<?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>IRCT20120910010800N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-12</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the radial artery catheterization success rates of first-year anesthesia residents who had or had not received ultrasonography practice.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the radial artery catheterization success rates of first-year anesthesia residents who had or had not received ultrasonography practice.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>320</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63947</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are selected for each resident by available sampling method. Patients are assigned to one of the two methods of palpation and radial artery catheterization based on the randomization sequence prepared using PASS software using the randomization method with permutation blocks with a block size of 4 with allocation (2x2). In randomization, each resident is considered as a stratum. Allocation of patients with this method will be done by an anesthesiologist who will not be involved in the next stages of the research and before the patient enters the operating room by opening the non-transparent sealed envelope containing the name of the group, Blinding description: An anesthesia technician, who will not play a role in the research, will open an opaque sealed envelope based on a random sequence generated by the software during the patient's admission to the operating room and inform the responsible anesthesiologist. The anesthesiologist will call the resident associated with the patient group to perform catheterization and record the results of the resident's work. Then, without informing the main researcher, this information will be delivered to the statistical consultant of the project to be recorded in the statistical software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Increase the success rate of radial artery catheterization.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ten residents who each experienced ultrasound-guided catheterization in 16 patients in the first phase of the study will use the palpation method of radial artery catheterization in 16 other patients. Intervention 2: Control group: Ten residents who each experienced the use of the palpation method in 16 patients in the first phase of the study will again use the palpation method for radial artery catheterization in 16 additional patients.</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:
All data is potentially shareable after unidentified individuals.

When:
One year after the publication of the article.

To whom:
All jobs

Conditions:
All non-personal patient information (anonymously) can be accessed by contacting the responsible author.

Where to obtain:
Email to: drdariushabtahi@yahoo.com

How to obtain:
Sending email and review by the responsible author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dariush Abtahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Hossein Hospital, Shahid Madani St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1617763141</zip>
        <telephone>+98 21 2263 2611</telephone>
        <email>d.abtahi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dariush Abtahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Hossein Hospital, Shahid Madani St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1617763141</zip>
        <telephone>+98 21 2263 2611</telephone>
        <email>d.abtahi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients older than 18 years
Classification of patients' physical status according to the American Society of Anesthesiologists (ASA) one and two
Need to monitor arterial blood pressure for elective surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction with participating in the study
Existence of any skin inflammation near the catheter entry site
Previous surgery near the catheter entrance
Abnormal result of the modified Allen test
History of radial artery catheterization in the past month
History of peripheral artery disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>4A133B1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Monitoring of Arterial Pressure, Peripheral, Percutaneous Approach</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ten residents who each experienced ultrasound-guided catheterization in 16 patients in the first phase of the study will use the palpation method of radial artery catheterization in 16 other patients.</i_keyword>
      <i_keyword>Control group: Ten residents who each experienced the use of the palpation method in 16 patients in the first phase of the study will again use the palpation method for radial artery catheterization in 16 additional patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success rate in the first attempt. Timepoint: The first 5 minutes of catheterization. Method of measurement: Measuring time and observing the success of anesthesia resident performance in radial artery catheterization by an anesthesiologist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Final success rate. Timepoint: During catheterization time. Method of measurement: An anesthesiologist observes the performance of the anesthesia resident.</sec_outcome>
      <sec_outcome>The time taken to complete the catheterization. Timepoint: During catheterization time. Method of measurement: Measurement with a stopwatch by an anesthesiologist.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-30</approval_date>
        <contact_name>Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me</contact_name>
        <contact_address>Emam Hossein Hospital, Shahid Madani St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
