<?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>IRCT20100921004787N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-19</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Survey effect of manual percussion and mechanical vibration on respiratory indexes in mechanically ventilated patients in Rasht Poursina hospital critical care units 2019- 2020</public_title>
      <acronym></acronym>
      <scientific_title>Survey effect of manual percussion and mechanical vibration on respiratory indexes in mechanically ventilated patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45193</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Specimens are assigned randomly to quadruple blocks in order to select the sequence of intervention in groups A and B, which will be sequenced using" Random block " software. The proprietary Randomized Allocation is kept in a sealed package with the ward supervisor. And before starting the intervention will open. Based on the daily and inpatient referrals in the section according to the sequence of samples will be divided into groups A and B. Group A is the group which first receive manual percussion and after the wash out period  mechanical vibration is performed on them and Group B is the group that is first mechanical vibration performed after the washout period 
 recieve manual percussion, Blinding description: participant. They do not know the order of the interventions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chest physiotherapy.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: or group A: the group that first received manual percussion and after wash out period mechnical vibration perform on them .one hour after  suction and before the intervention started ,the indices like pulmonary compliance and airway resistance seen on the ventilator screen is recorded as well as the percentage of arterial oxygen saturation from the monitor next to the patient's bed. Indicators are recorded immediately after each intervention, and at 1, 5, 15 and 30 minutes after each intervention. Intervention 2: Intervention group: the group that first received mechanical vibration  and after wash out period manual percussion perform on them .one hour after suction and before  intervention started ,the indices like pulmonary compliance and airway resistance seen on the ventilator screen is recorded as well as the percentage of arterial oxygen saturation from the monitor next to the patient's bed. Indicators are recorded immediately after each intervention, and at 1, 5, 15 and 30 minutes after each intervention.</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 Once the data collection is complete, the decision will be made</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Rasoulnis</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Student of Nursing and Midwifery Faculty, Shahid Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 3302</telephone>
        <email>nasim.msn2014@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Khaleghdoost Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Student of Nursing and Midwifery Faculty, Shahid Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 3202</telephone>
        <email>khaleghdoost@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Connected to mechanical ventilation
Complete cardiopulmonary monitoring
Hemodynamic stability in the last 6 hours according to anesthesiologist
Absence of spinal cord injuries
No pulmonary disease and no pneumothorax, hemothorax and rib fracture
Recurrent volume of gastric lavage less than 100 ml before intervention</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hemodynamic parameters instability
Increased intracranial pressure
The need for emergency suctioning during the intervention
Changes in ventilator device settings and modes during the study
Patient leaving the ward to perform paraclinical procedures and withdraw from monitoring</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>First Intervention group: or group A: the group that first received manual percussion and after wash out period mechnical vibration perform on them .one hour after  suction and before the intervention started ,the indices like pulmonary compliance and airway resistance seen on the ventilator screen is recorded as well as the percentage of arterial oxygen saturation from the monitor next to the patient's bed. Indicators are recorded immediately after each intervention, and at 1, 5, 15 and 30 minutes after each intervention.</i_keyword>
      <i_keyword>Intervention group: the group that first received mechanical vibration  and after wash out period manual percussion perform on them .one hour after suction and before  intervention started ,the indices like pulmonary compliance and airway resistance seen on the ventilator screen is recorded as well as the percentage of arterial oxygen saturation from the monitor next to the patient's bed. Indicators are recorded immediately after each intervention, and at 1, 5, 15 and 30 minutes after each intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pulmonary compliance. Timepoint: Before intervention and 1, 5, 15, 30 minutes after intervention in each group. Method of measurement: View on ventilator screen.</prim_outcome>
      <prim_outcome>Airway resistance. Timepoint: Before intervention and 1, 5, 15, 30 minutes after intervention in each group. Method of measurement: View on ventilator screen.</prim_outcome>
      <prim_outcome>Percentage of arterial blood oxygen saturation. Timepoint: Before intervention and 1, 5, 15, 30 minutes after intervention in each group. Method of measurement: From the monitoring screen connected to the patient.</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>Guilan university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-18</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Student of Nursing and Midwifery Faculty, Shahid Beheshti Highway, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
