<?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>IRCT20181031041518N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-23</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of removing the chest tube  in the end of expiration  on the severity of pain and pulmonary complications after  surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of removal of chest tube at the end of the exhalation on the severity of pain and pulmonary complications after coronary artery bypass graft surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35001</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: Quasi- Experimental study, Randomization description: In the present study, the patients were registered according to the sample size (120) and according to theinclusion criteria, and using the blocking method (using a two-block method, two letters A and B with different permutations we place blocks in blocks and randomly select 60 blocks and assign each block to 2 people) will be assigned to two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Atherosclerotic heart disease.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: In this study, patients are randomly placed under the outflow of the thoracic tube at the end of exhalation. The sampling procedure continues to complete the number of samples. When the researcher said that the patient drew a breath of 2 - 3 deeply breaths and exhaled a deep breath during the outflow of the chest tube (a Valsalva maneuver at the end of exhalation). It receives if it is prescribed for a patient with a narcotic drug. The intensity of pain in the thoracic cavity, the severity of the shortness of breath and the amount of spo2 is measured over the three-time frame: immediately after - 15 minutes and 1 hour after the chest tube pipeline is removed. To measure pneumothorax 1 hour after the departure the chest tube (chest x-ray) and compared with the last CXR of the patient before the extubation of the chest tube by a specialist. Intervention 2: Control group:  Includes patients who routinely withdraw from the chest tube at the tail end (performing valsalva maneuver at the tail end). In this group, all the above tutorials are also given, the variables are recorded at the same time but at the end of the tail and compared to the end of the results.</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:
Individual data of participants after unidentifiable individuals; and the main implications of the study.

When:
After completing the study.

To whom:
Researchers working in scientific institutions

Conditions:
Researchers working in scientific institutions

Where to obtain:
00988133115516

How to obtain:
Refer to the email: a.gohari@edo.umsha.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akbar Gohari Kamel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fahmideh BIvd- Opposite the People's Park-Hamedan University of Medical Sciences- School of Nursing and Midwifery.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65178-38698</zip>
        <telephone>+98 81 3311 5516</telephone>
        <email>a.gohari@edo.umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Salavati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fahmideh BIvd - Opposite the People's Park-Hamedan University of Medical Sciences- School of Nursing and Midwifery.</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65178-38698</zip>
        <telephone>+98 81 3838 0447</telephone>
        <email>salavatimohsen42@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Awful patients undergoing coronary artery bypass graft surgery by cardiopulmonary bypass method
Having two chest drainage chambers at the same distance to each other
At least 24 hours have passed since the tubes were imported.
Lack of diabetes and neuropathies caused by other diseases
Ability to speak and understand Persian language
Lack of hearing impairment
Having hemodynamic stability (systolic blood pressure greater than 90 mmHg, lack of dangerous dysrhythms)</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Valve Replacement Surgery
Patients undergoing cardiac emergency surgery
Patients with diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: In this study, patients are randomly placed under the outflow of the thoracic tube at the end of exhalation. The sampling procedure continues to complete the number of samples. When the researcher said that the patient drew a breath of 2 - 3 deeply breaths and exhaled a deep breath during the outflow of the chest tube (a Valsalva maneuver at the end of exhalation). It receives if it is prescribed for a patient with a narcotic drug. The intensity of pain in the thoracic cavity, the severity of the shortness of breath and the amount of spo2 is measured over the three-time frame: immediately after - 15 minutes and 1 hour after the chest tube pipeline is removed. To measure pneumothorax 1 hour after the departure the chest tube (chest x-ray) and compared with the last CXR of the patient before the extubation of the chest tube by a specialist.</i_keyword>
      <i_keyword>Control group:  Includes patients who routinely withdraw from the chest tube at the tail end (performing valsalva maneuver at the tail end). In this group, all the above tutorials are also given, the variables are recorded at the same time but at the end of the tail and compared to the end of the results.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Immediately before, immediately after, 15 minutes and an hour after the chest tube exits. Method of measurement: VAS(Visual  Analogue  Scale).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dyspnea. Timepoint: Immediately before, immediately after, 15 minutes and an hour after the chest tube exits. Method of measurement: Borg's Facilitated Criterion.</sec_outcome>
      <sec_outcome>Amount of spo2. Timepoint: Immediately before, immediately after, 15 minutes and an hour after the chest tube exits. Method of measurement: Monitor device available on the patient's bedside.</sec_outcome>
      <sec_outcome>Pneumothorax. Timepoint: َAn hour after the chest tube exits. Method of measurement: Chest X-ray.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-12</approval_date>
        <contact_name>Ethics Committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>BIvd fahmideh-Opposite the People's Park-Hamedan University of Medical Sciences-School of Nursing and Midwifery Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
