Acute Mechanical Ventilatory Failure, Psychosis Associated With Intensive Care
Conditions
Keywords
sleep, intensive care, mechanical ventilation
Brief summary
Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known factor in this deterioration.The investigators hypothesize that close-loop ventilation mode (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the patient needs.
Detailed description
In intensive care, conventional mechanical ventilation (pressure support) generates apneas and asynchronies during sleep. Intellivent-ASV would be able to avoid apneas, providing controlled cycles when respiratory rate become too low. Moreover, the constant adjustment of ventilatory parameters to the patient needs would avoid asynchronies between the ventilator and the patient ventilatory drive.
Interventions
DEVICEIntellivent-ASV
12 hours of mechanical ventilation with intellivent-ASV
DEVICEConventional ventilation
12 hours of mechanical ventilation with pressure support ventilation
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 94 Years
Healthy volunteers
No
Inclusion criteria
* patient under invasive mechanical ventilation since at least 6 hours and for expected at least 48 hours duration, including a continuous period of 24h, from 2 p.m. to 2 p.m. the next day. * Age \> 18 years * Body Mass Index \< 40 * informed consent signed by the family
Exclusion criteria
* patient requiring neuo-muscular blocking agent or deep sedation enough to abolish spontaneous ventilatory effort * patient with encephalopathy regardless of origin * Patient with Glasgow coma scale score \< 8 * Patient abusing of drug or alcohol * patient with a contraindication for placement of a nasogastric tube such that sufferers of esophageal or gastric ulcer, tumors, diverticulitis or bleeding varices or patients with sinusitis epistaxis or having recently been operated on the nose or pharynx * Patient with bleeding disorders * Patient with unstable respiratory situation as defined by a arterial oxygen partial pressure and inspired oxygen fraction ratio (PaO2/FiO2) \< 100 mmHg with positive end expiratory pressure (PEEP) \> 12 cmH2O * Patient with unstable hemodynamic situation as defined by Systolic Blood Pressure (SBP) \< 75 mmHg despite a therapeutic optimization * Inclusion in another research protocol submitted to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep fragmentation index | 12 hours | = number of awakenings and arousals per hour of sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of sleep episodes | 12 hours | — |
| Distribution of the sleep | 12 hours | distribution of the sleep during day and night |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep's architecture | 12 hours | proportion of the different phases of sleep (slow waves sleep stage 1, 2, 3 and 4 and Rapid Eye Movement (REM) sleep) |
| ventilation | 12 hours | number of asynchronies and apneas and ventilatory variability |
| circadian rhythm | 6 hours | Plasmatic melatonin dosage |
Countries
Belgium
Outcome results
None listed