<?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>IRCT20210424051061N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-29</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of continuous and biphasic positive airway pressure in patients with Covid</public_title>
      <acronym>cbpapc</acronym>
      <scientific_title>Comparison of the effect of continuous positive airway pressure )CPAP) and biphasic Positive Airway Pressure (BiPAP) on hemodynamic parameters in covid-19 patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55790</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: In this study, first, individuals are entered into the study in an accessible manner based on inclusion and exclusion criteria, and then using permutation blocks in two groups, CPAP mask and BIPAP mask will be allocated. In this method, if we consider the cpap group A, the bipap group B, the 6 possible states will be in the 4 blocks AABB-BBAA-ABAB-BABA-BAAB-ABBA, which will be assigned a number for each block and each The load will be selected by lot and patients will enter the study, respectively, Blinding description: In this study, participants, health care personnel (physicians, nurses, physiotherapists, etc.) who are responsible for patient care, used the allocation of the device and did not know the purpose of the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this research, the CPAP device of Saadat and venet manufacturers is used. Using an air pump, the CPAP device transmits airflow to the patient at a pressure set by the mask. The device settings are adjusted by a physician or specialist based on the information contained in the sleep test. These settings include parameters such as the number of apneas; Adjustable pressure range: 20 - 4 cm water; Pressure adjustment: 3 - 0 cm of water; Adjustable initial pressure by the patient; Device settings with buttons; LED lights on the device; Storing, calculating and retrieving information is like the average total treatment hours. Intervention 2: Intervention group: In this research, the BIPAP device of Fisher and Resmed manufacturers is used, which includes a humidifier chamber-hose and mask whose settings include IPAP-EPAP (IPAP applies maximum pressure at the time of inhalation and EPAP minimum pressure at the time of Exhale).</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:
All data is potentially shareable after unidentified individuals

When:
After completing the plan

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
For research

Where to obtain:
Researcher email address

How to obtain:
Researcher email address

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Kokab Basiri Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9P67+R29,Imam Khomeini street, Gonabad, Razavi Khorasan Province</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5722351322</zip>
        <telephone>+98 51 5722 3513</telephone>
        <email>k.basiri@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Kokab Basiri Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9P67+R29, Gonabad, Imam Khomeini street, Razavi Khorasan Province</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5722351322</zip>
        <telephone>+98 51 5722 3513</telephone>
        <email>k.basiri@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Age 20 -60 y/o
No history of cardiovascular disease such as hypertension, liver, kidney according to self-declaration
Need to prescribe oxygen and candidate for non-invasive respiratory assistance (NIV) according to physician (no need for intubation)
No ban on the use of masks
Definitive diagnosis of coronavirus infection by physician and laboratory results</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Need to intubate the patient immediately
Awareness level based on the Glasgow scale less than 15
Any change in the patient's condition that affects the course of treatment, for example blood pressure below 90 mmhg despite fluid therapy or the use of vasopressors</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this research, the CPAP device of Saadat and venet manufacturers is used. Using an air pump, the CPAP device transmits airflow to the patient at a pressure set by the mask. The device settings are adjusted by a physician or specialist based on the information contained in the sleep test. These settings include parameters such as the number of apneas; Adjustable pressure range: 20 - 4 cm water; Pressure adjustment: 3 - 0 cm of water; Adjustable initial pressure by the patient; Device settings with buttons; LED lights on the device; Storing, calculating and retrieving information is like the average total treatment hours.</i_keyword>
      <i_keyword>Intervention group: In this research, the BIPAP device of Fisher and Resmed manufacturers is used, which includes a humidifier chamber-hose and mask whose settings include IPAP-EPAP (IPAP applies maximum pressure at the time of inhalation and EPAP minimum pressure at the time of Exhale).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean score of hemodynamic parameters. Timepoint: Before the mask is prescribed, it will be examined by a person immediately after use and after 1 hour, 6 hours and then daily for up to 3 days at a specific time. Method of measurement: Patient-connected monitoring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean oxygen saturation, mean blood pressure, mean pulse rate. Timepoint: Based on the monitor attached to the patient before the mask is administered, immediately after use and after 1 hour, 6 hours and then daily for up to 3 days at a specific time will be examined by one person. Method of measurement: Patient-connected monitoring device.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Vice Chancellor for Research, Gonabad University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Gonabad University of Medical Sciences</source_name>
      <source_name>Vice Chancellor for Research, Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-21</approval_date>
        <contact_name>Ethics committee of gonabad University of Medical Sciences</contact_name>
        <contact_address>9P67+R29,Imam Khomeini street, Gonabad, Razavi Khorasan Province Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
