<?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>IRCT20231104059949N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-14</date_registration>
      <primary_sponsor>Zabol University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of endotracheal suction using two methods, endotracheal N-acetylcysteine and normal saline, on hemodynamic parameters and arterial blood gases in intubated patients under mechanical</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of endotracheal suction using two methods, endotracheal N-acetylcysteine and normal saline, on hemodynamic parameters and arterial blood gases in intubated patients under mechanical</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73520</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: By simple randomization method using lottery
First, three study groups are randomly assigned. Then, the code is written to the total number of the sample volume, and to allocate the samples for groups 1, 2, 3, each specified code is allocated by lottery, Blinding description: In this study, the patients are not aware of the treatment group due to the decreased level of consciousness and are kept blind. After the patient meets the conditions for entering the study, informed consent is obtained from the first-degree family members of the patient, but they do not know about the type of intervention that has been performed.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients should be intubated and under mechanical ventilation..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Endotracheal suction with N-acetylcysteine is such that 2 ml of 20% N-acetyl cysteine liquid solution is poured by the researcher into the patient's tracheal tube during suction and it is suctioned immediately. Intervention 2: Intervention group: Endotracheal suction with normal saline is done in such a way that 3 ml of sterile normal saline serum is poured by the researcher into the patient's tracheal tube during suctioning and it is suctioned immediately. Intervention 3: Control group: Endotracheal suction without inoculating solution.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Absalan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14, Farokhi Sistani St. 2, Basij Blvd., Zabul City</address>
        <city>Zabul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861866494</zip>
        <telephone>+98 54 3223 0469</telephone>
        <email>ahmadabsalan0@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Absalan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 14, Farokhi Sistani St. 2, Basij Blvd., Zabul City</address>
        <city>Zabul</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9861866494</zip>
        <telephone>+98 54 3223 0469</telephone>
        <email>ahmadabsalan0@gmail.com</email>
        <affiliation>Zabol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are connected to mechanical ventilation for at least 48 hours and at most one week
Patients with endotracheal tubes
Patients who are between 20 and 60 years old
Patients who are hemodynamically stable (heart rate between 60-100 beats per minute, blood pressure between 160/100-110/60 mmHg, Spo2 more than 90%, urinary output more than 30 ml/hour)
Patients with normal electrolyte levels and no cardiac arrhythmia
Insensitivity to N-acetylcysteine and other drugs
Absence of pulmonary edema, chronic obstructive pulmonary diseases and asthma
Patients who do not have chest trauma or chest tube
Absence of brain edema, spinal cord injury, increased intracranial pressure</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are hemodynamically unstable (heart rate less than 60 beats per minute, blood pressure less than 100/60 mmHg, Spo2 less than 90%)
Any changes in mechanical ventilation settings during the study
Death of the patient
Lack of consent of the patient's family
Use of muscle relaxants and inotropic drugs during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z99.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependence on respirator [ventilator] status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Endotracheal suction with N-acetylcysteine is such that 2 ml of 20% N-acetyl cysteine liquid solution is poured by the researcher into the patient's tracheal tube during suction and it is suctioned immediately.</i_keyword>
      <i_keyword>Intervention group: Endotracheal suction with normal saline is done in such a way that 3 ml of sterile normal saline serum is poured by the researcher into the patient's tracheal tube during suctioning and it is suctioned immediately.</i_keyword>
      <i_keyword>Control group: Endotracheal suction without inoculating solution</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate, which is considered as a hemodynamic parameter. Timepoint: The heart rate is measured at the beginning of the study (before the intervention) and 1, 5 and 30 minutes after the intervention. Method of measurement: It is controlled and recorded by means of monitoring connected to the patient.</prim_outcome>
      <prim_outcome>Blood pressure, which is considered as a hemodynamic parameter. Timepoint: The blood pressure is measured at the beginning of the study (before the intervention) and 1, 5 and 30 minutes after the intervention. Method of measurement: It is controlled and recorded by means of monitoring connected to the patient.</prim_outcome>
      <prim_outcome>Arterial oxygen saturation, which is considered as a hemodynamic parameter. Timepoint: The Arterial oxygen saturation is measured at the beginning of the study (before the intervention) and 1, 5 and 30 minutes after the intervention. Method of measurement: It is controlled and recorded by means of monitoring connected to the patient.</prim_outcome>
      <prim_outcome>Respiratory rate, which is considered as a hemodynamic parameter. Timepoint: The Respiratory rate is measured at the beginning of the study (before the intervention) and 1, 5 and 30 minutes after the intervention. Method of measurement: For 1 minute, the Respiratory rate is counted and recorded in the patient's chest by observation method.</prim_outcome>
      <prim_outcome>Arterial blood gases include PH, PCO2, PO2, HCO3, SPO2. Timepoint: Arterial blood gases are measured at the beginning of the study (5 minutes before the intervention) and 25 minutes after the intervention. Method of measurement: Blood gas Technomedica Arterial Blood Gas Analyzer Gastat-720 series.</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>Zabol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-11</approval_date>
        <contact_name>Ethics committee of Zabul University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Rajaei St., Zabul City Zabul Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
