<?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>IRCT20181113041632N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-26</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Nursing Interventions based on Bern's tool on the success rate of Weaning</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of Nursing Interventions based on Bern's tool on the success rate of Weaning</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35188</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: The method of assigning intervention to patients was randomized and random blocked blocks with block size 4 (using the table for random permutations). A randomized list is provided by a statistician. The interrogation used in this study is based on a randomized list by a person outside the study who is not aware of the research objectives and will be conducted according to the different codes in the sealed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Traumatic patients connected to a mechanical ventilation device. Condition 2: Traumatic patients connected to a mechanical ventilation device. Condition 3: Traumatic patients connected to a mechanical ventilation device. Condition 4: Traumatic patients connected to a mechanical ventilation device.</hc_freetext>
      <i_freetext>Intervention 1: Nurses will plan and conduct nursing care for patients undergoing mechanical ventilation in the intervention group, according to Bern's checklist criteria.The researcher will evaluate the patients on a daily basis according to the checklist, and will complete the checklist for the intervention group, and will assess the readiness of the patient's weaning.If the optimal score (17 and above) is obtained, the process of weaning begins.In the absence of a desirable score, nursing interventions will focus more on the main problem that is identified in Bern during the day. Intervention 2: Control group: In the control group according to routine medical and weaning of patients with the use of certain criteria and will be done experimentally. The routine weaning method is such that the patient is alert, has a good cough and swallowing reflex, has no respiratory ventilation, and respiratory rate is not more than 35.</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:
Information on age, sex, history of underlying illness, history of smoking and drug use, and duration of admission

When:
6 months after the publication of results

To whom:
Researchers of academic and academic institutions

Conditions:
Use results

Where to obtain:
maryamsepahyar@yahoo.com
0098 61 9166003501

How to obtain:
One to two weeks after the call

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Sepahyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.104, Rezvan2 Ave, Payam Town</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6138815339</zip>
        <telephone>+98 61 3443 0804</telephone>
        <email>sepahyar.m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Sepahyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.104, Rezvan2 Ave, Payam Town</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6138815339</zip>
        <telephone>+98 61 3443 0804</telephone>
        <email>sepahyar.m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18-65 Years
Failure to develop Neuromuscular diseases
Do not receive Neuromuscular blockers</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Brain death Patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S06.3</hc_code>
      <hc_code>S06.4</hc_code>
      <hc_code>S06.5</hc_code>
      <hc_code>S06.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Focal traumatic brain injury</hc_keyword>
      <hc_keyword>Epidural hemorrhage</hc_keyword>
      <hc_keyword>Traumatic subdural hemorrhage</hc_keyword>
      <hc_keyword>Traumatic subarachnoid hemorrhage</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>Nurses will plan and conduct nursing care for patients undergoing mechanical ventilation in the intervention group, according to Bern's checklist criteria.The researcher will evaluate the patients on a daily basis according to the checklist, and will complete the checklist for the intervention group, and will assess the readiness of the patient's weaning.If the optimal score (17 and above) is obtained, the process of weaning begins.In the absence of a desirable score, nursing interventions will focus more on the main problem that is identified in Bern during the day.</i_keyword>
      <i_keyword>Control group: In the control group according to routine medical and weaning of patients with the use of certain criteria and will be done experimentally. The routine weaning method is such that the patient is alert, has a good cough and swallowing reflex, has no respiratory ventilation, and respiratory rate is not more than 35.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Successful and unsuccessful weaning. Timepoint: From weaning to 48 hours after it. Method of measurement: Registration in vital-laboratory variables questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of mechanical ventilation connection. Timepoint: The number of days a patient connected to a ventilator. Method of measurement: Record in vital-laboratory questionnaire.</sec_outcome>
      <sec_outcome>Length of admission to the intensive care unit. Timepoint: From the time of admission to the intensive care unit until the discharge from this department. Method of measurement: Demographic information questionnaire.</sec_outcome>
      <sec_outcome>The number of re-intubation. Timepoint: From the beginning of the patient's connection to the ventilator until the patient's discharge from the department. Method of measurement: Vital Laboratory Information Questionnaire.</sec_outcome>
      <sec_outcome>The RSBI index is the day before and after the weaning. Timepoint: The day before weaning and at the time of weaning. Method of measurement: Vital Laboratory Information Questionnaire.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-10</approval_date>
        <contact_name>The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>No. 104, Rezvan2 Ave, Payam Town Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
