that is inspired into the lungs. By causing a piston inside the device to raise when breathing in, an incentive spirometer measures the volume of inspired air.
Acapella therapyDevice
Acapella is a vibration-driven respiratory therapy device that breaks up mucus and promotes airway secretions.
| Study group | Role | What they receive |
|---|---|---|
| Acapella (oscilatory PEP) | Experimental | Experimental group will take Acapella for 10-15 minutes per session, two times per a day for 2 days before surgery and 3 days after CABG operation. Receives: Device: Acapella therapy |
| Incentive Spirometry | Experimental | Experimental group will not be exposed to Acapella and take only Incentive Spirometry for 10-15 minutes per session, 2 times per a day for 2 days before surgery and three consecutive days after CABG Surgery. Receives: Device: Incentive Spirometry therapy |
| Routin Care | No intervention | control group will not be exposed to Acapella or Incentive Spirometry and will take only routine care like breathing exercise, huffing, coughing and manual percussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow Rate (PEFR)
For improvement in expiratory airflow indicating lung function recovery
Measured: as baseline one day before surgery (pre-intervention) and post intervention in three consecutive days after surgery.
Arterial Blood Gases (ABG)
we see the change in Arterial Blood Gases value before and after intervention
Measured: as a baseline (pre-intervention) one day before surgery and three consecutive days after surgery and post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Sep 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Opeative Pulmonary ComplicationStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Model description
- The study design in the present study was a randomized controlled trial (RCT) design was used in this study to investigate the effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate after Coronary Artery Bypass Graft: A Randomized Controlled Trial. RCT is a quantitative, true experimental, and comparative study executed under controlled conditions, in which interventions are randomly allocated to different groups in order to minimize bias and determine a cause-effect relationship between an intervention and an outcome. the population was patients from two cardiac centers selected based on eligibility criteria the. This was achieved through a simple random sampling probability method using two cards. The white card represents the participant included in the study group, and the black card represents patients control the study sample. This method provides researchers with the opportunity to select participants for the study randomly and without bias.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassima Amir Naji Omar Hilmi, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337746
- Sponsor's protocol ID
- Acapella Device
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate After Coronary Artery Bypass Graft: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07337746
- Acronym / sponsor ID
- Acapella Device
- Conditions
- Post Opeative Pulmonary Complication
- Keywords
- Spirometry, Acapella, peak Expiratory Flow Rate, Arterial Blood Gases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Jan 2026 (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 goal of this clinical trial is to learn if whether the Acapella and Incentive Spirometry have effect on Blood Gas and Peak Expiratory Flow Rate among patients undergoing Coronary Artery Bypass Graft Surgery. the main question it aims to answer is:
- What is the most effect of using a capella versus incentive spirometry on blood gas parameters (pao2 and paco2) and Peak Expiratory Flow Rate in patient undergoing coronary artery bypass grafting?
- is the incentive spirometry have effect on blood gases parameters and Peak Expiratory Flow Rate?
- is the Acapella have effect on blood gas parameters and Peak Expiratory Flow Rate? Researcher will Compare the Level of Blood gases and Peak Expiratory Flow Rate between Coronary Artery Bypass Graft patients who receive Acapella and Incentive Spirometry and those who do not receive it to see if the Acapella and the Incentive Spirometry work to enhance the level of blood gases parameters and Peak Expiratory Flow Rate. participant will take Acapella and incentive Spirometry on day before surgery and for three days after Surgery for 10-15 min for each session two times a day.
Detailed description
Heart disease has now been eclipsed by cardiovascular diseases as India's leading cause of mortality. The estimated worldwide disease burden surpasses the global average of 235 deaths per 100,000 people, with age-standardized CVD mortality rates of 272 per 100,000. The prevalence of coronary artery disease is on the rise throughout Southeast Asia, with India leading the way in recent years.
CABG is the median sternotomy is the method most frequently used to accomplish it. The process known as "grafting" involves taking a vein or internal mammary artery 3 and placing it both close to and far from the lesion.
The most vulnerable time following surgery is the early postoperative period. The reduction in lung function continues for several months following surgery.
In order to prevent or reduce complications including pneumonia, atelectasis, pulmonary insufficiency, sputum collection, and decreased gas exchange, chest physical therapy has traditionally been a basic part of postoperative care.
Patients undergoing CABG are commonly advised to perform breathing exercises, either with or without mechanical devices, in order to prevent or minimize lung deterioration. A variety of chest physiotherapy techniques are available. These include cough support, early mobilization, posture, incentive spirometry (IS), deep breathing exercises, respiratory muscles, and active cycle breathing techniques (ACBT).
