<?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>IRCT20080818001048N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-20</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of modified tourniquet in the success of peripheral venous catheter Placement</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of modified tourniquet in the success of peripheral venous catheter Placement in patients admitted to Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>142</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55939</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, patients will be assigned to each of the two study groups using the law of non-replacement random allocation. For this purpose, researchers will first prepare the cards by considering the total sample size to the total number of people, in which half of the cards contain the word intervention group and in the other half the word control group. These cards are placed in a lottery container without any writing on them, and then a card is randomly recorded for each patient without being removed from the container and a sequence is created. This will be repeated until the end of sampling.
Accordingly, according to the sample size, 142 cards will be prepared, in which half of the cards will have the word intervention group and in the other half the word control group (71 cards in each group), then the cards will be placed in sealed envelopes and in the container. Draw. Then, for each patient, a card is removed from the container without replacement and the created sequence is recorded. This will be repeated until the end of sampling.
The hiding method will be done through sealed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>people recourse to medical centers for examination or treatment of the disease..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, a modified tourniquet will be used to access patients' veins. This tool is similar to a sphygmomanometer with a width of 5 cm and a length of 50 cm.The subjects will be lying on their backs and in complete relaxation. Access to the peripheral vein of the antecubital region will be in the right hand. Patients' blood pressure will be measured and recorded before the procedure. The modified instrument is closed around the patient's arm (5-10 cm above the antecubital area), the cuff pressure will be adjusted so that it is higher than the patient's diastolic pressure and less than the systolic pressure (mean systolic and diastolic pressure of the patient). The nursing specialist will hold the patient's hand in that position for a maximum of one minute, in which the protrusion and palpability will also record the vein being visible. After selecting the location, the appropriate catheter (preferably catheter 20) into the site. The access result is also recorded on the first attempt and the time spent for successful access to the vein. Catheter placement in both groups of patients is performed by a trained and trained nurse in finding vein and has 5 years of clinical experience with a suitable catheter by sterile method. Intervention 2: Control group: In the control group, a normal tourniquet will be used to check access to the vein. The subjects will be lying on their backs in complete relaxation. The preferred place of access will be the peripheral vein of the antecubital area of ​​the right hand. And the patient will be asked to punch his hand. The nursing specialist will hold the patient's hand in that position for a maximum of one minute, in which the protrusion and palpability will also record the vein being visible. After selecting the location, the appropriate catheter (preferably catheter 20) into the site. The access result is also recorded on the first attempt and the time spent for successful access to the vein. Catheter placement in both groups of patients is performed by a trained and trained nurse in finding vein and has 5 years of clinical experience with a suitable catheter by sterile method.</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 the data of this research can be share after coding the identity information of individuals and  non-identifiable the participants in the study in the form of an Excel file entitled "Research Data Sheet Code" along with the guide codes of the variables.

When:
The begins of the data access period of this research will be immediately after the publication of the results in a scientific journal.

To whom:
All qualified university researchers will be allow to access the data of this research by submitting a request.

Conditions:
The use of the data of this research for the purpose of secondary analysis of the data will be allowed by observing the principles of intellectual property and the explicit and clear request of the applicant regarding the use of the data.

Where to obtain:
Dr. Rasoul Tabari (moderator of project) / Address: Faculty of Nursing and Midwifery, Daneshjo St, shahid Beheshti highway, Rasht, Guilan. Postal code: 41469-39841 
Email: rtabari@gums.ac.ir
Tandis sayyad ghobadi / Address: Shahid Beheshti Hospital Bandar-e Anzali, km 5 Astara Road, Bandar-e Anzali, Guilan. Postal code: 43198-93151
Email: www.tandisghobadi@gmail.com

How to obtain:
The applicant for the data must first send a request in which have a clearly stated application (how to use the data and a commitment to adhere to the ethical principles and intellectual property of using the data in accordance with ICMJE guidelines) with any identification or introduction that indicates his/her scientific competence to access the data to the executor or main partner of the project. Upon receipt of the application, the applicant will be contacted by email within a maximum of two working days, and if the identity and scientific competence of the applicant is confirmed (which can be verified by checking his/her IDs in international scientific networks such as ORCiD, Scopus ), The data will be sent to him/her in the form of an Excel file and via email on the same day.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rasoul Tabari Khomeiran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery., Daneshjo St., shahid Beheshti highway.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 5001</telephone>
        <email>rtabari@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasoul Tabari Khomeiran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery., Daneshjo St., shahid Beheshti highway.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 5001</telephone>
        <email>rtabari@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No life threatening condition
Need to establish an intravenous route
Having the consent to participate in the study
Age between 18 to 65 years
No pregnancy
alertness</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having skin or vascular disorders
Having bleeding disorders
Suffering acute pain in any organ of the body during sampling</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for general examination without complaint, suspected or reported diagnosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, a modified tourniquet will be used to access patients' veins. This tool is similar to a sphygmomanometer with a width of 5 cm and a length of 50 cm.The subjects will be lying on their backs and in complete relaxation. Access to the peripheral vein of the antecubital region will be in the right hand. Patients' blood pressure will be measured and recorded before the procedure. The modified instrument is closed around the patient's arm (5-10 cm above the antecubital area), the cuff pressure will be adjusted so that it is higher than the patient's diastolic pressure and less than the systolic pressure (mean systolic and diastolic pressure of the patient). The nursing specialist will hold the patient's hand in that position for a maximum of one minute, in which the protrusion and palpability will also record the vein being visible. After selecting the location, the appropriate catheter (preferably catheter 20) into the site. The access result is also recorded on the first attempt and the time spent for successful access to the vein. Catheter placement in both groups of patients is performed by a trained and trained nurse in finding vein and has 5 years of clinical experience with a suitable catheter by sterile method.</i_keyword>
      <i_keyword>Control group: In the control group, a normal tourniquet will be used to check access to the vein. The subjects will be lying on their backs in complete relaxation. The preferred place of access will be the peripheral vein of the antecubital area of ​​the right hand. And the patient will be asked to punch his hand. The nursing specialist will hold the patient's hand in that position for a maximum of one minute, in which the protrusion and palpability will also record the vein being visible. After selecting the location, the appropriate catheter (preferably catheter 20) into the site. The access result is also recorded on the first attempt and the time spent for successful access to the vein. Catheter placement in both groups of patients is performed by a trained and trained nurse in finding vein and has 5 years of clinical experience with a suitable catheter by sterile method.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The success of peripheral venous catheter Placement. Timepoint: Maximum One minute after the start of the intervention. Method of measurement: Stopwatch, View the vein.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The time taken to successfully access the peripheral vein. Timepoint: Maximum One minute after the start of the intervention. Method of measurement: Stopwatch.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-21</approval_date>
        <contact_name>Ethics Commitee of Guilan University Of Medical Science</contact_name>
        <contact_address>Deputy of Research and Technology of Guilan University of Medical Sciences., In front of 17Sharivar Hospital., Shahid Siadati St., Namjoo Blvd. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
