<?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>IRCT20110103005536N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-01</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of patient extubation after septoplasty operation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of patient extubation in sitting versus supine position after septoplasty operation in 501 AJA hospital.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33306</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients were randomly assigned to the Simple Random Sampling method using black and white cards (each group was 30), so that patients with a black card to group one, and patients with a white card The second group is dedicated and this process is repeated again, Blinding description: - Patients undergoing anesthesia awake without knowing where they are being exposed.
  2. The person collecting the information that is entered into the room after extubation of the patient and does not know how to extubate the patient.
3. The person analyzing the information that is not present in the operating room and only has access to the encoded information and is not aware of how each patient is extubating.</study_design>
      <phase>N/A</phase>
      <hc_freetext>septoplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients using the Simple Random Sampling sampling method are divided into two groups using black and white cards (30 people per group). In one group, after the operation and the return of force to the patient's muscles and their muscle relaxation, we perform extubation of the tracheal tube in "supine" position, and cases of decreased arterial oxygen saturation, need for frequent suctions, cases of laryngospasm, cases of restlessness in recovery, increased pressure. We record blood and heart rate in patients. Intervention 2: Intervention group: Patients using the Simple Random Sampling sampling method are divided into two groups using black and white cards (30 people per group). In one group, after the operation and the return of force to the patient's muscles and their muscle relaxation, we perform extubation of the tracheal tube in "sitting" position, and cases of decreased arterial oxygen saturation, need for frequent suctions, cases of laryngospasm, cases of restlessness in recovery, increased pressure. We record blood and heart rate in patients.</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:
All data can be shared after it is unrecognizable

When:
Start the access period after printing the results

To whom:
All researchers and colleagues in this field

Conditions:
For the purpose of therapeutic-research purposes and by mentioning the names of the authors of the article

Where to obtain:
Dr. mohamadreza rafiei

How to obtain:
sending an email to Dr. mohamadreza rafiei

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mohamadreza Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Fatemi . Etemadzadeh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8158177365</zip>
        <telephone>+98 31 3261 6302</telephone>
        <email>mo_rafiei@armyums.ac.ir</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohamadreza Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Fatemi , Etemadzadeh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8158177365</zip>
        <telephone>+98 31 3261 6302</telephone>
        <email>rafiei_mohamadreza@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patient in 20-60 years old
ASA 1</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patient with ASA II, III, IV
hematologic disorders
cervical rheumatoid arthritis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Deflection or deviation of septum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients using the Simple Random Sampling sampling method are divided into two groups using black and white cards (30 people per group). In one group, after the operation and the return of force to the patient's muscles and their muscle relaxation, we perform extubation of the tracheal tube in "supine" position, and cases of decreased arterial oxygen saturation, need for frequent suctions, cases of laryngospasm, cases of restlessness in recovery, increased pressure. We record blood and heart rate in patients.</i_keyword>
      <i_keyword>Intervention group: Patients using the Simple Random Sampling sampling method are divided into two groups using black and white cards (30 people per group). In one group, after the operation and the return of force to the patient's muscles and their muscle relaxation, we perform extubation of the tracheal tube in "sitting" position, and cases of decreased arterial oxygen saturation, need for frequent suctions, cases of laryngospasm, cases of restlessness in recovery, increased pressure. We record blood and heart rate in patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Position of extubation. Timepoint: during the intervention. Method of measurement: observation. this parameter evaluates in two position: supine and sitting.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: during the intervention. Method of measurement: monitoring of patient blood pressure.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: during the intervention. Method of measurement: monitoring of patient heart rate.</sec_outcome>
      <sec_outcome>Arterial oxygen saturation. Timepoint: during the intervention. Method of measurement: monitoring of patient arterial oxygen saturation.</sec_outcome>
      <sec_outcome>Laryngospasm. Timepoint: during the intervention. Method of measurement: clinical.</sec_outcome>
      <sec_outcome>Agitation. Timepoint: during the intervention. Method of measurement: Richmond agitation sedation scale (RASS).</sec_outcome>
      <sec_outcome>Oral suction. Timepoint: during the intervention. Method of measurement: Count the number of times you need to suction with the device.</sec_outcome>
      <sec_outcome>Age. Timepoint: before start of intervention. Method of measurement: patient identification card.</sec_outcome>
      <sec_outcome>Gender. Timepoint: Before start of intervention. Method of measurement: based on the phenotype.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-06</approval_date>
        <contact_name>Ethics committee of AJA university of medical sciences</contact_name>
        <contact_address>West Fatemi- Etemadzadeh Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
