<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03790150</url>
  </required_header>
  <id_info>
    <org_study_id>RC 17/223</org_study_id>
    <nct_id>NCT03790150</nct_id>
  </id_info>
  <brief_title>National Approach to Standardize and Improve Mechanical Ventilation</brief_title>
  <acronym>NASAM</acronym>
  <official_title>National Approach to Standardize and Improve Mechanical Ventilation Care for Critically Ill Patients in Saudi Arabia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdullah International Medical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King Abdullah International Medical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pre-post implementation cohort study. This is a data driven quality improvement&#xD;
      project which aims to improve the care of mechanically ventilated patients through the&#xD;
      implementation of a bundle of evidence based practices, with a goal of reducing ventilator&#xD;
      associated events and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NASAM is a national collaborative quality improvement project in Saudi Arabia which aims to:&#xD;
&#xD;
        1. Reduce the rate of ventilator-associated events&#xD;
&#xD;
        2. Improve the compliance with NASAM bundle elements&#xD;
&#xD;
        3. Reduce the mortality of mechanically ventilated patients&#xD;
&#xD;
      The plan of this quality improvement project is to extend the implementation to a total of&#xD;
      100 ICUs in collaboration with multiple health systems across the country. A significant&#xD;
      component of this project includes measuring the safety culture of ICUs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ventilator-associated events</measure>
    <time_frame>18 months</time_frame>
    <description>Ventilator-associated events rate per 1000 ventilator days in 18 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sub-glottic endotracheal tube compliance rate</measure>
    <time_frame>18 months</time_frame>
    <description>The percentage of ventilator days with sub-glottic endotracheal tube use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head of bed elevation compliance rate</measure>
    <time_frame>18 months</time_frame>
    <description>The percentage of ventilator days with head of bed elevation ≥30 degrees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous awakening trial (SAT) compliance rate</measure>
    <time_frame>18 months</time_frame>
    <description>The percentage of ventilator days with spontaneous awakening trial (SAT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of ventilated patient days without sedation</measure>
    <time_frame>18 months</time_frame>
    <description>The percentage of ventilated patient days without sedation use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous breathing trials (SBT) compliance rate</measure>
    <time_frame>18 months</time_frame>
    <description>The percentage of ventilator days with spontaneous breathing trial (SBT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of ventilated patient days without neuromuscular blockers</measure>
    <time_frame>18 months</time_frame>
    <description>The percentage of ventilated patient days without neuromuscular blockers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of out of bed mobility</measure>
    <time_frame>18 months</time_frame>
    <description>The percentage of ventilated patient days with out of bed mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of CAM-ICU negative (no delirium)</measure>
    <time_frame>18 months</time_frame>
    <description>The percentage of ventilator days with CAM-ICU negative (no delirium)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90 days</time_frame>
    <description>The 90-day ICU mortality rate of ventilated patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation duration</measure>
    <time_frame>90 days</time_frame>
    <description>The duration of mechanical ventilation in calendar days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>90 days</time_frame>
    <description>The number of calendar days from ICU admission to discharge from ICU</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">27966</enrollment>
  <condition>Mechanical Ventilation Complication</condition>
  <arm_group>
    <arm_group_label>Mechanically Ventilated Patients</arm_group_label>
    <description>All patients admitted to the critical care unit and require mechanical ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evidence-based practices</intervention_name>
    <description>Implementation of evidence-based practices</description>
    <arm_group_label>Mechanically Ventilated Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mechanically ventilated patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients admitted to intensive care units&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 14 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaseen M Arabi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Abdullah Medical City, Ministry of National Guard Health Affairs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs</name>
      <address>
        <city>Riyadh</city>
        <zip>11426</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Abdullah International Medical Research Center</name>
      <address>
        <city>Riyadh</city>
        <zip>22490</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>March 12, 2023</last_update_submitted>
  <last_update_submitted_qc>March 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdullah International Medical Research Center</investigator_affiliation>
    <investigator_full_name>Dr Yaseen Arabi</investigator_full_name>
    <investigator_title>Chairman, Intensive Care Unit</investigator_title>
  </responsible_party>
  <keyword>Ventilator-associated pneumonia</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Ventilator-associated events</keyword>
  <keyword>Intensive care unit</keyword>
  <keyword>Quality improvement project</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03790150
org study id: RC 17/223
nct id: NCT03790150
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pre-post implementation cohort study. This is a data driven quality improvement
      project which aims to improve the care of mechanically ventilated patients through the
      implementation of a bundle of evidence based practices, with a goal of reducing ventilator
      associated events and mortality.
NASAM is a national collaborative quality improvement project in Saudi Arabia which aims to:

        1. Reduce the rate of ventilator-associated events

        2. Improve the compliance with NASAM bundle elements

        3. Reduce the mortality of mechanically ventilated patients

      The plan of this quality improvement project is to extend the implementation to a total of
      100 ICUs in collaboration with multiple health systems across the country. A significant
      component of this project includes measuring the safety culture of ICUs.
observational model: Cohort
time perspective: Prospective
measure: Ventilator-associated events
time frame: 18 months
description: Ventilator-associated events rate per 1000 ventilator days in 18 months
measure: Sub-glottic endotracheal tube compliance rate
time frame: 18 months
description: The percentage of ventilator days with sub-glottic endotracheal tube use
measure: Head of bed elevation compliance rate
time frame: 18 months
description: The percentage of ventilator days with head of bed elevation ≥30 degrees
measure: Spontaneous awakening trial (SAT) compliance rate
time frame: 18 months
description: The percentage of ventilator days with spontaneous awakening trial (SAT)
measure: Percentage of ventilated patient days without sedation
time frame: 18 months
description: The percentage of ventilated patient days without sedation use
measure: Spontaneous breathing trials (SBT) compliance rate
time frame: 18 months
description: The percentage of ventilator days with spontaneous breathing trial (SBT)
measure: Percentage of ventilated patient days without neuromuscular blockers
time frame: 18 months
description: The percentage of ventilated patient days without neuromuscular blockers
measure: Percentage of out of bed mobility
time frame: 18 months
description: The percentage of ventilated patient days with out of bed mobility
measure: Percentage of CAM-ICU negative (no delirium)
time frame: 18 months
description: The percentage of ventilator days with CAM-ICU negative (no delirium)
measure: 90-day mortality
time frame: 90 days
description: The 90-day ICU mortality rate of ventilated patients
measure: Mechanical ventilation duration
time frame: 90 days
description: The duration of mechanical ventilation in calendar days
measure: ICU length of stay
time frame: 90 days
description: The number of calendar days from ICU admission to discharge from ICU
arm group label: Mechanically Ventilated Patients
description: All patients admitted to the critical care unit and require mechanical ventilation
intervention type: Other
intervention name: Evidence-based practices
description: Implementation of evidence-based practices
arm group label: Mechanically Ventilated Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Yaseen M Arabi, MD
role: Principal Investigator
affiliation: King Abdullah Medical City, Ministry of National Guard Health Affairs
facility: 
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Abdullah International Medical Research Center
investigator full name: Dr Yaseen Arabi
investigator title: Chairman, Intensive Care Unit
sharing ipd: No