<?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>IRCT2017010831824N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-06</date_registration>
      <primary_sponsor>Vice chancellor for research Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The impact of sedation protocol on some clinical outcomes of mechanically ventilated patients</public_title>
      <acronym></acronym>
      <scientific_title>The impact of sedation protocol using Richmond Agitation-Sedation Scale (RASS) on some clinical outcomes of mechanically ventilated patients in the Intensive Care Unit (ICU): A Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24944</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomization: All the eligible patients will be included in the study from Feb 2017 to May 2017 (The Poisson simple random sampling). The first five patients will be allocated to the intervention (head) or control (tail) group, and the second five patients will be allocated to the other group (tails) using tossing a coin.</study_design>
      <phase>3</phase>
      <hc_freetext>Sedation.</hc_freetext>
      <i_freetext>Intervention 1: In the proposed protocol, the sedation level of patients will be assessed and recorded using RASS Scale each hour, at the same time of assessment of patients' vital signs by nurses. No particular intervention will be needed if the score is less than -2. If the patient’s Richmond score is between 1 and -1, sedation drugs will be infused just before invasive procedures. However, the patient will receive the appropriate nursing interventions (non-drug interventions) such as repositioning, reducing the endotracheal tube pressure on mouth or nose, reducing environmental noise, etc. if their sedation level score is more than +2. If the patients are sedated, the sedation level will be checked hourly; otherwise, the RASS Scale will be applied and the sedative drugs will be administered according to the patient’s medication order. Intervention 2: The control group will receive the routine treatment and sedation according to the patients' physiological reactions and nurses' clinical judgment to control pain.</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>Zahra Taran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Mousavi Hospital, Gavazang Road, Zanjan, Iran.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956183</zip>
        <telephone>+98 24 3355 2985</telephone>
        <email>zahra.taran93@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Namadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Social Determinants of Health Research Center, Vali-e-Asr Hospital, Sheikh Fazlollah Nouri Freeway, Zanjan, Iran.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45157-77978</zip>
        <telephone>+98 24 3377 0759</telephone>
        <email>m.namadian@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Intubated patient; need to have mechanical ventilation; no addiction (according to patient records and information from patient attendants); Range of age: between 15 and 65; RASS score higher than -3 scores; and GCS score between 5 and 13.&#13;
Exclusion criteria: &#13;
consciousness and extubation during first 24 hours; changing prescribed medicine by the physician; stopping the sedative prescribed medicine; transferring to the operating room; dramatical decrease in the level of patient's consciousness; continuous sedative infusion.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z53, Z53.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Persons encountering health services for specific procedures, not carried out</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>In the proposed protocol, the sedation level of patients will be assessed and recorded using RASS Scale each hour, at the same time of assessment of patients' vital signs by nurses. No particular intervention will be needed if the score is less than -2. If the patient’s Richmond score is between 1 and -1, sedation drugs will be infused just before invasive procedures. However, the patient will receive the appropriate nursing interventions (non-drug interventions) such as repositioning, reducing the endotracheal tube pressure on mouth or nose, reducing environmental noise, etc. if their sedation level score is more than +2. If the patients are sedated, the sedation level will be checked hourly; otherwise, the RASS Scale will be applied and the sedative drugs will be administered according to the patient’s medication order.</i_keyword>
      <i_keyword>The control group will receive the routine treatment and sedation according to the patients' physiological reactions and nurses' clinical judgment to control pain.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of mechanical ventilation. Timepoint: Daily. Method of measurement: Counting hospitalization days.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Death. Timepoint: Daily. Method of measurement: Patient's records.</sec_outcome>
      <sec_outcome>Duration of hospitalization at Intensive Care Unit. Timepoint: At the end of hospitalization at Intensive Care Unit. Method of measurement: Counting the hospitalization days.</sec_outcome>
      <sec_outcome>Transferring from the ICU to the ward. Timepoint: Daily. Method of measurement: Patient's records.</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 Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-03</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research Zanjan University of Medical Sciences, Azadi Square, Zanjan, Iran Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
