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Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care (BEACON)

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ClinicalTrials.gov Identifier: NCT02842944
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Tracking Information
First Submitted Date  ICMJE July 21, 2016
First Posted Date  ICMJE July 25, 2016
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE December 12, 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
  • Duration of mechanical ventilation [ Time Frame: 14 days ]
    time from initial intubation and until successful extubation, with successful extubation defined as ≥ 7 days of unassisted spontaneous breathing after extubation.
  • Time to successful extubation [ Time Frame: Successful extubation is defined as ≥ 7 days of unassisted spontaneous breathing after extubation ]
    time from randomization and until successful extubation.
  • Time from support mode to successful extubation [ Time Frame: 14 days ]
    the time after point of randomization, from initiation of support modes of ventilation and until successful extubation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02842944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care
Official Title  ICMJE Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care
Brief Summary The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of routine care in patients from the state of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to routine care to investigate whether use of the system results in similar care and reduced time for weaning from mechanical ventilation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Respiration, Artificial
Intervention  ICMJE
  • Device: open loop weaning group (Beacon)
    mechanical ventilation following advice from the Beacon Caresystem
  • Other: Routine care
    Standardized routine care
Study Arms  ICMJE
  • Experimental: open loop weaning group (Beacon)
    mechanical ventilation following advice from the Beacon Caresystem
    Intervention: Device: open loop weaning group (Beacon)
  • Active Comparator: Routine care
    • Connect and start Beacon with advice disabled
    • Standardized routine care
    Intervention: Other: Routine care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2016)
116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is on invasive mechanical ventilation more 48 hours
  • Age > 18 years
  • Patients are ventilated using Maquet Servo-I, Draeger Infinity V500 or Draeger Evita XL mechanical ventilators in "pressure support", "volume controlled", or "pressure controlled" ventilation modes.
  • Haemodynamically stable (mean blood pressure ≥ 65 mmHg)
  • Patients or, in the case that the patient is unable, next of kin understand and accept oral and written information describing the study or patient consent retrospectively in case of emergency inclusion.

Exclusion Criteria:

  • The absence of an arterial catheter for blood sampling.
  • Medical history of home mechanical ventilation
  • Severe ARDS (PaO2/FiO2 ≤ 100 mmHg)
  • Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
  • Severe neurological patients (Glasgow coma score <10, neurologic damage with limited prognosis, stroke hemiplegia).
  • Known or suspected severe myopathy or neuropathy (including ICU neuromyopathy)
  • Quadriplegia
  • Severe heart failure
  • Broncho alveolar fistula with more than 100ml leakage
  • History of home mechanical ventilation
  • Pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elie ZOGHEIB, PhD +33 3 22 08 78 32 Zogheib.Elie@chu-amiens.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02842944
Other Study ID Numbers  ICMJE PI2016_843_0018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor  ICMJE Centre Hospitalier Universitaire, Amiens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elie ZOGHEIB, PhD CHU Amiens
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP