<?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>IRCT20130812014333N259</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-01</date_registration>
      <primary_sponsor>Islamic Azad University, Khorasgan Branch</primary_sponsor>
      <public_title>Investigating the effect of incentive spirometry and breathing exercises on pulmonary complications</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of incentive spirometry and breathing exercises on pulmonary complications and the duration of hospitalization of patients undergoing coronary heart transplant surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84561</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the simple random method. The names of the participants are written on the card. The cards are put into a box that cannot be seen from outside. One of the colleagues of the plan is asked to remove one card from the container at a time. The names of the 22 cards that are selected first are placed in the first intervention group, the second 22 selected cards are placed in the first control group, and the remaining 22  in the second control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary Artery Bypass surgery.</hc_freetext>
      <i_freetext>Intervention 1: In the first intervention group, incentive spirometry and breathing exercises will be performed two days before surgery and after surgery until admission to the ICU. Incentive spirometry will be performed in the form of 10 deep breaths every two hours, in the morning and evening shifts (12 hours) in a sitting or semi-sitting position. After completing inhalation, the patient holds their breath for 3 to 5 seconds and then, by removing the device, exhales slowly through the mouth. Deep breathing exercises include deep inhalation, effective coughing, and diaphragmatic breathing. To cough effectively, the patient coughs five times with maximum strength every hour while awake and rests for 30 seconds after each cough. Intervention 2: In the second intervention group, it will be performed only after the operation until the time of hospitalization in the ICU. It will be performed according to a regular schedule. Incentive spirometry will be performed in the form of 10 deep breaths every two hours, in the morning and evening shifts (12 hours) in a sitting or semi-sitting position. After completing inhalation, the patient holds their breath for 3 to 5 seconds and then, by removing the device, exhales slowly through the mouth. Deep breathing exercises include deep inhalation, effective coughing, and diaphragmatic breathing. To cough effectively, the patient coughs five times with maximum strength every hour while awake and rests for 30 seconds after each cough. Intervention 3: In the control group, no intervention will be performed and patients are cared for regularly according to the ward's routine schedule.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sina Omidifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>sinaomidifar98@gmail.com</email>
        <affiliation>Islamic Azad University, Khorasgan Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Marziyeh Ziaeirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>M.ziaeirad@yahoo.com</email>
        <affiliation>Islamic Azad University, Khorasgan branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent
Over 18 years old
Mechanical ventilation less than 24 hours after surgery
Ability to perform breathing exercises and use incentive spirometry</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of neuromuscular and cognitive disorders
History of preoperative pulmonary disorders such as chronic obstructive pulmonary disease (COPD), asthma, severe chest infection, and pulmonary tuberculosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of aortocoronary bypass graft</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first intervention group, incentive spirometry and breathing exercises will be performed two days before surgery and after surgery until admission to the ICU. Incentive spirometry will be performed in the form of 10 deep breaths every two hours, in the morning and evening shifts (12 hours) in a sitting or semi-sitting position. After completing inhalation, the patient holds their breath for 3 to 5 seconds and then, by removing the device, exhales slowly through the mouth. Deep breathing exercises include deep inhalation, effective coughing, and diaphragmatic breathing. To cough effectively, the patient coughs five times with maximum strength every hour while awake and rests for 30 seconds after each cough.</i_keyword>
      <i_keyword>In the second intervention group, it will be performed only after the operation until the time of hospitalization in the ICU. It will be performed according to a regular schedule. Incentive spirometry will be performed in the form of 10 deep breaths every two hours, in the morning and evening shifts (12 hours) in a sitting or semi-sitting position. After completing inhalation, the patient holds their breath for 3 to 5 seconds and then, by removing the device, exhales slowly through the mouth. Deep breathing exercises include deep inhalation, effective coughing, and diaphragmatic breathing. To cough effectively, the patient coughs five times with maximum strength every hour while awake and rests for 30 seconds after each cough.</i_keyword>
      <i_keyword>In the control group, no intervention will be performed and patients are cared for regularly according to the ward's routine schedule.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: From the time of hospitalization to the day of discharge. Method of measurement: Atelectasis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Atelectasis. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Using radiography.</sec_outcome>
      <sec_outcome>Pleural effusion. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Using radiography.</sec_outcome>
      <sec_outcome>Pneumonia. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Using radiography.</sec_outcome>
      <sec_outcome>Pneumothorax. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Using radiography.</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>Islamic Azad University, Khorasgan Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-19</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Khorasgan branch</contact_name>
        <contact_address>Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
