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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

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.

Condition or disease Intervention/treatment Phase
Respiration, Artificial Device: open loop weaning group (Beacon) Other: Routine care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: open loop weaning group (Beacon)
mechanical ventilation following advice from the Beacon Caresystem
Device: open loop weaning group (Beacon)
mechanical ventilation following advice from the Beacon Caresystem

Active Comparator: Routine care
  • Connect and start Beacon with advice disabled
  • Standardized routine care
Other: Routine care
Standardized routine care




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842944


Contacts
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Contact: Elie ZOGHEIB, PhD +33 3 22 08 78 32 Zogheib.Elie@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Elie ZOGHEIB, PhD    +33 3 22 08 78 32    Zogheib.Elie@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Elie ZOGHEIB, PhD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02842944     History of Changes
Other Study ID Numbers: PI2016_843_0018
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No