<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/NCT03011853</url>
  </required_header>
  <id_info>
    <org_study_id>NIV4COPD</org_study_id>
    <nct_id>NCT03011853</nct_id>
  </id_info>
  <brief_title>Survival After Failed First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Survival After Failure of First-line Non-invasive Ventilation in Acute on Chronic Obstructive Pulmonary Disease: a Cohort Study of Intensive Care Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swedish Intensive Care Registry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swedish Intensive Care Registry</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational cohort study of mid-to-long term survival of patients with acute on chronic&#xD;
      obstructive pulmonary disease, analyzed per type of ventilation support provided during first&#xD;
      24 hours in intensive care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Registry setting and procedures:&#xD;
&#xD;
      The Swedish Intensive Care Registry (SIR) collects a comprehensive dataset of patient&#xD;
      characteristics, intensive care procedures and outcomes using detailed guidelines.&#xD;
&#xD;
      Continuous data are collected as raw data, validated locally and transferred electronically&#xD;
      to the registry for central validation (confirmed to be within prespecified limits and&#xD;
      inconsistencies and illogical entries identified). If necessary, data are returned for&#xD;
      correction and revalidation before being accepted and added to the master database.&#xD;
&#xD;
      Study participants:&#xD;
&#xD;
      Patients with COPD as the principal diagnosis during their ICU stay were included in the&#xD;
      study cohort. When patients had multiple admissions during the study period due to COPD the&#xD;
      last admission only was included. Patients were excluded when nursing workload scores&#xD;
      indicated active ventilation support during the first 24 hours but information on type of&#xD;
      support (non-invasive or invasive ventilation) was lacking. Participants with missing vital&#xD;
      status were also excluded from analysis.&#xD;
&#xD;
      Patients were grouped according to the mode of the first-line ventilation support that was&#xD;
      given during the initial 24 hours in ICU. The Standard therapy group did not receive any&#xD;
      active ventilation support, the NIV only group received non-invasive ventilation support&#xD;
      only, the NIV + Invasive mechanical ventilation (IMV) group received NIV followed by&#xD;
      intubation and invasive ventilation support and, the IMV group were intubated and received&#xD;
      invasive ventilation support without any preceding NIV trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2008</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Six month survival</measure>
    <time_frame>180 days</time_frame>
    <description>180 days beginning with the day of admission to ICU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>One year survival</measure>
    <time_frame>365 days</time_frame>
    <description>365 days beginning with the day of admission to ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>up to 180 days</time_frame>
    <description>From time of admission to time of discharge or death, assessed up to 180 days</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">7900</enrollment>
  <condition>Chronic Obstructive Airways Disease Exacerbated</condition>
  <condition>Critical Care</condition>
  <arm_group>
    <arm_group_label>Non-invasive only</arm_group_label>
    <description>Non-invasive ventilation as first and only respiratory support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Invasive</arm_group_label>
    <description>Invasive ventilation with intubation as first respiratory support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIV+Inv</arm_group_label>
    <description>Non-invasive ventilation as first respiratory support followed by invasive ventilation with intubation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-invasive and/or invasive mechanical ventilation</intervention_name>
    <description>Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU</description>
    <arm_group_label>Invasive</arm_group_label>
    <arm_group_label>NIV+Inv</arm_group_label>
    <arm_group_label>Non-invasive only</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted to ICUs that are members of the Swedish Intensive Care Registry and&#xD;
        participate in data collection and audit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Principal diagnosis of ICU stay: Acute on Chronic Obstructive Pulmonary Disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple admissions of patients during study period: every admission but the last one&#xD;
             is excluded.&#xD;
&#xD;
          -  Conflicting data on ventilation support&#xD;
&#xD;
          -  Vital status missing at 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sten M Walther, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Västerviks sjukhus</name>
      <address>
        <city>Vastervik</city>
        <zip>SE 59333</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <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/NCT03011853
org study id: NIV4COPD
nct id: NCT03011853
lead sponsor: 
has dmc: No
Observational cohort study of mid-to-long term survival of patients with acute on chronic
      obstructive pulmonary disease, analyzed per type of ventilation support provided during first
      24 hours in intensive care.
Registry setting and procedures:

      The Swedish Intensive Care Registry (SIR) collects a comprehensive dataset of patient
      characteristics, intensive care procedures and outcomes using detailed guidelines.

      Continuous data are collected as raw data, validated locally and transferred electronically
      to the registry for central validation (confirmed to be within prespecified limits and
      inconsistencies and illogical entries identified). If necessary, data are returned for
      correction and revalidation before being accepted and added to the master database.

      Study participants:

      Patients with COPD as the principal diagnosis during their ICU stay were included in the
      study cohort. When patients had multiple admissions during the study period due to COPD the
      last admission only was included. Patients were excluded when nursing workload scores
      indicated active ventilation support during the first 24 hours but information on type of
      support (non-invasive or invasive ventilation) was lacking. Participants with missing vital
      status were also excluded from analysis.

      Patients were grouped according to the mode of the first-line ventilation support that was
      given during the initial 24 hours in ICU. The Standard therapy group did not receive any
      active ventilation support, the NIV only group received non-invasive ventilation support
      only, the NIV + Invasive mechanical ventilation (IMV) group received NIV followed by
      intubation and invasive ventilation support and, the IMV group were intubated and received
      invasive ventilation support without any preceding NIV trial.
observational model: Cohort
time perspective: Prospective
measure: Six month survival
time frame: 180 days
description: 180 days beginning with the day of admission to ICU
measure: One year survival
time frame: 365 days
description: 365 days beginning with the day of admission to ICU
measure: ICU length of stay
time frame: up to 180 days
description: From time of admission to time of discharge or death, assessed up to 180 days
arm group label: Non-invasive only
description: Non-invasive ventilation as first and only respiratory support
arm group label: Invasive
description: Invasive ventilation with intubation as first respiratory support
arm group label: NIV+Inv
description: Non-invasive ventilation as first respiratory support followed by invasive ventilation with intubation
intervention type: Procedure
intervention name: Non-invasive and/or invasive mechanical ventilation
description: Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU
arm group label: Invasive
arm group label: NIV+Inv
arm group label: Non-invasive only
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Sten M Walther, MD PhD
role: Principal Investigator
affiliation: Linkoeping University
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No