<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/NCT03255109</url>
  </required_header>
  <id_info>
    <org_study_id>WEAN SAFE</org_study_id>
    <nct_id>NCT03255109</nct_id>
  </id_info>
  <brief_title>WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE</brief_title>
  <acronym>WEAN SAFE</acronym>
  <official_title>WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From Ventilatory assistancE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Society of Intensive Care Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Society of Intensive Care Medicine</source>
  <oversight_info>
    <has_dmc>Yes</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>
      WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE) is a&#xD;
      multi-centre, prospective, observational, 4-week inception cohort study being carried out by&#xD;
      the Acute Respiratory Failure section of ESICM. Weaning represents a challenge for&#xD;
      intensivists and patients spend a considerable amount of time in being liberated from&#xD;
      mechanical ventilation. While guidelines do exist on the classification of weaning, a recent&#xD;
      study has shown that these may not be applicable to all patients. Moreover, different&#xD;
      practices exist in regard to weaning procedures. WEAN SAFE will prospectively assess the&#xD;
      burden of, management and spectrum of approaches to weaning from ventilation, in patients&#xD;
      that require invasive mechanical ventilation for any reason, for a time period of at least 24&#xD;
      hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to describe, in a large population of ICU patients the burden&#xD;
      of, management and spectrum of approaches to weaning from ventilation, in patients that&#xD;
      require invasive mechanical ventilation for any reason, for a time period of at least 24&#xD;
      hours. It will answer the following questions:&#xD;
&#xD;
        -  What are the current approaches taken to wean patients from invasive mechanical&#xD;
           ventilation?&#xD;
&#xD;
        -  What is the frequency of delayed weaning from invasive mechanical ventilation?&#xD;
&#xD;
        -  What are the factors that are used to determine when patients are in the weaning phase?&#xD;
&#xD;
        -  What are the barriers to effective weaning from invasive MV?&#xD;
&#xD;
        -  What factors (patient, institutional, medical practice) contribute to failed attempts to&#xD;
           wean from invasive mechanical ventilation?&#xD;
&#xD;
        -  What is the impact of premorbid conditions on weaning from invasive MV?&#xD;
&#xD;
        -  What is the utility of existing classifications for weaning from invasive MV?&#xD;
&#xD;
        -  What is the impact of early versus delayed and/or failed weaning from invasive MV?&#xD;
&#xD;
      Patients will be screened for the study when undergoing mechanical ventilation and admitted&#xD;
      in the ICU.&#xD;
&#xD;
      Day 1 will be defined as the first day when IMV commences Day 2 commences at 6-10am (fixed&#xD;
      time point each day per ICU practice) after IMV commences. Patients undergoing invasive&#xD;
      mechanical ventilation on the morning of day 1 will be screened for the study Patients still&#xD;
      undergoing IMV on Day 2, will be enrolled in the study Patients not undergoing invasive&#xD;
      mechanical ventilation or liberated from invasive mechanical ventilation on day 1 will be&#xD;
      re-evaluated daily for the presence of inclusion criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 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>90 Days</target_duration>
  <primary_outcome>
    <measure>The number of patients invasively ventilated in the last 24 hours</measure>
    <time_frame>90 days or hospital discharge (whichever occurs first)</time_frame>
    <description>To describe the frequency of simple, difficult and prolonged weaning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The current approaches taken to wean patients from invasive mechanical ventilation and impact on weaning duration</measure>
    <time_frame>90 days or hospital discharge (whichever occurs first)</time_frame>
    <description>What are the factors ((patient, institutional, medical practice) that are used to determine when patients are in the weaning phase</description>
  </secondary_outcome>
  <enrollment type="Actual">11000</enrollment>
  <condition>Acute Severe Respiratory Failure</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Due to the observational nature of the present study, patients enrolled in other&#xD;
        observational/interventional study CAN be enrolled in the present study.&#xD;
&#xD;
        We aim to collect a large &quot;convenience sample&quot;, with &gt; 5,000 patients. Based on the LUNG&#xD;
        SAFE data (NCT02010073; JAMA, 2016 Jul 19;316(3):347), we can estimate to enroll about 11&#xD;
        patients invasively ventilated on Day 2 following intubation per participating ICU in a 4&#xD;
        week period. We are therefore targeting the enrollment of 500 registered ICUs (considering&#xD;
        a 10% dropout)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Screening: all patients admitted in the ICU and aged &gt;16 will be screened daily&#xD;
&#xD;
        - A patient will be included if he/she is undergoing Invasive mechanical ventilation on the&#xD;
        second morning (between 6am and 10 am) after initiation of mechanical ventilation or after&#xD;
        ICU admission (if ventilation was already in place).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent (where required)&#xD;
&#xD;
          -  Patients already present in the ICU at the beginning of the study, independently of&#xD;
             the form of ventilatory support&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>John LAFFEY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Galway, Ireland and St Michael's Hospital-University of Toronto, Canada</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giacomo BELLANI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>S Gerardo Hospital, University of Milan-Bicocca, Monza, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>All Centres From All Over the World Willing to Contribute Are Welcome</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.esicm.org/research/WEAN-SAFE</url>
    <description>webpage on Wean Safe where more useful details can be found such as the link to register your site</description>
  </link>
  <reference>
    <citation>Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.</citation>
    <PMID>17470624</PMID>
  </reference>
  <reference>
    <citation>Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.</citation>
    <PMID>17962636</PMID>
  </reference>
  <reference>
    <citation>McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.</citation>
    <PMID>23215559</PMID>
  </reference>
  <reference>
    <citation>Fagon JY, Chastre J, Vuagnat A, Trouillet JL, Novara A, Gibert C. Nosocomial pneumonia and mortality among patients in intensive care units. JAMA. 1996 Mar 20;275(11):866-9.</citation>
    <PMID>8596225</PMID>
  </reference>
  <reference>
    <citation>Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998 Aug;158(2):489-93. doi: 10.1164/ajrccm.158.2.9711045.</citation>
    <PMID>9700126</PMID>
  </reference>
  <reference>
    <citation>Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.</citation>
    <PMID>23641924</PMID>
  </reference>
  <reference>
    <citation>Blackwood B, Alderdice F, Burns K, Cardwell C, Lavery G, O'Halloran P. Use of weaning protocols for reducing duration of mechanical ventilation in critically ill adult patients: Cochrane systematic review and meta-analysis. BMJ. 2011 Jan 13;342:c7237. doi: 10.1136/bmj.c7237.</citation>
    <PMID>21233157</PMID>
  </reference>
  <reference>
    <citation>Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.</citation>
    <PMID>8948561</PMID>
  </reference>
  <reference>
    <citation>Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.</citation>
    <PMID>18191684</PMID>
  </reference>
  <reference>
    <citation>Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.</citation>
    <PMID>27626706</PMID>
  </reference>
  <reference>
    <citation>Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.</citation>
    <PMID>26903337</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung</keyword>
  <keyword>acute</keyword>
  <keyword>respiratory</keyword>
  <keyword>distress</keyword>
  <keyword>weaning</keyword>
  <keyword>mechanical ventilation</keyword>
  <keyword>respiratory infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Acute Lung Injury</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/NCT03255109
org study id: WEAN SAFE
nct id: NCT03255109
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE) is a
      multi-centre, prospective, observational, 4-week inception cohort study being carried out by
      the Acute Respiratory Failure section of ESICM. Weaning represents a challenge for
      intensivists and patients spend a considerable amount of time in being liberated from
      mechanical ventilation. While guidelines do exist on the classification of weaning, a recent
      study has shown that these may not be applicable to all patients. Moreover, different
      practices exist in regard to weaning procedures. WEAN SAFE will prospectively assess the
      burden of, management and spectrum of approaches to weaning from ventilation, in patients
      that require invasive mechanical ventilation for any reason, for a time period of at least 24
      hours.
The purpose of this study is to describe, in a large population of ICU patients the burden
      of, management and spectrum of approaches to weaning from ventilation, in patients that
      require invasive mechanical ventilation for any reason, for a time period of at least 24
      hours. It will answer the following questions:

