Clinical trial NCT02095496: Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders
Official title: Contribution to the Understanding of the Involvement of Mechanical Ventilation in ICU Patients Sleep Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Mechanical Ventilatory Failure
Psychosis Associated With Intensive Care
Keywords: sleep
intensive care
mechanical ventilation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep fragmentation index
timeFrame: 12 hours
Secondary outcomes:
measure: duration of sleep episodes
timeFrame: 12 hours
measure: Distribution of the sleep
timeFrame: 12 hours
Other outcomes:
measure: Sleep's architecture
timeFrame: 12 hours
measure: ventilation
timeFrame: 12 hours
measure: circadian rhythm
timeFrame: 6 hours
Locations:
city: Brussels
country: Belgium
facility: Intensive Care Unit, Saint Luc university Hospital
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Emilie Bialais, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: