- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07337746
The Effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate After Coronary Artery Bypass Graft.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Baghdad, Iraq
- Ibn AL-Betar Teaching Hospital
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Baghdad, Iraq
- Iraqi Center of Heart Disease
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acapella (oscilatory PEP)
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.
|
Acapella is a vibration-driven respiratory therapy device that breaks up mucus and promotes airway secretions.
|
|
Experimental: Incentive Spirometry
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.
|
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.
|
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No Intervention: Routin Care
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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as baseline one day before surgery (pre-intervention) and post intervention in three consecutive days after surgery.
|
|
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
|
as a baseline (pre-intervention) one day before surgery and three consecutive days after surgery and post-intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Acapella Device
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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