        -  What are the current approaches taken to wean patients from invasive mechanical
           ventilation?

        -  What is the frequency of delayed weaning from invasive mechanical ventilation?

        -  What are the factors that are used to determine when patients are in the weaning phase?

        -  What are the barriers to effective weaning from invasive MV?

        -  What factors (patient, institutional, medical practice) contribute to failed attempts to
           wean from invasive mechanical ventilation?

        -  What is the impact of premorbid conditions on weaning from invasive MV?

        -  What is the utility of existing classifications for weaning from invasive MV?

        -  What is the impact of early versus delayed and/or failed weaning from invasive MV?

      Patients will be screened for the study when undergoing mechanical ventilation and admitted
      in the ICU.

      Day 1 will be defined as the first day when IMV commences Day 2 commences at 6-10am (fixed
      time point each day per ICU practice) after IMV commences. Patients undergoing invasive
      mechanical ventilation on the morning of day 1 will be screened for the study Patients still
      undergoing IMV on Day 2, will be enrolled in the study Patients not undergoing invasive
      mechanical ventilation or liberated from invasive mechanical ventilation on day 1 will be
      re-evaluated daily for the presence of inclusion criteria.
observational model: Cohort
time perspective: Prospective
measure: The number of patients invasively ventilated in the last 24 hours
time frame: 90 days or hospital discharge (whichever occurs first)
description: To describe the frequency of simple, difficult and prolonged weaning
measure: The current approaches taken to wean patients from invasive mechanical ventilation and impact on weaning duration
time frame: 90 days or hospital discharge (whichever occurs first)
description: What are the factors ((patient, institutional, medical practice) that are used to determine when patients are in the weaning phase
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
last name: John LAFFEY, MD
role: Principal Investigator
affiliation: National University of Galway, Ireland and St Michael's Hospital-University of Toronto, Canada
last name: Giacomo BELLANI, MD
role: Principal Investigator
affiliation: S Gerardo Hospital, University of Milan-Bicocca, Monza, Italy
facility: 
country: Belgium
url: http://www.esicm.org/research/WEAN-SAFE
description: webpage on Wean Safe where more useful details can be found such as the link to register your site
citation: Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PMID: 17470624
citation: Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.
PMID: 17962636
citation: McConville JF, Kress JP. Weaning patients from the ventilator. N Engl J Med. 2012 Dec 6;367(23):2233-9. doi: 10.1056/NEJMra1203367. No abstract available.
PMID: 23215559
citation: Fagon JY, Chastre J, Vuagnat A, Trouillet JL, Novara A, Gibert C. Nosocomial pneumonia and mortality among patients in intensive care units. JAMA. 1996 Mar 20;275(11):866-9.
PMID: 8596225
citation: Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. 1998 Aug;158(2):489-93. doi: 10.1164/ajrccm.158.2.9711045.
PMID: 9700126
citation: Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
PMID: 23641924
citation: Blackwood B, Alderdice F, Burns K, Cardwell C, Lavery G, O'Halloran P. Use of weaning protocols for reducing duration of mechanical ventilation in critically ill adult patients: Cochrane systematic review and meta-analysis. BMJ. 2011 Jan 13;342:c7237. doi: 10.1136/bmj.c7237.
PMID: 21233157
citation: Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.
PMID: 8948561
citation: Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
PMID: 18191684
citation: Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
PMID: 27626706
citation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
PMID: 26903337
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
sharing ipd: No