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OpenTrials
Completed

NCT Number: NCT02842944

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

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.

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Key information

Conditions

Respiration, Artificial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

open loop weaning group (Beacon)

Device

mechanical ventilation following advice from the Beacon Caresystem

Routine care

Other

Standardized routine care

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: BEACON

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2016
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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