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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiration, Artificial

Intervention / Treatment
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* Device: open loop weaning group (Beacon)
* Other: Routine care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: open loop weaning group (Beacon)<br>mechanical ventilation following advice from the Beacon Caresystem | Device: open loop weaning group (Beacon)<br>* mechanical ventilation following advice from the Beacon Caresystem<br>|
| Active Comparator: Routine care<br>Connect and start Beacon with advice disabled Standardized routine care | Other: Routine care<br>* Standardized routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation | time from initial intubation and until successful extubation, with successful extubation defined as ≥ 7 days of unassisted spontaneous breathing after extubation. | 14 days | 
| Time to successful extubation | time from randomization and until successful extubation. | Successful extubation is defined as ≥ 7 days of unassisted spontaneous breathing after extubation | 
| Time from support mode to successful extubation | the time after point of randomization, from initiation of support modes of ventilation and until successful extubation | 14 days |