<?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>IRCT20191218045773N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-22</date_registration>
      <primary_sponsor>Esfarayen University of Medical Sciences</primary_sponsor>
      <public_title>Effect of local warming and vein viewer on success rate for inserting of peripheral venous catheter in pediatrics</public_title>
      <acronym></acronym>
      <scientific_title>Comparing of local warming and intravenous assistive device (vein viewer) on duration and first attempt success rate for inserting of peripheral venous catheter in 1- 36 months pediatrics referred to pediatric ward of imam Khomeini hospital in esfarayen, iran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44325</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Samples are randomly assigned to four groups using a random number table. Numbers 00-24 for local warming intervention, 25-49 numbers for vein viewer intervention, 50-74 numbers for local warming with vein viewer group device and numbers 75-99 are considered for the control group. The researchers then put on one of the numbers on the table of random numbers and move to the right and down of the table. We record the numbers and assign them to different groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Diarrhea. Condition 2: Pneumonia. Condition 3: Urinary tract infection.</hc_freetext>
      <i_freetext>Intervention 1: Vein viewer device group: After fasten the tourniquet on the upper limbs (hands), nurse turn on vein viewer device (Vein light LED plus)  and illuminate at 90 degrees in skin. After observing the vein, 70% alcohol is rubbed site, then the peripheral catheter N.24 will be inserted. Intervention 2: In the intervention local warming group , Nurse fasten the tourniquet and determine a suitable vein. then, she open tourniquet and put on"hot-water bottle" (40 ° C )  that wrapped in a texture( temperature will be confirmed by laser thermometer) in site of catheter insertion. it remain on the skin for 2 min. skin temperature is checked every 30 seconds. Again, the tourniquet is fastened in the upper limb and peripheral catheter will be inserted at a predetermined site. Intervention 3: Combination Intervention group (local warming plus vein viewer device) : Nurse fasten the tourniquet and determine a suitable vein. Then, she open tourniquet and put on "hot-water bottle" (40 ° C ) in site of catheter insertion that wrapped in a texture( temperature will be confirmed by laser thermometer). It remain on the skin for 2 min. skin temperature is checked every 30 seconds. Again, the tourniquet is fastened in the upper limb, nurse turn on vein viewer device (Vein light LED plus)  and illuminate at 90 degrees on skin. After observing the vein, 70% alcohol is rubbed site, then the peripheral catheter N.24 will be inserted. Intervention 4: In control group, nurse fasten tourniquet and  based on their previous experience insert the catheter after disinfection site with Alcohol 70%.</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:
Documentation is registered "Pajouhan" system after completion of the study . Also,  participants general information and the effectiveness of interventions will be recorded in the article.

When:
Accessibility after publish of article

To whom:
People interested in pediatric nursing scope

Conditions:
People looking for ways to facilitate catheter insertion in pediatric who can access the data

Where to obtain:
Faculty of Medical Sciences Esfarāyen, imama reza s.tEsfarāyen,North Khorasan

How to obtain:
They can access to data through below email as soon as possible
s.j.hoseini2016@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Javad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Esfarāyen Faculty of Medical Sciences , Imama Reza S.t, Esfarāyen, North Khorasan</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76981-96618</zip>
        <telephone>0098 5831550000- 602</telephone>
        <email>s.j.hoseini2016@gmail.com</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Javad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Esfarāyen Faculty of Medical Sciences , Imam Reza S.t, Esfarāyen, North Khorasan</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76981-96618</zip>
        <telephone>+98 58 3723 2650</telephone>
        <email>s.j.hoseini2016@gmail.com</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age less than 36 months and more than one month.
Patients require to the insert of catheter</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>36 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parental unwillingness to cooperate
Patient has a emergency condition.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R19.7</hc_code>
      <hc_code>A37.91</hc_code>
      <hc_code>N39.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diarrhea, unspecified</hc_keyword>
      <hc_keyword>Whooping cough, unspecified species with pneumonia</hc_keyword>
      <hc_keyword>Urinary tract infection, site not specified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Vein viewer device group: After fasten the tourniquet on the upper limbs (hands), nurse turn on vein viewer device (Vein light LED plus)  and illuminate at 90 degrees in skin. After observing the vein, 70% alcohol is rubbed site, then the peripheral catheter N.24 will be inserted.</i_keyword>
      <i_keyword>In the intervention local warming group , Nurse fasten the tourniquet and determine a suitable vein. then, she open tourniquet and put on"hot-water bottle" (40 ° C )  that wrapped in a texture( temperature will be confirmed by laser thermometer) in site of catheter insertion. it remain on the skin for 2 min. skin temperature is checked every 30 seconds. Again, the tourniquet is fastened in the upper limb and peripheral catheter will be inserted at a predetermined site.</i_keyword>
      <i_keyword>Combination Intervention group (local warming plus vein viewer device) : Nurse fasten the tourniquet and determine a suitable vein. Then, she open tourniquet and put on "hot-water bottle" (40 ° C ) in site of catheter insertion that wrapped in a texture( temperature will be confirmed by laser thermometer). It remain on the skin for 2 min. skin temperature is checked every 30 seconds. Again, the tourniquet is fastened in the upper limb, nurse turn on vein viewer device (Vein light LED plus)  and illuminate at 90 degrees on skin. After observing the vein, 70% alcohol is rubbed site, then the peripheral catheter N.24 will be inserted.</i_keyword>
      <i_keyword>In control group, nurse fasten tourniquet and  based on their previous experience insert the catheter after disinfection site with Alcohol 70%.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>First attempt success rate for inserting of peripheral venous catheter. Timepoint: Immediately after fixation of catheter on the skin. Method of measurement: Possible to injection of "water for injection" from the Y-shaped part of the "Micro Drop Infusion Set" without causing swelling at the top of catheter insertion.</prim_outcome>
      <prim_outcome>Inserting of peripheral venous catheter duration. Timepoint: Since initiation catheter insertion until it is fixed in place. Method of measurement: Using the Stopwatch.</prim_outcome>
      <prim_outcome>The time spent to find a peripheral venous. Timepoint: Since the fasten of tourniquet to start inserting of peripheral venous catheter. Method of measurement: Using the Stopwatch.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>2019-12-09</approval_date>
        <contact_name>Ethics committee of Esfarayen faculity of Medical Sciences</contact_name>
        <contact_address>Faculity of Medical Sciences, Imam Reza S.t, Esfarayen, North Khorasan Esfarayen North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