Acapella is a vibration-driven respiratory therapy device that breaks up mucus and promotes airway secretions. It is another method that is frequently utilized. The apparatus can be utilized in any orientation, whether sitting, standing, or lying down, contingent upon the patient's breathing gravity. Acapella Selection is useful. People with lung disease and issues with their excretory system have wide airways. Easily disassembled for improvement, this device is a tremendous asset. The frequency and real resistance of this sludge remover can also be adjusted. In less than half of a natural chest physiotherapy session, patients' management times can also be completed. The Acapella device does not need to be removed by patients while they are using it.
In a variety of clinical contexts, there have been numerous papers demonstrating the benefits of alternate vibration and oscillation on lung function and air outflow. Acapella is made out of a metal bar attached to a handle and magnet, as well as an anti-weight cover. The cause of the oscillation in airflow is the occasional cessation of airflow through the plug, which breaks and repairs the magnetic attraction.
The goal of incentive spirometry is to get the patient to inhale fully, simulate unrestricted yawning or groaning, increase or maintain lung volume, and facilitate the ejection of phlegm.
As a result, the usage of practical tools to facilitate secretory discharge is increasing. Different technologies that support current physiotherapy approaches in increasing mobilization and secretory release have emerged in recent years. Written report focusing on the effectiveness of Acapella as a tool to help with secretion clearance in various lung diseases.
The adverse effects of general anesthesia, intubation, and analgesia on mucociliary clearance following surgery are well documented. When lung volumes are reduced, as they are during the postoperative period, coughing will be less effective since expiratory flow rate is directly correlated with lung volume.
In order to maintain postoperative CABG status, respiratory physiotherapy is essential. Physiotherapists utilize interventions such early mobilization, effective coughing techniques, postoperative breathing exercises, and inspiratory muscle training to promote oxygenation following open heart surgery and minimize lung volume declines and atelectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study design in the present study was a randomized controlled trial (RCT) design was used in this study to investigate the effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate after Coronary Artery Bypass Graft: A Randomized Controlled Trial. RCT is a quantitative, true experimental, and comparative study executed under controlled conditions, in which interventions are randomly allocated to different groups in order to minimize bias and determine a cause-effect relationship between an intervention and an outcome. the population was patients from two cardiac centers selected based on eligibility criteria the. This was achieved through a simple random sampling probability method using two cards. The white card represents the participant included in the study group, and the black card represents patients control the study sample. This method provides researchers with the opportunity to select participants for the study randomly and without bias.
| Arm | Type | Receives |
|---|---|---|
| Acapella (oscilatory PEP) | Experimental | Device: Acapella therapyExperimental group will take Acapella for 10-15 minutes per session, two times per a day for 2 days before surgery and 3 days after CABG operation. |
| Incentive Spirometry | Experimental | Device: Incentive Spirometry therapyExperimental group will not be exposed to Acapella and take only Incentive Spirometry for 10-15 minutes per session, 2 times per a day for 2 days before surgery and three consecutive days after CABG Surgery. |
| Routin Care | No intervention | –control group will not be exposed to Acapella or Incentive Spirometry and will take only routine care like breathing exercise, huffing, coughing and manual percussion |
Who may qualify
- Ages
- 33 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A patient who is an adult admitted to the hospital for coronary artery bypass graft surgery after receiving a diagnosis of coronary artery disease.
- Been between 33 years and 60 years old.
- being open to taking part in the research and giving informed permission.
Key exclusion criteria (4 listed)
- individuals having a body mass index (BMI) between 16 and 28 kg/m2.
- patients who have asthma or COPD.
- patients that need reintubation.
- patients who have history of respiratory tract infection.
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 |
|---|---|---|
| Incentive Spirometry therapyis a device that computes the amount of air that is inspired into the lungs. By causing a piston inside the device to raise when breathing in, an incentive spirometer measures the volume of inspired air. | Device | Incentive Spirometry |
| Acapella therapyAcapella is a vibration-driven respiratory therapy device that breaks up mucus and promotes airway secretions. | Device | Acapella (oscilatory PEP) |
Primary outcome
Peak Expiratory Flow Rate (PEFR)
Time frame: as baseline one day before surgery (pre-intervention) and post intervention in three consecutive days after surgery.
For improvement in expiratory airflow indicating lung function recovery
Arterial Blood Gases (ABG)
Time frame: as a baseline (pre-intervention) one day before surgery and three consecutive days after surgery and post-intervention.
we see the change in Arterial Blood Gases value before and after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Spirometry therapy and Acapella therapy in people with Post Opeative Pulmonary Complication, run by University of Baghdad at 2 sites in Iraq.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. 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?
This study is still under way. Results are not available in the source record yet.
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?
Peak Expiratory Flow Rate (PEFR) (time frame: as baseline one day before surgery (pre-intervention) and post intervention in three consecutive days after surgery.). The study lists 2 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 13 Jan 2026.