<?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>IRCT20230623058561N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-07</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>New combined method for Ng insertion in Unconscious Intubated Patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficiency of The Combined Method of Nasogastric Tube Insertion with The Conventional Method in Unconscious Intubated Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73410</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1. Selection of a foreigner
2. Using the table of random numbers according to the sample size
3. Odd numbers are assigned to the control group and even numbers are assigned to the intervention group, Blinding description: People participating in the research and under the study are blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>NG tube insertion in intubated and unconsciousness patients.</hc_freetext>
      <i_freetext>Intervention 1: 1. In the combined method, first, the tube that is kept at 4 degrees is filled with cold normal saline (4 degrees) with the help of a gavage syringe, and the tube is clamped to prevent the saline from escaping and to prevent the tube from heating up over time the  NG tube will be place in a duration of less than 60secounds after exiting the refrigerator and the temperature of tube will be measured before placement .2. The tube enters the nostril at 90 degrees and in the hyperextension position from the side opposite to the entrance of the tracheal tube in the pharynx, so that if the tracheal tube is in the left part of the pharynx, it is entered through the right nostril.3. After the beginning of the tube reaches the nasopharynx, the patient's head changes to flexion and is turned to the opposite side of the tracheal tube relative to the position of the lips, so that if the tube is fixed in the corner of the left lip, the neck is turned towards turns right 4. In the mentioned position, nasogastric intubation continues until the marked amount reaches the patient's stomach. The amount of tube placement is calculated by the zen+10 method .5. The normal saline in the tube is aspirated and the correctness of intubation is controlled.6. The correctness of intubation is done by injecting 20 cc of air quickly and confirming the sound in the stomach by auscultation of the stomach. IN case of failure in the first attempt within 90 seconds, intubation is performed with the failed method. In case of failure after two attempts, intubation failure is recorded and then intubation is done with the help of usual methods or other methods by nurses or doctors. Intervention 2: In the control group, nasogastric intubation is performed in unconscious patients and intubation is performed in the conventional way (blind insertion).</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>Saeed Razghandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>plaque 3 / Abolkheir 15 Ave. 17North Motahari Blvd  . Mashad city</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9193754688</zip>
        <telephone>+98 51 4466 7647</telephone>
        <email>razghandis3@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hesam Sharifipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Plaque 3 / Abolkheir 15 Ave. 17North Motahari Blvd  . Mashad City</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9193754688</zip>
        <telephone>+98 51 4466 7647</telephone>
        <email>sharifipm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Order of physician for Ng tube insertion
age more than 18
patients  must be intubated
patient must be unconsciousness and not cooperating ( GCS&lt;9 or Ras &lt; -2 or   ACVPU = U )
Dose not have current bleeding
Dose not have any fractures in base skull
Dose not have esophageal varices
Not having recent surgeries in esophageal area</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unstable hemodynamics when patient need resuscitation
Narrowing or deviation of nostrils ( The NG tube dose not go forward in esophagus by nostrils )
Bradycardia ( HR &lt;60)</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1. In the combined method, first, the tube that is kept at 4 degrees is filled with cold normal saline (4 degrees) with the help of a gavage syringe, and the tube is clamped to prevent the saline from escaping and to prevent the tube from heating up over time the  NG tube will be place in a duration of less than 60secounds after exiting the refrigerator and the temperature of tube will be measured before placement .2. The tube enters the nostril at 90 degrees and in the hyperextension position from the side opposite to the entrance of the tracheal tube in the pharynx, so that if the tracheal tube is in the left part of the pharynx, it is entered through the right nostril.3. After the beginning of the tube reaches the nasopharynx, the patient's head changes to flexion and is turned to the opposite side of the tracheal tube relative to the position of the lips, so that if the tube is fixed in the corner of the left lip, the neck is turned towards turns right 4. In the mentioned position, nasogastric intubation continues until the marked amount reaches the patient's stomach. The amount of tube placement is calculated by the zen+10 method .5. The normal saline in the tube is aspirated and the correctness of intubation is controlled.6. The correctness of intubation is done by injecting 20 cc of air quickly and confirming the sound in the stomach by auscultation of the stomach. IN case of failure in the first attempt within 90 seconds, intubation is performed with the failed method. In case of failure after two attempts, intubation failure is recorded and then intubation is done with the help of usual methods or other methods by nurses or doctors.</i_keyword>
      <i_keyword>In the control group, nasogastric intubation is performed in unconscious patients and intubation is performed in the conventional way (blind insertion).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison of the number of success in NG tube placement in the combined method with the conventional method. Timepoint: Immediately after NG insertion. Method of measurement: Checking the correct placement by  Injecting 20cc of Bolus air into Tube and checking the bulb sound in stomach by stethoscope.</prim_outcome>
      <prim_outcome>Comparing the number of attempts to insert the tube in the combined method with the conventional method. Timepoint: Immediately after NG insertion. Method of measurement: Correct NG tube Placement on the first or second attempt is considered a success. Each attempt is equivalent to a duration of less than 90 seconds.</prim_outcome>
      <prim_outcome>Comparison of the elapsed time for tube placement in the combined method with the conventional method. Timepoint: Immediately after NG insertion. Method of measurement: Placement time measurement with chronometer.</prim_outcome>
      <prim_outcome>Comparison of immediate complications caused by tube placement in the combined method with the conventional method. Timepoint: Immediately after NG insertion. Method of measurement: Immediate complications include bleeding due to traumatization, twisting of the tube, bradycardia during tube placement, entering the nasogastric tube into the trachea, which is measured after tube placement.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-28</approval_date>
        <contact_name>Ethics committee of Mashad University of Medical Sciences</contact_name>
        <contact_address>15 Abolkheir Ave. 17 North motahari Blvd. 3Block Mashad city Mashad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
