<?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>IRCT20141222020394N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-04</date_registration>
      <primary_sponsor>Esfarayen University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of  continuous versus pulsative flushing on the phlebitis incidence, patency and longevity of peripheral intra venous catheter</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of  continuous versus pulsative flushing on the phlebitis incidence , patency and longevity of peripheral intra venous catheter in patients admitted to medical and surgical ward of Eesfarayen Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18088</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research, Randomization description: PASS software, Blinding description: This study will be a single blind. After giving explanations to the patients about the method of study completely and consent of patients, they fall into one of the three groups of continuous flushing, pulsative flushing and control group that they are not informe about type of group. Next,assigned  to the patient a code. numbers: one, four , Seven, ... belong to continuous Flushing , numbers: two, five, eight, ...  belong to Flushing group and numbers: three, six, nine, and ... belong to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>This study was performed on patients admitted to medical and surgical department of Eesfarayen Hospital.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: patients admitted to medical and surgical ward; interventions includ: pulsative flushing in  time of drug administration, and then check the phlebitis incidence, patency and longevity of peripheral intra venous catheter every 12 hour. Intervention 2: Intervention group2: patients admitted to medical and surgical ward; interventions includ: continuous flushing in  time of drug administration, and then check the phlebitis incidence, patency and longevity of peripheral intra venous catheter every 12 hou. Intervention 3: Control group: Patient drugs are injected according to pre determinated time , and every 12 hours to 96 hours, the catheter is controlled by phlebitis and patency.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahbobeh firooz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical Sciences Esfarāyen,Esfarāyen,North Khorasan</address>
        <city>Esfarāyen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661777944</zip>
        <telephone>+98 58 3723 2650</telephone>
        <email>mahbobehfirooz@yahoo.com</email>
        <affiliation>Faculty of Medical Sciences Esfarāyen</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahbobeh firooz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical Sciences Esfarāyen,Esfarāyen,North Khorasan</address>
        <city>Esfarāyen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>961777944</zip>
        <telephone>+98 58 3723 2650</telephone>
        <email>mahbobehfirooz@yahoo.com</email>
        <affiliation>Faculty of Medical Sciences Esfarāyen</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 65 years old
at least 96 hours are hospitalized</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: patients admitted to medical and surgical ward; interventions includ: pulsative flushing in  time of drug administration, and then check the phlebitis incidence, patency and longevity of peripheral intra venous catheter every 12 hour</i_keyword>
      <i_keyword>Intervention group2: patients admitted to medical and surgical ward; interventions includ: continuous flushing in  time of drug administration, and then check the phlebitis incidence, patency and longevity of peripheral intra venous catheter every 12 hou</i_keyword>
      <i_keyword>Control group: Patient drugs are injected according to pre determinated time , and every 12 hours to 96 hours, the catheter is controlled by phlebitis and patency.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Phlebitis incidence. Timepoint: Every 12 hours to 4 days. Method of measurement: Visual Infusion Phelebit Scale.</prim_outcome>
      <prim_outcome>Catheter patency. Timepoint: Every 12 hours to 4 days. Method of measurement: lack of resistant against injection from peripheral intra venous catheter.</prim_outcome>
      <prim_outcome>Longevity of peripheral intra venous catheter. Timepoint: Every 12 hours to 4 days. Method of measurement: Maximum catheter longevity in situ is 96 hours.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Phelebitis of peripheral intra venous catheter. Timepoint: Every 12 hours For 4 days. Method of measurement: Visual Infusion Phelebit Scale.</sec_outcome>
      <sec_outcome>Catheter patency. Timepoint: Every 12 hours For 4 days. Method of measurement: lack of resistance against of injection.</sec_outcome>
      <sec_outcome>Catheter longevity. Timepoint: Every 12 hours For 4 days. Method of measurement: catheter remain in situ for maximum for 96 hours.</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>Esfarayen University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-04</approval_date>
        <contact_name>Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Sabzevar University of Medical Sciences, Blvd Tohid Shahr,sabzevar town Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
