<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/NCT03249623</url>
  </required_header>
  <id_info>
    <org_study_id>226610</org_study_id>
    <secondary_id>2017-002627-25</secondary_id>
    <nct_id>NCT03249623</nct_id>
  </id_info>
  <brief_title>Individualised Weaning From Mechanical Ventilation in General ICU</brief_title>
  <acronym>iCareWean_CW</acronym>
  <official_title>Weaning From Mechanical Ventilation: Comparison of Open-Loop Decision Support System and Routine Care, in the General Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chelsea and Westminster NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chelsea and Westminster NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients residing in the intensive care unit typically receive mechanical ventilatory&#xD;
      support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has&#xD;
      been shown that lung protective settings can reduce mortality in patients with lung injury.&#xD;
      Despite being a life- saving therapy, duration of mechanical ventilation should be kept at a&#xD;
      minimum to reduce effects of immobilization, long-term sedation, patient discomfort, risk of&#xD;
      ventilator associated pneumonia, leading to decreasing mortality and economic costs etc. The&#xD;
      duration of mechanical ventilation is also an important factor in weaning from ventilatory&#xD;
      support, with prolonged ventilator support making the weaning process more difficult.&#xD;
&#xD;
      The purpose of this study is to compare mechanical ventilation following advice from the&#xD;
      Beacon Caresystem to that of standard care in general medical intensive care unit (ICU)&#xD;
      patients, from the start of requiring invasive mechanical ventilation until successful&#xD;
      extubation. The Beacon Caresystem will be compared to standard care to investigate whether&#xD;
      use of the system results in similar care or reduced time for weaning from mechanical&#xD;
      ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients admitted to the ICU with mechanical ventilation are screened for inclusion.&#xD;
      Patients receiving invasive mechanical ventilation (≥ 24 h) will be considered for inclusion&#xD;
      in the study on a daily basis. Patient screening will be performed by clinical researchers or&#xD;
      a delegated clinician and consent/assent will be sought. Then patients will be randomised to&#xD;
      the Beacon group or Standard Care group. Randomisation will be performed using sealed&#xD;
      envelopes, and in blocks of patients, allowing interim analysis of results in appropriate&#xD;
      steps during the study. To avoid that results are affected by patient disease type,&#xD;
      randomisation will be stratified for equal distribution between randomisation groups.&#xD;
&#xD;
      Patients will be randomly assigned to either standard care of mechanical ventilation, or to&#xD;
      follow the advice of the Beacon Caresystem. The results of these two strategies will then be&#xD;
      compared based upon the following outcome measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 11, 2017</start_date>
  <completion_date type="Anticipated">July 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>After randomisation, for patients randomised in the Beacon group, the Beacon system will actively advice clinicians on ventilatory settings to adapt the ventilator to patient's individual clinical situation and corresponding clinical intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of mechanical ventilation</measure>
    <time_frame>Daily assessment of requirement of mechanical ventilation from the time of randomisation until the date of liberation from mechanical ventilation, up to 12 months.</time_frame>
    <description>Length of mechanical ventilation, defined as either the time of intubation in the ICU, or the time of admission to the ICU following previous intubation for surgery, and until successful extubation, with successful</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to spontaneous ventilation</measure>
    <time_frame>Daily assessment of spontaneous ventilation from the date of randomisation until the date the patient starts breathing spontaneously, up to 12 months.</time_frame>
    <description>It is defined as the time taken to wean from mandatory mode of ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to extubation</measure>
    <time_frame>Daily assessment of time to extubation from the date of initiation of spontaneous ventilation until the date of liberation from mechanical ventilation, up to 12 months.</time_frame>
    <description>It is defined as the time the decision is made to proceed with removal of the endotracheal tube or tracheal decannulation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">274</enrollment>
  <condition>Ventilatory Failure</condition>
  <arm_group>
    <arm_group_label>Beacon Caresystem</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On randomisation to the Beacon group, a Beacon Caresystem will be connected to the patient. This involves connecting a pulse oximeter to the patient's finger (toe or ear) to measure pulse oximetry oxygen saturation and pulse, and placing a standard clinical respiratory gas analysis and flow sensor in the respiratory tubing connecting the ventilator to the patient. This sensor allows measurement of respiratory pressure, flow and volume; plus respiratory gas CO2 and O2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For this group mechanical ventilation is managed according to standard care. A Beacon CareSystem will be connected to the patient, as for the Beacon Randomisation group, but the system will be used solely for data collection, and advice will be disabled. Physiological variables captured in this arm of the study will mirror the intervention arm. Decision relating to weaning, extubation, reintubation and sedation including level of seniority of personnel involved in the decision tree process will be documented accordingly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Beacon Caresystem</intervention_name>
