<?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>IRCT138810142954N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-04-20</date_registration>
      <primary_sponsor>Chancellor for research of Shahroud University of Medical Sciences and Health</primary_sponsor>
      <public_title>comparison  of subclavian and jugular vein catheters  Side effects</public_title>
      <acronym></acronym>
      <scientific_title>A Clinical trial for comparison between side effects of  subclavian and jugular vein catheters  in hemodialysis patients of hemodialysis ward of Immam Hossein hospital on first half of 2011</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2837</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Evaluation of side effects of subclavian and jugullar vein cateters.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group :Subclavian cathater prepare with estandard(ACS ) method.Our needle(N.22 ) is induced 2 cm below the mid clavicular line toward the supra sternal notch.We push the needle with suction and after aspiration of venous blood, put the guide wire and the fix the cathater. Intervention 2: Control group :Jugullar cathater prepare with standard (ACS )method.We put the needle (N.22 )just at the top of the triangular of SCM muscles head that stuck to clavicale and them push it with suction and immediately after aspiration of venous blood .We put the guide wire and fix the cathater.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://knh.shmu.ac.ir/index.php/site/article/view/393</results_url_link>
      <results_summary>         Abstract:&lt;br /&gt;&#13;
Introduction: To use the large vessels of the body, the subclavian and jugular veins had the most applications and they are used in most cases. Since the advantages and disadvantages of each of these two catheterization methods are unknown, this study evaluated the effects of subclavian and jugular catheterization procedures among dialysis patients to determine the best method.&lt;br /&gt;&#13;
Methods: This study was a randomized clinical trial performed on all dialysis patients requiring venous catheter that referred to Imam Hossain hospital in the first half of the 2011 and approved participation in the project. In this study, patients were divided randomly into two groups of intervention (jugular catheter) and control (subclavian catheter), and after primary activities, in the operating room, venous catheter was placed for them by using the standard procedure. The shunt complications such as infection, heamothorax, and pneumothorax were investigated 1, 6, 12, 24 and 48 hours after surgery. In this study patients were divided into two groups,intervention group (52.9%) and control group (47.9%).&lt;br /&gt;&#13;
Results: The average incidence of infection in intervention group was 6.9 ± 5.3 and in control group was 7.3 ± 6.1, and they were not significantly different. The average incidence of heamothorax in control group 6.4 ± 4.1 was significantly higher than intervention group 4.2 ± 2.5 (P          </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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Mohammad Bagher Sohrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Education ward of Immam Hossein hospital of Shahroud, The end of street of Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3616911151</zip>
        <telephone>+98 27 3334 2000</telephone>
        <email>mb.sohrabi@shmu.ac.ir ;       mb.sohrabi@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences and Health</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohammad Reza Abdoulhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Surgery ward of Immam Hossein hospital , The end Imam street of Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3616911151</zip>
        <telephone>+98 27 3334 2000</telephone>
        <email>mra_75@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences and Helth</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :All hemodialysis patients that  need  venous catheter with out anesthesia contraindication.&#13;
Exclusion criteria :The patients with anesthesia contraindication.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of innominate or subclavian artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group :Subclavian cathater prepare with estandard(ACS ) method.Our needle(N.22 ) is induced 2 cm below the mid clavicular line toward the supra sternal notch.We push the needle with suction and after aspiration of venous blood, put the guide wire and the fix the cathater.</i_keyword>
      <i_keyword>Control group :Jugullar cathater prepare with standard (ACS )method.We put the needle (N.22 )just at the top of the triangular of SCM muscles head that stuck to clavicale and them push it with suction and immediately after aspiration of venous blood .We put the guide wire and fix the cathater.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of infection. Timepoint: First day,third days and one week , two week and three week after surgery. Method of measurement: Patient examination.</prim_outcome>
      <prim_outcome>Evaluation of hemothorax. Timepoint: First and 6 hours and after day after surgery. Method of measurement: Patient examination.</prim_outcome>
      <prim_outcome>Evaluation of  pnumothorax. Timepoint: First and 6 hours and after day after surgery. Method of measurement: Patient examination.</prim_outcome>
      <prim_outcome>Evaluation of ferequency surgery. Timepoint: Priod time of surgery. Method of measurement: Time measurement at surgery.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Permanent priod of subclavian and jugullar cataters. Timepoint: Befor intervention , 2 months, 4 months and 6 months after surgery. Method of measurement: Patient  examination.</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>Chancellor for research of Shahroud University of Medical Sciences and Health</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-05</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences and Health</contact_name>
        <contact_address>7 Tir SQ of Shahroud .Chancellor for research of Shahroud University of Medical Sciences and Health of Shahroud Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
