Respiration, Artificial
Conditions
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.
Interventions
DEVICEopen loop weaning group (Beacon)
mechanical ventilation following advice from the Beacon Caresystem
OTHERRoutine care
Standardized routine care
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation | 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 | 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 | 14 days | the time after point of randomization, from initiation of support modes of ventilation and until successful extubation |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORElie ZOGHEIB, PhD
CHU Amiens
Outcome results
None listed