<?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>IRCT20190124042482N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-26</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Hyperinflation and Postural Drainage on Respiratory Indices in Mechanical Ventilation Patients</public_title>
      <acronym></acronym>
      <scientific_title>Study of the Effect of Manual Hyperinflation and Postural Drainage on Respiratory Indices in Mechanical Ventilation Patients  in Intensive Care Units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37127</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Other design features: dose not have, Randomization description: Based on inclusion criteria, 80 patients were randomly assigned to the control group (40 cases) and intervention (40cases). Randomization method: block Randomization; randomization unit: Individual; Random layer: not done; Randomization tool: Random sequence generation software (Excel); How to create random sequence: Using random blocks, each block contains 4 people. Assigning a number from 1 to 6 to each block; random allocation hiding: Due to interventions on Unconscious patients, there is no possibility of hiding random assignments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ventilation disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: first day, respiratory parameters ( before routine suctioning and 5, 10 and 25 minutes after Routine suctioning) will be recorded. Then, during the next day before Any time suction, manual dilatation techniques and Postural drainage will be recorded. Then, respiratory parameters (5, 10 and 25 minutes after intervention) will be recorded. Intervention 2: . control group: In the first 24 hours, patients will be suctioned as needed and respiratory parameters (before routine suction and 5, 10 and 25 minutes after routine suctioning) and during the next day, Required suctioning is performed without manual dilatation and postural drainage and respiratory parameters (5, 10 and 25 minutes after suctioning)will be recorded.</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 release plan is still unknown

When:
The release plan is still unknown

To whom:
The release plan is still unknown

Conditions:
The release plan is still unknown

Where to obtain:
The release plan is still unknown

How to obtain:
The release plan is still unknown

Comments:
The release plan is still unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>khatereh seylani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tavid Square, Dr Mirkhani St. (East Nursing), Faculty of Nursing and Midwifery, Faculty of Rehabilitation, Nursing Department of Critical Care</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6691 4368</telephone>
        <email>Kh-seylani@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Navab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tavid Square, Dr Mirkhani St. (East Nursing), Faculty of Nursing and Midwifery, Faculty of Rehabilitation, Nursing Department of Critical Care</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4412</telephone>
        <email>e-navab@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: Patients older than 18 years and less than 60 years old, positive end expiratory pressure 7.5 cm H2O, endotracheal Intubation, attached to ventilator in volumetric mod for 48 hours, stable hemodynamic status, no chest tube, no chest trauma or: pneumothorax, Embolism, subcutaneous emphysema, burns, skin grafts and chest repair surgery, pregnancy, obesity, No use of cardiac pacemaker</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria: receiving mucolytic and diluent drugs (bromoxyn, n-acetylcysteine), cramping drugs, starting, discontinuing or changing bronchodilator expansion agents, changes in mechanical ventilation settings, bronchospasm, Increased intracranial pressure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: first day, respiratory parameters ( before routine suctioning and 5, 10 and 25 minutes after Routine suctioning) will be recorded. Then, during the next day before Any time suction, manual dilatation techniques and Postural drainage will be recorded. Then, respiratory parameters (5, 10 and 25 minutes after intervention) will be recorded</i_keyword>
      <i_keyword>. control group: In the first 24 hours, patients will be suctioned as needed and respiratory parameters (before routine suction and 5, 10 and 25 minutes after routine suctioning) and during the next day, Required suctioning is performed without manual dilatation and postural drainage and respiratory parameters (5, 10 and 25 minutes after suctioning)will be recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>O2saturation. Timepoint: Before, 5, 10 and 25 minutes after suctioning. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before, 5, 10 and 25 minutes after suctioning. Method of measurement: Ventilator monitor.</prim_outcome>
      <prim_outcome>End expiratory co2. Timepoint: Before, 5, 10 and 25 minutes after suctioning. Method of measurement: Capnograph.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-19</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tohid Square, Dr Mirkhani Avenue (East Nursing), Faculty of Nursing and Midwifery, Faculty of Rehabilitation Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
