<?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>IRCT20220618055209N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-23</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of postural drainage on physiological parameters of patients with covid-19 hospitalized in critical care unit</public_title>
      <acronym></acronym>
      <scientific_title>Effect of postural drainage on physiological parameters of patients with covid-19 hospitalized in critical care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64248</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: The study is double-blind. The analysis is done by the analyst and outcome evaluator (two-blind) and the participant. Analysts, evaluators and participants are not aware of the consequences of grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients with Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, patients, in addition to routine ward care, will be placed in special posture evacuation situations and will be used to move pulmonary secretions and direct them to the central airways due to the force of gravity. Positions are performed in three shifts in the morning, evening and night for ten minutes. In each shift, three positions will be performed for the patients. The evening shift will take the position of the arch with a 45-degree angle in the upper body and a 20-degree angle in the waist. The night shift will receive the prone position and the right lateral and left lateral positions at a 45 degree angle to the bed. In each shift, the total positioning time will take a total of 30 minutes. Intervention 2: Control group: In this group, patients will receive routine care in the intensive care unit, including chest physiotherapy.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Seyed Yousef Shahtaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital, Valiasr squre, Shahid Shirodi street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 86 3222 2003</telephone>
        <email>yousef.sh00@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Davood Hekmatpou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Payambar Azam complex, Basij square, Sardasht, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 86 3417 3505</telephone>
        <email>hekmatpou@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Medium to critical grade Covid-19 without intubation with respiratory symptoms
Positive PCR test
Need to receive more than 4 to 6 liters of oxygen per minute with a simple mask with non-rebreathing storage bag
Apache score less than 25
18 to 75 years
Absence of acute asthma, and other lung diseases such as pulmonary edema, heart and lung disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to participate in the study
Do not perform any of the evacuation situations
Intubation during study
Transfer the patient to the ward
Death</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</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>Intervention group: In this group, patients, in addition to routine ward care, will be placed in special posture evacuation situations and will be used to move pulmonary secretions and direct them to the central airways due to the force of gravity. Positions are performed in three shifts in the morning, evening and night for ten minutes. In each shift, three positions will be performed for the patients. The evening shift will take the position of the arch with a 45-degree angle in the upper body and a 20-degree angle in the waist. The night shift will receive the prone position and the right lateral and left lateral positions at a 45 degree angle to the bed. In each shift, the total positioning time will take a total of 30 minutes.</i_keyword>
      <i_keyword>Control group: In this group, patients will receive routine care in the intensive care unit, including chest physiotherapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breathing rate. Timepoint: Before and immediately after each intervention. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Oxygen saturation percentage. Timepoint: Before and immediately after each intervention. Method of measurement: Pulse oximetry.</prim_outcome>
      <prim_outcome>Blood carbon dioxide pressure. Timepoint: At the beginning and end of the study. Method of measurement: Venous blood gas sample test.</prim_outcome>
      <prim_outcome>Blood pH. Timepoint: At the beginning and end of the study. Method of measurement: Venous blood gas sample test.</prim_outcome>
      <prim_outcome>Blood bicarbonate. Timepoint: At the beginning and end of the study. Method of measurement: Venous blood gas sample test.</prim_outcome>
      <prim_outcome>Need to get oxygen. Timepoint: Immediately after the intervention, one hour after each intervention and the day after the last intervention. Method of measurement: Physical examination.</prim_outcome>
      <prim_outcome>Number of coughs. Timepoint: Up to one hour after the end of each intervention and the next day at the end of the intervention time. Method of measurement: Physical examination.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-28</approval_date>
        <contact_name>Ethics comittee of Arak University of Medical Sciences</contact_name>
        <contact_address>Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
