<?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>IRCT20230719058854N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-24</date_registration>
      <primary_sponsor>Vice-Chancellery for Research Hormozgan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of different levels of positive end-expiratory pressure on respiratory function in laparoscopic cholecystectomy candidates</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of different levels of positive end-expiratory pressure on the respiratory function in laparoscopic cholecystectomy candidates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71465</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomized into two groups using simple randomization with individuals as the unit of randomization and a randomization table produced by the Random Allocation software. An individual uninvolved in the study will write A or B or C on a card and put it in an opaque envelope. Then the associated number in the randomization table will be written on the back of the envelope. One envelope will be allocated to each patient in order of entrance to the study. Allocation concealment will be done using opaque envelopes, Blinding description: The individual responsible for the assessment of hemodynamic and respiratory parameters will be unaware of patient grouping, while given the nature of the intervention and that there is no placebo, the patient and those related to the patient will not be blinded. Therefore, the study will be single-blind with blinding the assessor.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Respiratory support during elective laparoscopic cholecystectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Positive end-expiratory pressure of 5 cm H2O. Intervention 2: Intervention group: Positive end-expiratory pressure of 7 cm H2O. Intervention 3: Control group: Positive end-expiratory pressure of 0 cm H2O.</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>Zohre Nikeghbali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Across from Kargaran Sports Complex, Imam Hossein Blvd., Bandar Abbas, Hormozgan, Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919693116</zip>
        <telephone>+98 76 3371 0393</telephone>
        <email>zohrenikeghbal77@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohre Nikeghbali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Across from Kargaran Sports Complex, Imam Hossein Blvd., Bandar Abbas, Hormozgan, Iran</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7919693116</zip>
        <telephone>+98 76 3371 0393</telephone>
        <email>zohrenikeghbal77@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-70 years
ASA class I and II</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hemodynamic instability
Severe heart failure
Renal failure
Respiratory failure
Pulmonary embolism
Air embolism during the operation
Complications of laparoscopy leading to laparotomy
History of chronic respiratory diseases, asthma, and chronic obstructive pulmonary disease</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Positive end-expiratory pressure of 5 cm H2O</i_keyword>
      <i_keyword>Intervention group: Positive end-expiratory pressure of 7 cm H2O</i_keyword>
      <i_keyword>Control group: Positive end-expiratory pressure of 0 cm H2O</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Partial pressure of arterial oxygen. Timepoint: 30 min after intubation. Method of measurement: Arterial blood gas (ABG).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Partial pressure of carbon dioxide in arterial blood. Timepoint: 30 min after intubation. Method of measurement: Arterial blood gas (ABG).</sec_outcome>
      <sec_outcome>PH. Timepoint: 30 min after intubation. Method of measurement: Arterial blood gas (ABG).</sec_outcome>
      <sec_outcome>End-tidal carbon dioxide (EtCO2). Timepoint: Some minutes before laryngoscopy, during laryngoscopy, and then 15, 30, and 60 min after intubation. Method of measurement: Capnography.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Some minutes before laryngoscopy, during laryngoscopy, and then 15, 30, and 60 min after intubation, and after extubation in the recovery unit. Method of measurement: The monitoring device.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Some minutes before laryngoscopy, during laryngoscopy, and then 15, 30, and 60 min after intubation, and after extubation in the recovery unit. Method of measurement: The monitoring device.</sec_outcome>
      <sec_outcome>Oxygen saturation (SpO2). Timepoint: Some minutes before laryngoscopy, during laryngoscopy, and then 15, 30, and 60 min after intubation, and after extubation in the recovery unit. Method of measurement: Pulse oximeter.</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>Vice-Chancellery for Research Hormozgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-08</approval_date>
        <contact_name>Ethics Committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Faculty of Medicine, Across from Kargaran Sports Complex, Imam Hossein Blvd. Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
