<?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>IRCT2015072423314N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-12</date_registration>
      <primary_sponsor>Vice chancellor for research, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effects of routine versus a minimally invasive endotracheal tube suctioning procedure on suction-related pain, airway clearance, airway trauma and physiological indices in patients hospitalized in intensive care units of Al-Zahra Hospital of Isfahan in 2015.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effects of routine versus a minimally invasive endotracheal suctioning</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19913</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Respiratory conditions due to other specified external agents.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group (minimally invasive endotracheal tube suctioning) the patients were hyper oxygenated only by ventilator for one minute, short suction catheter with effective length was introduced only into the end of the endotracheal tube, a negative pressure (80-120 mmHg) was applied for a maximum duration of 10 seconds while removing the catheter, Manual hyperinflation and installation of normal saline were not applied in this group. Intervention 2: In control group (routin endotracheal tube suctioning) after disconnecting the patients from the ventilator, manual hyper oxygenation and hyperventilation was carried out for one minute, a suction catheter with an effective length was introduced into the endotracheal tube until resistance was met (reached the carina), after that it was retracted a centimeter and a negative pressure (100-200 mmHg) was applied for a maximum duration of 10 seconds while removing the catheter,  Normal saline was instilled before the each suctioning.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Shamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2917</telephone>
        <email>gezaltoshmal@yahoo.com</email>
        <affiliation>Isfahan University of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Shamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2917</telephone>
        <email>gezaltoshmal@yahoo.com</email>
        <affiliation>Isfahan university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Major inclusion criteria: age over than 18; obtaining informed consent; no blood clotting disorders; no chronic respiratory disease; intubation time between 48 hours and one week. Major exclusion criteria: extubation during the study; become unstable hemodynamic parameters such as bradycardia, arrhythmia, cyanosis, loss of arterial oxygen.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J70.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory conditions due to other specified external agents</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>In intervention group (minimally invasive endotracheal tube suctioning) the patients were hyper oxygenated only by ventilator for one minute, short suction catheter with effective length was introduced only into the end of the endotracheal tube, a negative pressure (80-120 mmHg) was applied for a maximum duration of 10 seconds while removing the catheter, Manual hyperinflation and installation of normal saline were not applied in this group.</i_keyword>
      <i_keyword>In control group (routin endotracheal tube suctioning) after disconnecting the patients from the ventilator, manual hyper oxygenation and hyperventilation was carried out for one minute, a suction catheter with an effective length was introduced into the endotracheal tube until resistance was met (reached the carina), after that it was retracted a centimeter and a negative pressure (100-200 mmHg) was applied for a maximum duration of 10 seconds while removing the catheter,  Normal saline was instilled before the each suctioning.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Immediately before, immediately after, and 10 min after endotracheal suctioning. Method of measurement: With numeral rating scale (NRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Immediately before, immediately after, and 10 min after endotracheal suctioning. Method of measurement: With vital signs monitoring devices.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: Immediately before, immediately after, and 10 min after endotracheal suctioning. Method of measurement: With vital signs monitoring devices.</sec_outcome>
      <sec_outcome>Respiratory Rate. Timepoint: Immediately before, immediately after, and 10 min after endotracheal suctioning. Method of measurement: With vital signs monitoring devices.</sec_outcome>
      <sec_outcome>Spo2. Timepoint: Immediately before, immediately after, and 10 min after endotracheal suctioning. Method of measurement: With vital signs monitoring devices.</sec_outcome>
      <sec_outcome>Number of endotracheal suctioning. Timepoint: After each endotracheal suctioning. Method of measurement: Counting the number of endotracheal suctioning.</sec_outcome>
      <sec_outcome>Airway traumatization. Timepoint: After endotracheal suctioning. Method of measurement: Viewing bleeding in the airways.</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 chancellor for research, Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-26</approval_date>
        <contact_name>Ethics committee of Isfahan university of medical sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan. Postal cod: 81746-73461 Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
