<?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>IRCT20171217037916N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-08</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of gastric residual volume measurement on calorie intake in patients admitted to the intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>Determining the effect of not measuring the gastric residual volume on the success rate in achieving the target calorie of enteral nutrition in patients with endotracheal tubes hospitalized in the intensive care units of Namazi Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72900</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization table will be used.After determining the sequence of random allocation, the names of the groups are placed in closed envelopes based on the agreed names of A and B respectively and based on the specified sequence. These envelopes are numbered in order. After the subjects entered the study and performed the initial assessments, a sealed envelope, based on the order placed, containing the contracted name of the participant's assigned group, which was determined based on the sequence of random assignment by a person outside the study, was opened for the individual to name Determine the contract of the assigned group. In this way, the allocation sequence is blinded for the executive team, Blinding description: In this study, in order to hide the random assignment, the names of the groups are placed in closed envelopes based on the conventional names A and B, respectively and based on the specified sequence. The participants in the study will not be aware of which group they have been assigned to until the end of the study, and the data analyst will not be aware of the assigned group and the intervention until the end of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients undergoing mechanical ventilation in the intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Not to measure gastric residual volume before each feeding of the patient for 7 days. Intervention 2: Control group:  measurement  the gastric residual volume before each feeding of the patient according to the existing protocol for 7 days.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Mousavi Shirazi Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nutrition and Food Sciences, Razi Street, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7138414336</zip>
        <telephone>+98 71 3725 1004</telephone>
        <email>z_mousavi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Mousavi Shirazi Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nutrition and Food Sciences, Razi Street, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 71 3725 1004</telephone>
        <email>z_mousavi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age equal to or older than 18 years
Patients who have enteral nutrition through a nasogastric or orogastric tube after tracheal intubation and are expected to be mechanically ventilated for more than a week</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have had gastrointestinal surgery
pregnancy
Patients with gastrostomy and jugenostomy tubes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z99.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependence on respirator</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Not to measure gastric residual volume before each feeding of the patient for 7 days</i_keyword>
      <i_keyword>Control group:  measurement  the gastric residual volume before each feeding of the patient according to the existing protocol for 7 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of reaching the target calories 48 hours after the start of enteral feeding. Timepoint: 7 days. Method of measurement: The amount of feeding  received by the patient during 24 hours will be collected by the nurse, then it will be divided by the amount of feeding ordered by the doctor, and then the percentage will be multiplied If the resulting number is equal to or more than 90% within 48 hours after the start of enteral feeding, it will be considered that the target calories have been reached.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Vomiting, diarrhea, abdominal distension, length of stay in ICU, mortality in ICU. Timepoint: 7 days. Method of measurement: Designed form.</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>Shiraz university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-11</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>6th Floor,  Administration Building of Shiraz University of Medical Sciences  Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
