<?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>IRCT2016042527597N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-04</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Prevention of Postoprative Shivering</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Postoprative  Electrical Warming Cover and Warmed IV Fluids on Tempreture, Shivering and Physiological Indexes in Patient Undergoing General Anesthesia  at Post Anesthesia Care Unit(PACU) in Chosen Hospital Affiliated with Social Affair Organization  of Tabriz in1395</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22574</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>postanesthesia shivering.</hc_freetext>
      <i_freetext>Intervention 1: In the experimental group involving electric blankets after surgery, Beurer HD90 blankets (made in Germany) will be used. The blankets come in 130cmx180cm dimensions and could be adjusted for six different temperatures. They feature automatic shutdown system, overheating protection and performance display light. Additionally, these blankets are certified by European Oeko-Tex which approves the textile safety for the consumers. In this group, the blanket will be used after surgery such that it will be prepared and switched on fifteen minutes prior to admission of the patient into the post anesthetic care unit. Upon arrival of the patients into the recovery unit, the blankets will be laid over them and left until the patients are discharged from the recovery unit. Intervention 2: In the second experimental group in which warm intravenous fluid is used during surgery, the required liquid intake of the patient will be determined. Once the patient is transferred on to the operating table, the required liquid will be heated to 37 °C under supervision of an anesthesiologist using Biggler Warmer – BW585 assembled in Iran. To connect the intravenous fluid to the warmer set an extension tube is used having the same length for all patients. Intervention 3: In the control group, patients will receive routine care. In the studied hospital, patients receive intravenous fluid in ambient temperature during surgery and upon completion of the operation, a usual blanket is laid over patients before transferring them into the recovery room.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehryar Yoldashkhan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Nursing &amp; Midwifery Faculty, Niyayesh Intersection, Vali Asr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>yoldashkhan@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehryar Yoldashkhan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Nursing &amp; Midwifery Faculti, Niyayesh Intersection, Vali Asr Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>yoldashkhan@gmail.com</email>
        <affiliation>Sahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Following criteria will be met for the studied patients: Patients aged between 18 and 60 years; Patients who are candidates for general surgery via anesthesia; Patients without restriction on liquid intake, e.g. excluding patients with acute renal or heart failure; Patients who do not suffer from middle ear infection or from perforation of the eardrum; Patients whose physical status falls in Class 1 or 2, according to the classification of the American Society of Anesthesiologists (ASA).&#13;
Exclusion Criteria: Patients with core hypothermia or hyperthermia upon intervention; Patients who need blood transfusion during operation; Patients with duration of surgery longer than three hours; Patients who are not extubated or are not transferred to the recovery room post operation at the discretion of the anesthesiologist; Patients who receive vasoconstrictor drugs during surgery; Patient who receive Succinil Colin for induction of anesthesia.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I98</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of circulatory system in diseases classified elsewhere,</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>In the experimental group involving electric blankets after surgery, Beurer HD90 blankets (made in Germany) will be used. The blankets come in 130cmx180cm dimensions and could be adjusted for six different temperatures. They feature automatic shutdown system, overheating protection and performance display light. Additionally, these blankets are certified by European Oeko-Tex which approves the textile safety for the consumers. In this group, the blanket will be used after surgery such that it will be prepared and switched on fifteen minutes prior to admission of the patient into the post anesthetic care unit. Upon arrival of the patients into the recovery unit, the blankets will be laid over them and left until the patients are discharged from the recovery unit.</i_keyword>
      <i_keyword>In the second experimental group in which warm intravenous fluid is used during surgery, the required liquid intake of the patient will be determined. Once the patient is transferred on to the operating table, the required liquid will be heated to 37 °C under supervision of an anesthesiologist using Biggler Warmer – BW585 assembled in Iran. To connect the intravenous fluid to the warmer set an extension tube is used having the same length for all patients.</i_keyword>
      <i_keyword>In the control group, patients will receive routine care. In the studied hospital, patients receive intravenous fluid in ambient temperature during surgery and upon completion of the operation, a usual blanket is laid over patients before transferring them into the recovery room.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Peripheral body tempreture. Timepoint: upon admission of the patient into the operating room, before induction of anesthesia, immediately following the induction and then every 15 minutes until patient is discharged from the recovery unit. Method of measurement: by digital thermometer EmsiG- CT20 made in Germany.</prim_outcome>
      <prim_outcome>Core body tempreture. Timepoint: upon admission of the patient into the operating room, before induction of anesthesia, immediately following the induction and then every 15 minutes until patient is discharged from the recovery unit. Method of measurement: by digital infrared thermometer, EmsiG - CT30  made in Germany to measure the tympanic membrane temperature.</prim_outcome>
      <prim_outcome>Physiologic indices. Timepoint: upon admission of the patient into the operating room, before induction of anesthesia, immediately following the induction and then every 15 minutes until patient is discharged from the recovery unit. Method of measurement: measured by Saadat vital signs monitors, Model Alborz-B produced by Pooyandegan Rah Saadat Company of Iran.</prim_outcome>
      <prim_outcome>Post oprative shivering. Timepoint: every 15 minutes at post anesthesia care unit. Method of measurement: the scale described by Crossley and Mahajanto.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>nursing &amp; midwifery faculty of shahid beheshti university of medical science</contact_name>
        <contact_address>shahid beheshti nursing &amp; midwifery faculty-niyayesh intersection- vally asr street-tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
