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

Centre Hospitalier Universitaire, Amiens

Status: Unknown

Conditions: Respiration, Artificial

Treatments: Device: open loop weaning group (Beacon); Other: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT02842944

PI2016_843_0018

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

open loop weaning group (Beacon)

Experimental group

Description:

mechanical ventilation following advice from the Beacon Caresystem

Treatment:

Device: open loop weaning group (Beacon)

Routine care

Active Comparator group

Description:

* Connect and start Beacon with advice disabled * Standardized routine care

Treatment:

Other: Routine care