<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/NCT03800849</url>
  </required_header>
  <id_info>
    <org_study_id>Ventilation</org_study_id>
    <nct_id>NCT03800849</nct_id>
  </id_info>
  <brief_title>Mechanical Ventilation Practices in Uganda's Intensive Care Units</brief_title>
  <official_title>Mechanical Ventilation Practices and 28-day Patient Mortality in Uganda's Intensive Care Units: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makerere University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and&#xD;
      above initiated on mechanical ventilation will be recruited. Patients' data will be collected&#xD;
      from the files and charts at initiation of mechanical ventilation. Patients will then be&#xD;
      followed up for death / discharge within 28 days in ICU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The need for mechanical ventilation is one of the commonest indication for&#xD;
      admission to the ICU. Despite the clear benefits of mechanical ventilation, it may be&#xD;
      detrimental to the patient if poorly carried out. This has led to a renewed impetus in&#xD;
      employing lung protective ventilation strategies, Ventilator Associated Events (VAE)&#xD;
      prevention strategies, and safe and appropriate weaning methods to reduce mortality among&#xD;
      mechanically ventilated patients. However, there is paucity of data regarding these practices&#xD;
      in low-income settings.&#xD;
&#xD;
      Objective: To describe the mechanical ventilation practices, mortality rate and associated&#xD;
      factors among mechanically ventilated patients in Uganda's intensive care units.&#xD;
&#xD;
      Methodology: A prospective cohort study carried out in four ICUs in Uganda. All patients, 18&#xD;
      years and above initiated on mechanical ventilation will be recruited. Patients' data will be&#xD;
      collected from the files and charts at initiation of mechanical ventilation. Patients will&#xD;
      then be followed up for death / discharge within 28 days in ICU.&#xD;
&#xD;
      Data analysis: The primary outcome is all-cause mortality during ICU stay. Data will be&#xD;
      summarised into means and standard deviations, medians and interquartile ranges and presented&#xD;
      in tables, charts, cross-tabulations and graphs. Univariate and multivariate logistic&#xD;
      regression will be used to determine factors associated with mortality.&#xD;
&#xD;
      Utility of results: The results from this study will be disseminated to the Ministry of&#xD;
      Health and Makerere University in order to plan, standardise and form guidelines regarding&#xD;
      mechanical ventilation practices in ICUs in Uganda.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 14, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 14, 2019</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>28 day ICU mortality of mechanically ventilated patients</measure>
    <time_frame>7 months</time_frame>
    <description>Patients will be followed up either to discharge or death in ICU to a maximum of 28 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation, ventilatory settings used, use of complementary ICU interventions</measure>
    <time_frame>7 months</time_frame>
    <description>At discharge, death or at the end of 28 days, the duration of mechanical ventilation, ventilatory settings used and complementary interventions will be described.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">214</enrollment>
  <condition>Mechanically Ventilated Patients</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Mechanically ventilated Adult patients in four selected ICUs during the study period who&#xD;
        meet the inclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients 18 years and above, initiated on mechanical ventilation, admitted&#xD;
             into study ICU during the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients ventilated in another ICU for more than 24 hours and transferred to study&#xD;
             ICUs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Kyamummi, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makerere University, Kampala</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Irene Kyamummi, MBChB</last_name>
    <phone>701 833 144</phone>
    <phone_ext>256</phone_ext>
    <email>ikyamummi@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mulago hospital</name>
      <address>
        <city>Kampala</city>
        <zip>256</zip>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ponsiano Ocama, PHD</last_name>
      <phone>0772421190</phone>
      <phone_ext>256</phone_ext>
      <email>ponsiano.ocama@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03800849
org study id: Ventilation
nct id: NCT03800849
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A prospective cohort study carried out in four ICUs in Uganda. All patients, 18 years and
      above initiated on mechanical ventilation will be recruited. Patients' data will be collected
      from the files and charts at initiation of mechanical ventilation. Patients will then be
      followed up for death / discharge within 28 days in ICU.
Background: The need for mechanical ventilation is one of the commonest indication for
      admission to the ICU. Despite the clear benefits of mechanical ventilation, it may be
      detrimental to the patient if poorly carried out. This has led to a renewed impetus in
      employing lung protective ventilation strategies, Ventilator Associated Events (VAE)
      prevention strategies, and safe and appropriate weaning methods to reduce mortality among
      mechanically ventilated patients. However, there is paucity of data regarding these practices
      in low-income settings.

      Objective: To describe the mechanical ventilation practices, mortality rate and associated
      factors among mechanically ventilated patients in Uganda's intensive care units.

      Methodology: A prospective cohort study carried out in four ICUs in Uganda. All patients, 18
      years and above initiated on mechanical ventilation will be recruited. Patients' data will be
      collected from the files and charts at initiation of mechanical ventilation. Patients will
      then be followed up for death / discharge within 28 days in ICU.

      Data analysis: The primary outcome is all-cause mortality during ICU stay. Data will be
      summarised into means and standard deviations, medians and interquartile ranges and presented
      in tables, charts, cross-tabulations and graphs. Univariate and multivariate logistic
      regression will be used to determine factors associated with mortality.

      Utility of results: The results from this study will be disseminated to the Ministry of
      Health and Makerere University in order to plan, standardise and form guidelines regarding
      mechanical ventilation practices in ICUs in Uganda.
observational model: Cohort
time perspective: Prospective
measure: 28 day ICU mortality of mechanically ventilated patients
time frame: 7 months
description: Patients will be followed up either to discharge or death in ICU to a maximum of 28 days
measure: Duration of mechanical ventilation, ventilatory settings used, use of complementary ICU interventions
time frame: 7 months
description: At discharge, death or at the end of 28 days, the duration of mechanical ventilation, ventilatory settings used and complementary interventions will be described.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Irene Kyamummi, MBChB
role: Principal Investigator
affiliation: Makerere University, Kampala
last name: Irene Kyamummi, MBChB
phone: 701 833 144
phone ext: 256
email: ikyamummi@yahoo.com
facility: 
status: Recruiting
contact: 
country: Uganda
responsible party type: Sponsor