<?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>IRCT20170116031972N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-22</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of nasal care with 0.9% sodium chloride spray on pharyngeal colonization and nasal secretions in patients undergoing mechanical ventilation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of nasal care with 0.9% sodium chloride spray on pharyngeal colonization and nasal discharge in patients undergoing mechanical ventilation in intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41198</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Available randomization, block allocation.</study_design>
      <phase>1</phase>
      <hc_freetext>The effect of nasal care with 0.9% sodium chloride spray on pharyngeal colonization and nasal secretions in patients undergoing mechanical ventilation in intensive care units.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Only routine care in the intensive care unit is provided by the nurse. In this group oral rinse with 0.2% chlorhexidine solution every 6 hours (4 times a day 6_12_18_24). Nasal secretions by a nurse who is not aware of specimens assigned to the groups and throat culture by sampling the throat secretions, before study (morning shift before routine care and intervention), end of day 5 (morning shift). Sixth day before routine care and intervention) and end of day 10 (11th morning shift before routine care). Intervention 2: Intervention group: Intervention group: In this group, in addition to the usual care, an isotonic saline spray (0.9%) was sprayed by the nurse at both nostrils four times daily for 10 days by both nostrils. The time to start the study and cultivate the first time is in the morning shift before the usual care and spraying of saline is started. And how the researcher does it correctly is explained orally. Nasal secretion type by a nurse who is not aware of the specimens assigned to the groups and throat culture by sampling the throat secretions, before the study (morning shift before routine care and intervention), end of day 5 (shift Sixth morning before routine care and intervention) and end of day 10 (11th morning shift before routine care).</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnoosh Eghtedarnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of the University of Medical Sciences, the beginning of the axis of the seven Alavi gardens</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>mehrnoosheghtedarnejad@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrnoosh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of the University of Medical Sciences, the beginning of the axis of the seven Alavi gardens</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>mehrnoosheghtedarnejad@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Under aggressive mechanical ventilation
Less than 12 hours have passed since the patient entered the ward
No diagnosis of oral and lung infection before starting study with physician diagnosis
No sinusitis on arrival at diagnosis with a physician
No fractures of the face and nose
Complete occlusion of the nostril
Absence of subglottic endotracheal tube</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Transfer the patient from the ICU before completing the study
Patients with less than 10 days' hospitalization</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J34.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified disorders of nose and nasal sinuses</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Only routine care in the intensive care unit is provided by the nurse. In this group oral rinse with 0.2% chlorhexidine solution every 6 hours (4 times a day 6_12_18_24). Nasal secretions by a nurse who is not aware of specimens assigned to the groups and throat culture by sampling the throat secretions, before study (morning shift before routine care and intervention), end of day 5 (morning shift). Sixth day before routine care and intervention) and end of day 10 (11th morning shift before routine care).</i_keyword>
      <i_keyword>Intervention group: Intervention group: In this group, in addition to the usual care, an isotonic saline spray (0.9%) was sprayed by the nurse at both nostrils four times daily for 10 days by both nostrils. The time to start the study and cultivate the first time is in the morning shift before the usual care and spraying of saline is started. And how the researcher does it correctly is explained orally. Nasal secretion type by a nurse who is not aware of the specimens assigned to the groups and throat culture by sampling the throat secretions, before the study (morning shift before routine care and intervention), end of day 5 (shift Sixth morning before routine care and intervention) and end of day 10 (11th morning shift before routine care).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effect of nasal care with 0.9% sodium chloride spray on throat colonization and nasal secretions. Timepoint: In the control group, mouthwash is administered with 0.2% chlorhexidine solution every 6 hours (4 times a day 6/12_18_24). In the intervention group (nasal care) In addition to receiving routine care, an isotonic saline spray puff (0.9%) was sprayed by the nurse simultaneously with mouthwash four times daily in both nostrils for 10 days. Method of measurement: Background information questionnaire and nasal discharge survey and sampling of throat discharge are used for data collection.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-29</approval_date>
        <contact_name>Kerman University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Campus of the University of Medical Sciences, the beginning of the axis of the seven Alavi gardens Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
