<?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>IRCT20180324039145N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-02</date_registration>
      <primary_sponsor>Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine</primary_sponsor>
      <public_title>Airflow systems in the operating rooms and  the heat loss of patients during surgery.</public_title>
      <acronym>ALARIPHURS</acronym>
      <scientific_title>Are the operating rooms with laminar airflow systems a risk for inadvertent perioperative hypothermia during ureterorenoscopic lithotripsy under spinal anesthesia? A prospective randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34885</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: A total of 100 volunteers will be included in this study and divided two groups, laminar airflow systems [Group LAS (n = 50)] and conventional airflow systems [Group CAS (n = 50)].
The random number generation program of the Microsoft Office Exel program will be used to determine the groups of patients (with 100 blocks).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Inadvertent perioperative hypothermia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients who will undergo ureterorenoscopic lithotripsy under spinal anesthesia, determined according to randomization, will be taken to the operating rooms with laminar airflow (LAS-OR). Intervention 2: Control group: Patients who will undergo ureterorenoscopic lithotripsy under spinal anesthesia, determined according to randomization, will be taken to the operating rooms with conventional airflow (CAS-OR).</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 no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Recai Dagli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Bagbasi St., Kirsehir</address>
        <city>Kirsehir</city>
        <country1>Turkey</country1>
        <zip>40100</zip>
        <telephone>+90 386 213 45 15</telephone>
        <email>recai.dagli@ahievran.edu.tr</email>
        <affiliation>Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Recai Dagli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 10, Bagbasi St., Kirsehir</address>
        <city>Kirsehir</city>
        <country1>Turkey</country1>
        <zip>40100</zip>
        <telephone>+90 386 213 45 15</telephone>
        <email>recai.dagli@ahievran.edu.tr</email>
        <affiliation>Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Turkey</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patients who will be applied ureterorenoscopic surgery under spinal anesthesia
The patients who ASA (American Society of Anesthesiologists) score I-II
The patients who in the 18-65 age group
The patients who with the body mass index (BMI) between 18.5-29.9</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients who treated for hypothyroid or hyperthyroid
The patients who treated for corticoadrenal insufficiency
The patients who treated for hypertension or arrhythmia
The patients who treated for  hypothermia during preoperative period.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypothermia following anesthesia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Early detection</i_code>
      <i_code>Early detection</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients who will undergo ureterorenoscopic lithotripsy under spinal anesthesia, determined according to randomization, will be taken to the operating rooms with laminar airflow (LAS-OR).</i_keyword>
      <i_keyword>Control group: Patients who will undergo ureterorenoscopic lithotripsy under spinal anesthesia, determined according to randomization, will be taken to the operating rooms with conventional airflow (CAS-OR).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To detect the change between the preoperative temperature and the temperature measured each fifteen-minutes during the ureterorenoscopic lithotripsy  (ΔT). Timepoint: every fifteen-minutes during the ureterorenoscopic lithotripsy, until the end of the operation. Method of measurement: The tympanic membrane temperature of patients will be measured with Braun IRT6520.</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>Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-27</approval_date>
        <contact_name>Ahi Evran University Ethics Committee for Clinical Investigations</contact_name>
        <contact_address>No.100, Bagbasi St, Kirsehir Kirsehir Kirsehir Turkey</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
