<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20251101067852N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-13</date_registration>
      <primary_sponsor>College of Nursing /University of Baghdad</primary_sponsor>
      <public_title>The Effect of Acapella and Incentive Spirometry on Blood Gases and Peak Expiratory Flow Rate after Coronary Artery Bypass Graft.</public_title>
      <acronym>A Randomized controlled trial (ARCT),Coronary Artery Bypass Graft (CABG).</acronym>
      <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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/87234</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: The person measuring blood gases.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patient undergoing Coronary Artery Bypass Graft Surgery.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
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:
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:
All the related files will be shared with any scientific interested parties

Conditions:
All the related files will be shared with any scientific interested parties

Where to obtain:
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

How to obtain:
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.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bassima Amir Naji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baghdad, zayona,al Rubaie street</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>10091</zip>
        <telephone>+964 790 188 2421</telephone>
        <email>bassima.a@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad/College of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bassima Amir Naji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baghdad, zayona,al Rubaie street</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>10091</zip>
        <telephone>+964 790 188 2421</telephone>
        <email>bassima.a@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad/College of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
      <country2>Iraq</country2>
    </countries>
    <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.</inclusion_criteria>
      <agemin>33 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <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.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.10 + Z</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>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.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>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.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The authors of the trial are the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-25</approval_date>
        <contact_name>Research Ethical Approval Committee</contact_name>
        <contact_address>College of Nursing/University of Baghdad Bab Al Mua'adham-Baghdad-Iraq P.O.Box:(14149) Baghdad Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
