<?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>IRCT20201229049876N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-06</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the Impact of a Nutrition Management Program with Inter Professional Approach on the Success of Patients Weaning</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Impact of a Nutrition Management Program with Inter Professional Approach on the Success of Patients Weaning Under Mechanical Ventilation in the Intensive Care Unit in selected hospitals of Isfahan University of Medical Sciences in 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53378</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients who meet the inclusion criteria are entered into the study by easy sampling, then each sample is randomly selected by lot, so numbers 1 to 70 are placed in a box, and for each sample, The patient nurse is asked to select one of the numbers from the box. If the selected number is even, the sample is placed in the experimental group and if the selected number is odd, it is placed in the control group, Blinding description: The participant does not know if he or she is in the experimental or control group, and because patients have mechanical ventilation, as the level of consciousness decreases, informed consent is obtained from the legal guardian and they are told that your patient may be in the control  or experimental group .</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients under mechanical ventilation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the experimental group, a nutritional management program is implemented by an interprofessional team.This nutrition management program has a special focus on performing initial nutrition screening, complete nutritional assessment and estimating the nutritional needs of each patient, developing a diet plan based on sharing information about the nutritional status, treatment, clinical course of the disease by the patient. Interprofessional team members in joint rounds and ongoing nutrition monitoring, holding joint weekly meetings as needed to review patients' problems, case studies of patients with complex conditions, and discuss the nutrition therapy process. Intervention 2: Control group: In the control group, patients will receive a routine nutrition program in intensive care units in accordance with the protocol developed by the special wards of hospitals affiliated to Isfahan University of Medical Sciences, and their diet will be led by a physician.  And the interprofessional nutrition group will not meet the patients in the control group and the nurse will not play a role in the patient's nutritional assessment and nutrition joint decision making, the doctor, the nutritionist will each visit the patient separately.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Eghbali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib St, Azadi Square., Isfahan University of Medical Sciences, Isfahan School of Nursing and Midwifery</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673465</zip>
        <telephone>+98 31 3792 7540</telephone>
        <email>eghbali.m1363@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Eghbali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib St, Azadi Square., Isfahan University of Medical Sciences, Isfahan School of Nursing and Midwifery</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673465</zip>
        <telephone>+98 31 3792 7540</telephone>
        <email>eghbali.m1363@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtaining informed written consent from the patient's first degree relatives
- Patients under mechanical ventilation with endotracheal tube
- Patients aged 18-70 years
Do not have absolute and relative contraindications to Enteral Nutrition (EN)
Have a level of consciousness of Glasgow scale 8 and above (5 T and above)
No diseases such as - (chronic obstructive pulmonary disease and uncontrollable active respiratory infection)
Having a body mass index (BMI) less than 30 and more than18 .5</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Stay less than 72 hours in the intensive care unit
Need to continue mechanical ventilation due to brain death
The unwillingness of the patient's relatives to continue participating in the study
Tube exit program in the first 24 hours of admission</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: In the experimental group, a nutritional management program is implemented by an interprofessional team.This nutrition management program has a special focus on performing initial nutrition screening, complete nutritional assessment and estimating the nutritional needs of each patient, developing a diet plan based on sharing information about the nutritional status, treatment, clinical course of the disease by the patient. Interprofessional team members in joint rounds and ongoing nutrition monitoring, holding joint weekly meetings as needed to review patients' problems, case studies of patients with complex conditions, and discuss the nutrition therapy process.</i_keyword>
      <i_keyword>Control group: In the control group, patients will receive a routine nutrition program in intensive care units in accordance with the protocol developed by the special wards of hospitals affiliated to Isfahan University of Medical Sciences, and their diet will be led by a physician.  And the interprofessional nutrition group will not meet the patients in the control group and the nurse will not play a role in the patient's nutritional assessment and nutrition joint decision making, the doctor, the nutritionist will each visit the patient separately.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of successful weaning. Timepoint: We will evaluate the patient's readiness for weaning with a Burn scale  daily until the day of weaning or up to 15 days after the start of the study, and for patients who are ready for weaning, we will evaluate the success of weaning from the ventilator 30-120 minutes after weaning. Method of measurement: Patient readiness for weaning with: Checklist for weaning of patients from mechanical ventilation (Burn scale) and evaluation of success and failure in weaning with the evaluation checklist for spontaneous respiration intolerance criteria in weaning from ventilator is checked.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weaning readiness score with the Burn tool. Timepoint: The first day of the study until the end of the study on a daily basis. Method of measurement: Patient Isolation Questionnaire from Burn Mechanical Ventilation.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-09</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib St., Isfahan University of Medical Sciences and Health Services Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