    <description>The core of the system is a set of physiological models including pulmonary gas exchange, acid-base chemistry, lung mechanics, and respiratory drive. The Beacon Caresystem tunes these models to the individual patient such that they describe accurately current measurements. Once tuned, the models are used by the system to simulate the effects of changing ventilator settings. The results of these simulations are then used calculate the clinical benefit of changing ventilator settings by balancing the competing goals of mechanical ventilation.</description>
    <arm_group_label>Beacon Caresystem</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is expected to be on invasive mechanical ventilation more 24 hours.&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Haemodynamically stable (with instability defined by the presence of two or more of&#xD;
             the following criteria: acidosis pH &lt; 7.2, poor urine output &lt; 0.5ml/kg, use of&#xD;
             vasopressors, e.g. noradrenline &gt; 25 μg/min).&#xD;
&#xD;
          -  Patient consent or, in the case that the patient is unable, assent from the next of&#xD;
             kin or treating physician following understanding and accept of oral and written&#xD;
             information describing the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The absence of an arterial catheter for blood sampling at study start.&#xD;
&#xD;
          -  Medical history of home mechanical ventilation which may lead to prolonged stay in the&#xD;
             ICU, including long term oxygen therapy and non-invasive ventilation not associated&#xD;
             with sleep apnoa.&#xD;
&#xD;
          -  Clinical conditions requiring treatment with extracorporeal membrane oxygenation, i.e.&#xD;
             an inspired oxygen of 100% for more than 24 hours.&#xD;
&#xD;
          -  Head trauma or other conditions where intra-cranial pressure may be elevated and tight&#xD;
             regulation of arterial CO2 level is paramount.&#xD;
&#xD;
          -  Primary neurological patients (Glasgow coma score &lt;10, neurologic damage with limited&#xD;
             prognosis, stroke hemiplegia).&#xD;
&#xD;
          -  Severe heart failure, classified as grade 4 of the Association of Cardiology&#xD;
             guidelines [2].&#xD;
&#xD;
          -  End stage liver disease.&#xD;
&#xD;
          -  Multiple medical ICU admissions, i.e. more than one admission.&#xD;
&#xD;
          -  Corrective orthognathic surgery.&#xD;
&#xD;
          -  Esophageal surgery.&#xD;
&#xD;
          -  Morbidly obese patients defined as either BMI&gt;45, or 35&lt;BMI&lt;45 with APACHEII score on&#xD;
             admission greater than 24.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Mechanical ventilation initiated for more for 24 hours in other centers&#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>Marcela P Vizcaychipi, MD PhD FFICM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chelsea and Westminster NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Damon P Foster</last_name>
    <phone>+44 2033156887</phone>
    <phone_ext>56887</phone_ext>
    <email>essam.ramhamadany@chelwest.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stephen Rees, PhD</last_name>
    <phone>+45 30328469</phone>
    <email>sr@hst.aau.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Magill Department of Anaesthesia, Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James R White, MBBS</last_name>
      <phone>+447539729847</phone>
      <email>James.white2@chelwest.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Margaret Smyth</last_name>
      <phone>+447584640699</phone>
      <email>Margaret.smyth@chelwest.nhs.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.chelwest.nhs.uk</url>
    <description>Sponsor website</description>
  </link>
  <results_reference>
    <citation>Rees SE, Karbing DS. Determining the appropriate model complexity for patient-specific advice on mechanical ventilation. Biomed Tech (Berl). 2017 Apr 1;62(2):183-198. doi: 10.1515/bmt-2016-0061.</citation>
    <PMID>27930361</PMID>
  </results_reference>
  <results_reference>
    <citation>Rees SE, Karbing DS. Model-based advice for mechanical ventilation: From research (INVENT) to product (Beacon Caresystem). Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:5331-4. doi: 10.1109/EMBC.2015.7319595.</citation>
    <PMID>26737495</PMID>
  </results_reference>
  <results_reference>
    <citation>Weinreich UM, Thomsen LP, Rees SE, Rasmussen BS. The effects of oxygen induced pulmonary vasoconstriction on bedside measurement of pulmonary gas exchange. J Clin Monit Comput. 2016 Apr;30(2):207-14. doi: 10.1007/s10877-015-9703-x. Epub 2015 May 12.</citation>
    <PMID>25962614</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Weaning</keyword>
  <keyword>Intensive Care</keyword>
  <keyword>Individualised Care</keyword>
  <keyword>Open-Loop Decision Support System</keyword>
  <keyword>Respiratory Failure</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Spontaneous breathing Tests</keyword>
  <keyword>Extubation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoventilation</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/NCT03249623
org study id: 226610
secondary id: 2017-002627-25
nct id: NCT03249623
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Patients residing in the intensive care unit typically receive mechanical ventilatory
      support. Selecting the appropriate level of mechanical ventilation is not trivial, and it has
      been shown that lung protective settings can reduce mortality in patients with lung injury.
      Despite being a life- saving therapy, duration of mechanical ventilation should be kept at a
      minimum to reduce effects of immobilization, long-term sedation, patient discomfort, risk of
      ventilator associated pneumonia, leading to decreasing mortality and economic costs etc. The
      duration of mechanical ventilation is also an important factor in weaning from ventilatory
      support, with prolonged ventilator support making the weaning process more difficult.

