<?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>IRCT20231101059927N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-07</date_registration>
      <primary_sponsor>PNS Shifa Karachi</primary_sponsor>
      <public_title>HACOR score in predicting non-invasive ventilation failure</public_title>
      <acronym></acronym>
      <scientific_title>Using HACOR score in predicting failure of non-invasive ventilation in patient with Type-I respiratory failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73588</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic, Blinding description: Blinded of the study protocol and given a standard monitoring chart to endorse vitals and clinical variables to be later assessed by the outcome assessor.</study_design>
      <phase>2</phase>
      <hc_freetext>Type-I respiratory failure.</hc_freetext>
      <i_freetext>Intervention group: HACOR SCORE GROUP.</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:
Word document of the manuscript along with output sheet of SPSS software would be made available

When:
After acceptance for publication, data will be available online indefinitely

To whom:
Academic and research institutes only

Conditions:
For research, academic and teaching purposes only

Where to obtain:
Will be available online through google drive

How to obtain:
A written request to the primary author and the institute training branch and after acceptance and permission data would be made available in the next 5 working days and a temporary google drive link will be shared to download the data in the next one week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Aftab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dha phase 2</address>
        <city>Karachi</city>
        <country1>Pakistan</country1>
        <zip>24700</zip>
        <telephone>+92 300 2509354</telephone>
        <email>alijiwani512@hotmail.com</email>
        <affiliation>PNS Shifa Hospital Karachi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Aftab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dha phase 2</address>
        <city>Karachi</city>
        <country1>Pakistan</country1>
        <zip>24700</zip>
        <telephone>+92 300 2509354</telephone>
        <email>alijiwani512@hotmail.com</email>
        <affiliation>PNS Shifa Hospital Karachi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with Pa02/FiO2 levels &lt; 300 mmHg and PaCO2 levels less than 45 mmHg with PaO2 and PaCO2 (calculated by ABG (arterial blood gas) analysis) at room air or not maintaining ratio at low oxygenation therapy after administration of oxygen at FiO2 of 0.30</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with severe cardiorespiratory compromise
Critical patients on vasopressor support
Patients with poor lung compliance unable to breath in CPAP
Intubated patients or those intubated less than 1 hour of CPAP
Patients with a previous failed CPAP trial or on HFNO (high flow nasal oxygenation) in the last 72 hours
Patients non-compliant on CPAP despite sedation
Patients unwilling to be included in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J96.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute respiratory failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Early detection</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: HACOR SCORE GROUP</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Failure of NIV after 1-hour on CPAP therapy. Timepoint: 1 hour after CPAP therapy. Method of measurement: Standard HACOR score.</prim_outcome>
      <prim_outcome>Sensitivity and specificity of HACOR in predicting NIV failure. Timepoint: 1 hour after being on CPAP therapy. Method of measurement: Assessment using standard SPSS software.</prim_outcome>
      <prim_outcome>Postive and negative predictive value of the HACOR test in assessing NIV failure. Timepoint: 1  hour after being on CPAP therapy. Method of measurement: Standard statistical SPSS software.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate and mean arterial pressure. Timepoint: Before and after 1 hour of CPAP therapy. Method of measurement: Cardiac monitor.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Before and after 1 hour of CPAP therapy. Method of measurement: Standard respiratory monitor.</sec_outcome>
      <sec_outcome>Glasgow coma scale. Timepoint: Before and after 1 hour of CPAP therapy. Method of measurement: Standard Glasgow coma scale.</sec_outcome>
      <sec_outcome>Pa02/FiO2 ratio. Timepoint: Before and after 1 hour of CPAP therapy. Method of measurement: Using arterial blood gas samples and standard calculating formula.</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>PNS Shifa Karachi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-30</approval_date>
        <contact_name>Ethical Review Board PNS Shifa Karachi</contact_name>
        <contact_address>PNS Shifa Karachi Sindh Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
