<?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>IRCT20190614043888N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-08</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study of complications during and after intubation in patients undergoing surgery by direct and video laryngoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of complications during and after intubation in patients undergoing surgery by direct and video laryngoscopy in Fatemi hospital in 1397 and 1398</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>132</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40263</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, people will be divided into two groups by random number table. According to this table, people in the couple's home will fall into the videolaryngoscope group and those in the individual home will be in the laryngoscopic group, Blinding description: Patients entered the study after obtaining satisfaction without the methodological knowledge of Intubation, divided into two groups of Classic Intubation and Video Laryngoscope Intubation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>In the study of Lyon et al., A randomized study between two groups of Direct laryngoscope and Video laryngoscope in emergent patients was done.Two groups of trained students, one group of Video laryngoscope and the others of Direct laryngoscope used.85 patients who needed emergency intubation were included in the study. Finally, in terms of the duration of intubation, the mean intake in Direct laryngoscopy who had the mean time 25.9 second and the other group was 30.4 second. Regarding the shorter time in Direct layngoscopy, but no statistically significant difference.(P value&gt;0.05) Regarding the success rate of intubation in the above two methods, the success rate of intubation was in the Video laryngoscope 94.7% and in the Direct laryngoscope 86.1% but that was not statistically significant..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients who need surgery under video Laryngoscopy are intubated. Laryngoscope for first year anesthesia assistants Theorical and practical classes in the classroom and training on mannequins in skill lab. After the training is over, Students are divided into two groups randomly assigned to Video laryngoscope intubation by general anesthesia under the supervision of their assistant. Intervention 2: Control group:  Patients who need surgery under Direct Laryngoscopy are intubated.  After the training is over, Students are divided into two groups randomly assigned to Direct laryngoscope intubation by general anesthesia under the supervision of their assistant.</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 how the study is performed and the results of the study are shared

When:
Start of access period 12 months after the results are published

To whom:
All students and researchers working in academic institutes and universuties

Conditions:
Using of the method and results of the study

Where to obtain:
Student Research Committee of Ardabil University of Medical Sciences

How to obtain:
With a visit of Ardabil University of Medical Science, Refer to the Student Research Committee, then the student research projects registration system is accessible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pedram Golestaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No20, Omid Alley., Valli St.</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>56196-43941</zip>
        <telephone>+98 913 027 2048</telephone>
        <email>g.golestaneh@arums.ac.ir</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Mohammadian Ardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemi hospital, Shariati Ave.</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>56147-33775</zip>
        <telephone>+98 45 3326 1600</telephone>
        <email>mohammadian.a.e@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient with condition of General Anesthesia by Intubation
Patient satisfaction for participate in the study
The patient ASA is 1 and 2
Candidate for Elective Surgery
Age of patients between 18 till 70 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Change in Intubation for example Rapid Sequence Intubation
Emergent patient
Anatomical disorders of mouth or tounge or face
The patient has a Cardio pulmonary disease
The patient has a Cold</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients who need surgery under video Laryngoscopy are intubated. Laryngoscope for first year anesthesia assistants Theorical and practical classes in the classroom and training on mannequins in skill lab. After the training is over, Students are divided into two groups randomly assigned to Video laryngoscope intubation by general anesthesia under the supervision of their assistant.</i_keyword>
      <i_keyword>Control group:  Patients who need surgery under Direct Laryngoscopy are intubated.  After the training is over, Students are divided into two groups randomly assigned to Direct laryngoscope intubation by general anesthesia under the supervision of their assistant.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of Intubation and its success rate. Timepoint: Intra intubation. Method of measurement: Stopwatch, Seeing.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemodynamic status. Timepoint: Intra Intubation and 4 and 12 hours after operation. Method of measurement: Barometer, 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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-05</approval_date>
        <contact_name>Research Ethics Committee of  Ardabil University of Medical Sciences</contact_name>
        <contact_address>Daneshghah Ave, Ardabil University of Medical Sciences Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