      The purpose of this study is to compare mechanical ventilation following advice from the
      Beacon Caresystem to that of standard care in general medical intensive care unit (ICU)
      patients, from the start of requiring invasive mechanical ventilation until successful
      extubation. The Beacon Caresystem will be compared to standard care to investigate whether
      use of the system results in similar care or reduced time for weaning from mechanical
      ventilation.
All patients admitted to the ICU with mechanical ventilation are screened for inclusion.
      Patients receiving invasive mechanical ventilation (≥ 24 h) will be considered for inclusion
      in the study on a daily basis. Patient screening will be performed by clinical researchers or
      a delegated clinician and consent/assent will be sought. Then patients will be randomised to
      the Beacon group or Standard Care group. Randomisation will be performed using sealed
      envelopes, and in blocks of patients, allowing interim analysis of results in appropriate
      steps during the study. To avoid that results are affected by patient disease type,
      randomisation will be stratified for equal distribution between randomisation groups.

      Patients will be randomly assigned to either standard care of mechanical ventilation, or to
      follow the advice of the Beacon Caresystem. The results of these two strategies will then be
      compared based upon the following outcome measurements.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: After randomisation, for patients randomised in the Beacon group, the Beacon system will actively advice clinicians on ventilatory settings to adapt the ventilator to patient's individual clinical situation and corresponding clinical intervention.
primary purpose: Treatment
masking: Single (Participant)
measure: Length of mechanical ventilation
time frame: Daily assessment of requirement of mechanical ventilation from the time of randomisation until the date of liberation from mechanical ventilation, up to 12 months.
description: Length of mechanical ventilation, defined as either the time of intubation in the ICU, or the time of admission to the ICU following previous intubation for surgery, and until successful extubation, with successful
measure: Time to spontaneous ventilation
time frame: Daily assessment of spontaneous ventilation from the date of randomisation until the date the patient starts breathing spontaneously, up to 12 months.
description: It is defined as the time taken to wean from mandatory mode of ventilation
measure: Time to extubation
time frame: Daily assessment of time to extubation from the date of initiation of spontaneous ventilation until the date of liberation from mechanical ventilation, up to 12 months.
description: It is defined as the time the decision is made to proceed with removal of the endotracheal tube or tracheal decannulation.
arm group label: Beacon Caresystem
arm group type: Experimental
description: On randomisation to the Beacon group, a Beacon Caresystem will be connected to the patient. This involves connecting a pulse oximeter to the patient's finger (toe or ear) to measure pulse oximetry oxygen saturation and pulse, and placing a standard clinical respiratory gas analysis and flow sensor in the respiratory tubing connecting the ventilator to the patient. This sensor allows measurement of respiratory pressure, flow and volume; plus respiratory gas CO2 and O2.
arm group label: Standard Care
arm group type: No Intervention
description: For this group mechanical ventilation is managed according to standard care. A Beacon CareSystem will be connected to the patient, as for the Beacon Randomisation group, but the system will be used solely for data collection, and advice will be disabled. Physiological variables captured in this arm of the study will mirror the intervention arm. Decision relating to weaning, extubation, reintubation and sedation including level of seniority of personnel involved in the decision tree process will be documented accordingly.
intervention type: Device
intervention name: Beacon Caresystem
description: The core of the system is a set of physiological models including pulmonary gas exchange, acid-base chemistry, lung mechanics, and respiratory drive. The Beacon Caresystem tunes these models to the individual patient such that they describe accurately current measurements. Once tuned, the models are used by the system to simulate the effects of changing ventilator settings. The results of these simulations are then used calculate the clinical benefit of changing ventilator settings by balancing the competing goals of mechanical ventilation.
arm group label: Beacon Caresystem
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcela P Vizcaychipi, MD PhD FFICM
role: Principal Investigator
affiliation: Chelsea and Westminster NHS Foundation Trust
last name: Damon P Foster
phone: +44 2033156887
phone ext: 56887
email: essam.ramhamadany@chelwest.nhs.uk
last name: Stephen Rees, PhD
phone: +45 30328469
email: sr@hst.aau.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
url: http://www.chelwest.nhs.uk
description: Sponsor website
citation: Rees SE, Karbing DS. Determining the appropriate model complexity for patient-specific advice on mechanical ventilation. Biomed Tech (Berl). 2017 Apr 1;62(2):183-198. doi: 10.1515/bmt-2016-0061.
PMID: 27930361
citation: Rees SE, Karbing DS. Model-based advice for mechanical ventilation: From research (INVENT) to product (Beacon Caresystem). Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:5331-4. doi: 10.1109/EMBC.2015.7319595.
PMID: 26737495
citation: Weinreich UM, Thomsen LP, Rees SE, Rasmussen BS. The effects of oxygen induced pulmonary vasoconstriction on bedside measurement of pulmonary gas exchange. J Clin Monit Comput. 2016 Apr;30(2):207-14. doi: 10.1007/s10877-015-9703-x. Epub 2015 May 12.
PMID: 25962614
responsible party type: Sponsor
mesh term: Hypoventilation
sharing ipd: No