<?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>IRCT20171212037848N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-06</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the Effect of Using the T-pieace Method among patients with head trauma</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the clinical outcomes of the T-piece and pressure support ventilation among patients with head trauma: a randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43905</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were randomly allocated to the intervention and a control groups through block randomization method using blocks of size 4.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Head trauma patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients in the intervention group were placed on the T-piece for two hours. Patients who did not tolerate spontaneous breathing were reconnected to MV , were considered as unsuccessful weaning, and were subjected to another weaning attempt 24 hours after the first attempt. Spontaneous breathing toleration criteria were respiratory rate of less than 35 per minutes, heart rate of less than 140 beats per minute, arterial oxygen saturation of more than 90%, arterial partial oxygen pressure of more than 60 mm Hg, and no symptom of increased respiration workload such as sweating, dyspnea, and use of accessory respiratory muscles . Patients who fulfilled the criteria of spontaneous breathing for two hours were considered as successful weaning and were subjected to extubation. After extubation, patients who did not need re-intubation for 48 hours were considered as successful extubation. Intervention 2: Control group: In the control group, patients who fulfilled weaning criteria were placed on  pressure support ventilation (PSV) with a pressure support of less than 8 mm Hg. If patients tolerated spontaneous breathing for two hours were considered as successful weaning and were subjected to extubation; otherwise, they were considered as unsuccessful weaning and placed on synchronized intermittent mandatory ventilation (SIMV). Patients with successful weaning and extubation were considered as successful extubation if they did not need re-intubation during the first 48 hours after extubation.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is a decision to publish the article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sareh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar boulevard</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15315-34199</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>sareh_mohammadi@ymail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sareh Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar boulevard</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15315-34199</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>s.mohammadi@qms.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients hospitalized in intensive care units
Received mechanical ventilation for at least 48 hours and at most two weeks
Age of more than 18 years old
Glasgow Coma Scale (GCS) score of more than 9
Normal electrolyte levels
Hemoglobin greater than 8
Body temperature less than 38.5</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>chronic disease and cardiopulmonary problem
intake of vasoactive medications
spinal cord injury
history of convulsion
Poisoning-induced altered consciousness</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients in the intervention group were placed on the T-piece for two hours. Patients who did not tolerate spontaneous breathing were reconnected to MV , were considered as unsuccessful weaning, and were subjected to another weaning attempt 24 hours after the first attempt. Spontaneous breathing toleration criteria were respiratory rate of less than 35 per minutes, heart rate of less than 140 beats per minute, arterial oxygen saturation of more than 90%, arterial partial oxygen pressure of more than 60 mm Hg, and no symptom of increased respiration workload such as sweating, dyspnea, and use of accessory respiratory muscles . Patients who fulfilled the criteria of spontaneous breathing for two hours were considered as successful weaning and were subjected to extubation. After extubation, patients who did not need re-intubation for 48 hours were considered as successful extubation</i_keyword>
      <i_keyword>Control group: In the control group, patients who fulfilled weaning criteria were placed on  pressure support ventilation (PSV) with a pressure support of less than 8 mm Hg. If patients tolerated spontaneous breathing for two hours were considered as successful weaning and were subjected to extubation; otherwise, they were considered as unsuccessful weaning and placed on synchronized intermittent mandatory ventilation (SIMV). Patients with successful weaning and extubation were considered as successful extubation if they did not need re-intubation during the first 48 hours after extubation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weaning of mechanical ventilation. Timepoint: During the hospital stay. Method of measurement: Examine the vital signs of the patient.</prim_outcome>
      <prim_outcome>Extubation. Timepoint: During the hospital stay. Method of measurement: Examine the vital signs of the patient.</prim_outcome>
      <prim_outcome>Duration of mechanical ventilation. Timepoint: After the weaning of mechanical ventilation. Method of measurement: Number of days the patient is under mechanical ventilation.</prim_outcome>
      <prim_outcome>Length of hospital stay. Timepoint: Weaning time until hospital discharge. Method of measurement: Number of days of hospitalization.</prim_outcome>
      <prim_outcome>Death rate. Timepoint: Time of death. Method of measurement: Number of deaths in two groups.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-19</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Bahonar boulevard Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
