<?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>IRCT20220310054240N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-06</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of using forced-air warming system, warm intravenous serum with normal blanket on chills and waking time in the elderly undergoing open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of hot forced-air system and warm intravenous serum with routine (blanket) method on hemodynamic parameters, shivering and waking time in the elderly undergoing open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62460</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients in three groups will be simple randomly. One of the colleagues who will not participate in the measurement of patients' clinical indicators, determine random allocation of the patients to one of three intervention groups (Group 1: forced-air warming system Group II : Warm intravenous serum) or control (group 3: use a regular blanket) by throwing coins, Blinding description: Due to the research conditions, it is not possible to perform complete blinding. The study is single blind (patients are not aware of being in the intervention or control group). Because patients are not awake when they enter the intensive care unit, it is not possible for them to be aware of being in the control or intervention group. Patients wake up at least three hours after entering the ward, which coincides with the end of the intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>open heart surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Warm compressed air heating system with Warm Touch brand (medical equipment) with temperature between 42-38 ° C through NELLCOR WARM TOUCH 501-5900 (2011) will be used for patients undergoing open heart surgery when entering the ICU,for 4-5 hours. Intervention 2: Intervention group 2: warm intravenous serum, one liter per hour with physiological temperature at 40-37 ° C. Intervention 3: Control group: Ordinary blanket produced by a special brand in two layers with dimensions (114 by 175 cm) that covers from the armpits to the toes.</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 The type of study is a clinical trial and the information must be ethically confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Bagher Akbarpour Roushan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences; Ganj Afrooz Street</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47745-47176</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>akbarpour.mb9560@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Fotokian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences; Ganj Afrooz Street</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47745-47176</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>zfotoukian@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All elderly patients (over 60 years old) are candidates for open heart surgery at Ayatollah Rouhani Hospital in Babol
Having an esophageal temperature of less than 36 ° C
Cardiac output (EF) greater than 40%</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>multidrug addiction
Preoperative renal and hepatic insufficiency
sensory-motor disorders such as Guillain-Barré syndrome or myasthenia gravis
Receiving high-dose inotropic drugs (epinephrine, norepinephrine), antiarrhythmics (lidocaine) before the patient enters the ward
Ascending aortic dissection surgery, Bental surgery</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>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Warm compressed air heating system with Warm Touch brand (medical equipment) with temperature between 42-38 ° C through NELLCOR WARM TOUCH 501-5900 (2011) will be used for patients undergoing open heart surgery when entering the ICU,for 4-5 hours.</i_keyword>
      <i_keyword>Intervention group 2: warm intravenous serum, one liter per hour with physiological temperature at 40-37 ° C</i_keyword>
      <i_keyword>Control group: Ordinary blanket produced by a special brand in two layers with dimensions (114 by 175 cm) that covers from the armpits to the toes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: At the beginning of the study, up to 6 hours (on arrival, first hour, second hour, .... sixth hour) will be recorded from the time of entering the ICU until waking up. Method of measurement: Sphygmomanometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: At the beginning of the study, up to 6 hours (on arrival, first hour, second hour, .... sixth hour) will be recorded from the time of entering the ICU until waking up. Method of measurement: According to the checklist will be evaluated up to 6 hours until waking up.</prim_outcome>
      <prim_outcome>Respiration Rate. Timepoint: At the beginning of the study, up to 6 hours (on arrival, first hour, second hour, .... sixth hour) will be recorded from the time of entering the ICU until waking up. Method of measurement: According to the checklist will be evaluated up to 6 hours until waking up.</prim_outcome>
      <prim_outcome>Arterial Blood Gases. Timepoint: At the beginning of the study, up to 6 hours (on arrival, first hour, second hour, .... sixth hour) will be recorded from the time of entering the ICU until waking up. Method of measurement: According to the checklist will be evaluated up to 6 hours until waking up.</prim_outcome>
      <prim_outcome>Shivering. Timepoint: From the time the patient enters the ICU until he or she regains consciousness, every 15 minutes to 6 hours (on arrival, 15 minutes, 30 minutes, 45 minutes, 60 minutes ..... and 360 minutes) will be examined. Method of measurement: Crossley and Mahajan shivering benchmark evaluation methods.</prim_outcome>
      <prim_outcome>Waking time. Timepoint: From the time the patient enters the ICU until he or she regains consciousness, every 15 minutes to 6 hours (on arrival, 15 minutes, 30 minutes, 45 minutes, 60 minutes ..... and 360 minutes) will be examined. Method of measurement: RAMSAY SEDATION SCORE (RSS) Assessment Method (Awakening Assessment).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea. Timepoint: Upon arrival of the patient in the ICU until waking up every hour for 6 hours (on arrival, first hour, second hour .... and sixth hour). Method of measurement: Based on checklist.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: Upon arrival of the patient in the ICU until waking up every hour for 6 hours (on arrival, first hour, second hour .... and sixth hour). Method of measurement: Based on checklist.</sec_outcome>
      <sec_outcome>Dispenea. Timepoint: Upon arrival of the patient in the ICU until waking up every hour for 6 hours (on arrival, first hour, second hour .... and sixth hour). Method of measurement: Based on checklist.</sec_outcome>
      <sec_outcome>Arrhythmias. Timepoint: Upon arrival of the patient in the ICU until waking up every hour for 6 hours (on arrival, first hour, second hour .... and sixth hour). Method of measurement: Based on checklist.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-06</approval_date>
        <contact_name>Health Research Institute - Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences; Ganj Afrooz Street Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
