<?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>IRCT20191030045281N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-25</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison the effect of applying “expiratory rib cage compression” and “manual percussion” before suction on respiratory parameters</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of applying “expiratory rib cage compression” and “manual percussion” before suction on respiratory parameters in patients under  mechanical ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43562</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Group A is a group that will be carried out first by manual percussion and then  expiratory rib cage compression. Group B group that will be performed first by expiratory rib cage compression and then manual percussion .
The letter A is written on 23 cards and the letter B on the other 23 cards. One of these two cards is randomly selected for each patient. Patients with card A enter Group A and patients with card B enter Group B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients under mechanical ventilation.</hc_freetext>
      <i_freetext>Intervention 1: Group A is the group that will do the manual percussion first and then expiratory rib cage compression. In the manual percussion procedure, the hands are cupped and all fingers are folded and the wrist joint is opened and performed at speeds of 100 to 120 times per minute. In the expiratory rib cage compression,gradually compressed the end and lateral parts of patients’ rib cage during expiration by his hands. This technique was bilaterally performed, and in the end of expiration, the compression was released from the patients’ rib cage to let them have a free inspiration. Both interventions will be performed by the researcher in one day with a 3-hour interval (to neutralize the previous intervention), respectively. Respiratory parameters: increased end-expiratory CO2, pulmonary compliance and hemoglobin saturation, and respiratory rate and airway resistance in patients undergoing mechanical ventilation in the ICU will be assessed before and 1, 5 and 25 minutes after endotracheal suctioning. Intervention 2: Group B is the group that first will do the expiratory rib cage compression and then manual percussion before the suction. In the manual percussion procedure, the hands are cupped and all fingers are folded and the wrist joint is opened and performed at speeds of 100 to 120 times per minute.  In the expiratory rib cage compression,gradually compressed the end and lateral parts of patients’ rib cage during expiration by his hands. This technique was bilaterally performed, and in the end of expiration, the compression was released from the patients’ rib cage to let them have a free inspiration. Both interventions will be performed by the researcher in one day with a 3-hour interval (to neutralize the previous intervention), respectively. Respiratory parameters: increased end-expiratory CO2, pulmonary compliance and hemoglobin saturation, and respiratory rate and airway resistance in patients undergoing mechanical ventilation in the ICU will be assessed before and 1, 5 and 25 minutes after endotracheal suctioning.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Rasuli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Narges 5 Suleiman Bag Street 37</address>
        <city>Baneh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66918-64496</zip>
        <telephone>+98 87 3424 0418</telephone>
        <email>maryam.rasuli@muk.ac.ir</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Fathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences Campus, Pasdaran Ave, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13446</zip>
        <telephone>+98 87 3366 4653</telephone>
        <email>fathi_sanan@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>intubated patients
Patients under mechanical ventilation with volumetric mode
For at least 48 hours under mechanical ventilation
not needing more than 2 times suction per shift
patients with stable hemodynamic parameters
reversible gastric secretion less than 100 ml before Intervention
Age between 18 and 65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Respiratory distress
pneumothorax and Fractures of the ribs, sternum and chest
chest burns and surgery
dysrhythmia and heart disease
Abscess and lung cyst</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>Group A is the group that will do the manual percussion first and then expiratory rib cage compression. In the manual percussion procedure, the hands are cupped and all fingers are folded and the wrist joint is opened and performed at speeds of 100 to 120 times per minute. In the expiratory rib cage compression,gradually compressed the end and lateral parts of patients’ rib cage during expiration by his hands. This technique was bilaterally performed, and in the end of expiration, the compression was released from the patients’ rib cage to let them have a free inspiration. Both interventions will be performed by the researcher in one day with a 3-hour interval (to neutralize the previous intervention), respectively. Respiratory parameters: increased end-expiratory CO2, pulmonary compliance and hemoglobin saturation, and respiratory rate and airway resistance in patients undergoing mechanical ventilation in the ICU will be assessed before and 1, 5 and 25 minutes after endotracheal suctioning.</i_keyword>
      <i_keyword>Group B is the group that first will do the expiratory rib cage compression and then manual percussion before the suction. In the manual percussion procedure, the hands are cupped and all fingers are folded and the wrist joint is opened and performed at speeds of 100 to 120 times per minute.  In the expiratory rib cage compression,gradually compressed the end and lateral parts of patients’ rib cage during expiration by his hands. This technique was bilaterally performed, and in the end of expiration, the compression was released from the patients’ rib cage to let them have a free inspiration. Both interventions will be performed by the researcher in one day with a 3-hour interval (to neutralize the previous intervention), respectively. Respiratory parameters: increased end-expiratory CO2, pulmonary compliance and hemoglobin saturation, and respiratory rate and airway resistance in patients undergoing mechanical ventilation in the ICU will be assessed before and 1, 5 and 25 minutes after endotracheal suctioning.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>End Tidal CO2. Timepoint: Exhaled CO2 is measured 4 times: before and minutes 1, 5 and 25  minutes after endotracheal suctioning. Method of measurement: Using Capnography Probe.</prim_outcome>
      <prim_outcome>Oxygen saturation (SPO2). Timepoint: Oxygen saturation (SPO2) is measured 4 times: before and minutes 1, 5 and 25 minutes after endotracheal suction. Method of measurement: Using a pulse oximeter device (via monitor view).</prim_outcome>
      <prim_outcome>Pulmonary compliance. Timepoint: Pulmonary compliance is measured 4 times: before and minutes 1, 5 and 25 minutes after endotracheal suction. Method of measurement: Through viewing the ventilator screen.</prim_outcome>
      <prim_outcome>Airway resistance. Timepoint: Airway resistance measured 4 times: before and minutes 1, 5 and 25 minutes after endotracheal suction. Method of measurement: Through viewing the ventilator screen.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Respiratory rate is measured 4 times: before and minutes 1, 5 and 25 minutes after endotracheal suction. Method of measurement: Total spontaneous breathing and ventilator-provided breathing per minute by viewing the ventilator screen.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-14</approval_date>
        <contact_name>Ethics committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences Campus, Pasdaran Ave, Sanandaj Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
