The Effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate after Coronary Artery Bypass Graft: A Randomized Controlled Trial
1. To Evaluate the effect of incentive spirometry on Blood Gases and Peak Expiratory Flow Rate (PEFR) for patients after Coronary Artery Bypass Graft Surgery.
2. To Evaluate the effect of Acapella on Blood Gases and Peak Expiratory Flow Rate (PEFR) for patients after Coronary Artery Bypass Graft Surgery.
3. To compare the effect of incentive spirometry versus Acapella on Peak Expiratory Flow Rate (PEFR) and Blood Gases among patients with coronary artery bypass surgery.
Design
The study design in the present study was a randomized controlled trial (RCT), parallel, single blinded.
Settings and conduct
Surgical word and intensive care units of tow cardiac centrs in Iraq .Baghdad.Single blinded throughout the study
Participants/Inclusion and exclusion criteria
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.
Intervention groups
intervention group (A) 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.Intervention group (B) 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.
Main outcome variables
Peak Expiratory Flow Rate (PEFR)
Description: For improvement in expiratory airflow indicating lung function recovery
Time Frame: as baseline one day before surgery (pre-intervention) and post intervention in three consecutive days after surgery.
General information
Reason for update
Acronym
A Randomized controlled trial (ARCT),Coronary Artery Bypass Graft (CABG).
IRCT registration information
IRCT registration number:IRCT20251101067852N1
Registration date:2025-11-13, 1404/08/22
Registration timing:registered_while_recruiting
Last update:2025-11-13, 1404/08/22
Update count:0
Registration date
2025-11-13, 1404/08/22
Registrant information
Name
Bassima Amir
Name of organization / entity
Baghdad University
Country
Iraq
Phone
+964 1 778 8501
Email address
bassima.a@conursing.uobaghdad.edu.iq
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-11-10, 1404/08/19
Expected recruitment end date
2026-07-01, 1405/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific 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
Public title
The Effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate after Coronary Artery Bypass Graft.
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 33 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person measuring blood gases
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee
Street address
College of Nursing/University of Baghdad Bab Al Mua'adham-Baghdad-Iraq P.O.Box:(14149)
City
Baghdad
Postal code
(14149)
Approval date
2025-03-25, 1404/01/05
Ethics committee reference number
37
Health conditions studied
1
Description of health condition studied
patient undergoing Coronary Artery Bypass Graft Surgery
ICD-10 code
I25.10 + Z
ICD-10 code description
This code indicates chronic ischemic heart disease caused by atherosclerosis (plaque buildup) in one or more native coronary arteries.The patient does not experience angina pectoris (chest pain) at the time of diagnosis.
Primary outcomes
1
Description
Peak Expiratory Flow Rate (PEFR) For improvement in expiratory airflow indicating lung function recovery
Timepoint
as baseline one day before surgery (pre-intervention) and post intervention in three consecutive days after surgery.
Method of measurement
Peak flow meter
2
Description
Arterial Blood Gases (ABG) we see the change in Arterial Blood Gases value before and after intervention
Timepoint
as a baseline (pre-intervention) one day before surgery and three consecutive days after surgery and post-intervention.
Method of measurement
Blood Gas Analyzer
Secondary outcomes
1
Description
Peripheral Oxygen Saturation
Timepoint
as baseline one day before surgery (pre-intervention) and post intervention in three consecutive days after surgery.
Method of measurement
Pulse oximetey before and after breathing exercises
Intervention groups
1
Description
Intervention group: Acapella (oscilatory PEP) Experimental group will take Acapella for 10-15 minutes per session, two times per a day for 1 days before surgery and 3 days after CABG operation.
Category
Treatment - Devices
2
Description
Intervention group: 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 1 days before surgery and three consecutive days after CABG Surgery.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Iraqi Center of Heart Disease, Baghdad,
Full name of responsible person
Bassima Amir Naji
Street address
Baghdad Medical City (Daira Madinat Al‑Tib), Bab al‑Muadham, Baghdad, Iraq
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The authors of the trial are the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad/College of Nursing
Full name of responsible person
Bassima Amir Naji
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Baghdad, zayona,al Rubaie street
City
Baghdad
Province
Alrusafa
Postal code
10091
Phone
+964 790 188 2421
Email
bassima.a@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad/College of Nursing
Full name of responsible person
Bassima Amir Naji
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Baghdad, zayona,al Rubaie street
City
Baghdad
Province
Al Rusafa
Postal code
10091
Phone
+964 790 188 2421
Email
bassima.a@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
College of Nursing of Baghdad
Full name of responsible person
Bassima Amir Naji
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Baghdad, zayona
City
Baghdad
Province
Alrusafa
Postal code
10064
Phone
+964 790 188 2421
Email
bassima.a@conursing.uobaghdad.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. Sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
once finishing the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for 6 months after the publications, after you are approved to register on the Iranian clinical trials website
To whom data/document is available
All the related files will be shared with any scientific interested parties
Under which criteria data/document could be used
All the related files will be shared with any scientific interested parties
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscipt can be used to contact the author.E-mail bassima.a@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
The processes involved in accessing this documentation are possible via email :bassima.a@conursing.uobaghdad.edu.iq, the first and last name of authors, trial' title variable and the trial Id.
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors. The three groups were added individually in each field. We hope that the modifications will be appropriate to the design of the experiment. With many thanks and appreciation for your patience.