<?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>IRCT20210222050463N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-06</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>A guidance system in the post-anesthesia care unit</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Impact of a Scoring System and Anesthesia Guide on Early Diagnosis and Intervention in the Post Anesthesia Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54553</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: The randomization of the patients was performed during the preoperative period. The patients were requested to draw one of the two sealed envelopes; one denoting the study group and the other denoting the control group. To achieve equal distribution of the patients to the groups, Simple individual randomization was performed after the total number of patients who would undergo the operation at the same day was determined. If the total number of patients was 6 on a certain day and 3 of them drew the study group envelope, the rest of the patients were just allocated to the control group without drawing envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiopulmonary complications.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the study group receive the necessary interventions as indicated in the anesthesiologist's guide. If the score is EWSS≤4, the patient is monitored every 10 minutes. If the patient's EWSS score is 5, the patient is monitored every 5 minutes. If the patient's score does not change, monitoring is continued every 5 minutes. However, if the patient's score drops to ≤4, monitoring is performed every 10 minutes. If the score increases, the follow-up will continue for 5 minutes and the emergency team will be called to evaluate the patient. Intervention 2: Control group: All patients are scored according to EWSS during the PACU period. Patients in the control group do not receive any intervention as directed by the anesthesiologist, even if they have a high score.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is A decision will be made after the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Noushin Sarvi Sarmeidani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6143975617</zip>
        <telephone>+98 61 3390 6395</telephone>
        <email>nooshinsarvi9192@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Noushin Sarvi Sarmeidani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6143975617</zip>
        <telephone>+98 61 3390 6395</telephone>
        <email>nooshinsarvi9192@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Volunteer to participate in this research
Under general anesthesia for abdominal or chest surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have a history of general anesthesia in the last 6 months
Having a threatening surgical complication during the operation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R00-R09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Symptoms and signs involving the circulatory and respiratory systems</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 in the study group receive the necessary interventions as indicated in the anesthesiologist's guide. If the score is EWSS≤4, the patient is monitored every 10 minutes. If the patient's EWSS score is 5, the patient is monitored every 5 minutes. If the patient's score does not change, monitoring is continued every 5 minutes. However, if the patient's score drops to ≤4, monitoring is performed every 10 minutes. If the score increases, the follow-up will continue for 5 minutes and the emergency team will be called to evaluate the patient.</i_keyword>
      <i_keyword>Control group: All patients are scored according to EWSS during the PACU period. Patients in the control group do not receive any intervention as directed by the anesthesiologist, even if they have a high score.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Early warning scoring system score. Timepoint: Data for this period are collected after the patient is admitted to the PACU. Method of measurement: 1. Calculating the EWSS score of patients In this study, an anesthesiologist's guide is used, this guide has been prepared to achieve the standard of care by referring to published articles.</prim_outcome>
      <prim_outcome>Length of stay in PACU. Timepoint: Data for this period are collected after the patient is admitted to the PACU. Method of measurement: Record patient results: length of stay in PACU.</prim_outcome>
      <prim_outcome>Complications created in the PACU. Timepoint: Data for this period are collected after the patient is admitted to the PACU. Method of measurement: Record patient results: Complications of PACU (respiratory, pain, hypotension, nausea and vomiting, etc.).</prim_outcome>
      <prim_outcome>Complications treatment time. Timepoint: Data for this period are collected after the patient is admitted to the PACU. Method of measurement: Record patient results: Treatment time of patients' complications in recovery in minutes.</prim_outcome>
      <prim_outcome>Treatments performed. Timepoint: Data for this period are collected after the patient is admitted to the PACU. Method of measurement: Recording patient results: treatments performed for the patient by anesthesiologist (respiratory intervention, fluid therapy, positioning, additional tests, etc.).</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-05</approval_date>
        <contact_name>Ethics Committee of Ahwaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahwaz Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
