<?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>IRCT201610129469N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-22</date_registration>
      <primary_sponsor>Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>The effects of using Richmond Sedation, Agitation Scale on the length of stay and mechanical ventilation in ICU patients</public_title>
      <acronym></acronym>
      <scientific_title>The effects of using Richmond Sedation-Agitation Scale on the length of stay and mechanical ventilation in ICU patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>103</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10047</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Table of random numbers.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Head trauma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: As soon as a patient gets anxious and agitated and every 6 hours by using Richmond sedation-agitation protocol, their level of sedation and agitation during monitoring under ventilator will be measured by the researcher and then the final score will be informed to the anesthesia specialist of the ward.Then, he will order or change the type and dosage of the sedative drugs for the patient based on the scores , if necessary. Intervention 2: Control group: non-use of Richmond protocol, receive routine care.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Adineh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3554 2036</telephone>
        <email>mohadineh@gmail.com; adineh-m@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Adineh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan st, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3554 2036</telephone>
        <email>mohadineh@gmail.com; adineh-m@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The patient with brain truma is intubated and under ventilator; GCS score of ≥ 4; Not using neuromuscular blocker drugs ; The patient's age is between 16 -65 years old; Patient not be hyper active delirium with the physician diagnosis; Patient has no contraindications to the use of midazolam, lorazepam and propofol drugs.&#13;
 Exclusion criteria: Lack of family consent for the patient participation in the study; The patient transferred to other centers during the study; Patient takes neuromuscular blocker drugs during the study; Patient becomes hyperactive delirium during the study; Making a contraindication for using one of the midazolam, lorazepam and propofol drugs by the patient during the study; Patient agitation is not relieved by Richmond protocol during the study.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S06.3, S06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Focal brain injury, Epidural hemorrhage, Traumatic subdural hemorrhage, Traumatic subarachnoid hemorrhage, Intracranial injury with prolonged coma, Other intracranial injuries, Intracranial injury, unspecified</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: As soon as a patient gets anxious and agitated and every 6 hours by using Richmond sedation-agitation protocol, their level of sedation and agitation during monitoring under ventilator will be measured by the researcher and then the final score will be informed to the anesthesia specialist of the ward.Then, he will order or change the type and dosage of the sedative drugs for the patient based on the scores , if necessary.</i_keyword>
      <i_keyword>Control group: non-use of Richmond protocol, receive routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hospitalization period in ICU. Timepoint: Number of days hospitalized. Method of measurement: Checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dependence on mechanical ventilation period. Timepoint: Number of days dependence on mechanical ventilation. Method of measurement: Checklist.</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>Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-23</approval_date>
        <contact_name>Ethics Committee of  Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee, Vice chancellor for research,  Ahvaz Jundishapur University of Medical Sciences. Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
