Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contribution to the Understanding of the Involvement of Mechanical Ventilation in ICU Patients Sleep Disorders

Conditions
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Acute Mechanical Ventilatory Failure, Psychosis Associated With Intensive Care

Intervention / Treatment
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* Device: Intellivent-ASV
* Device: Conventional ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 94 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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intellivent-ASV<br>Patients will receive Intellivent-ASV ventilation during 12 hours | Device: Intellivent-ASV<br>* 12 hours of mechanical ventilation with intellivent-ASV<br>* Other names: closed-loop ventilation;|
| Active Comparator: Conventional ventilation<br>Patients will receive pressure support ventilation during 12 hours | Device: Conventional ventilation<br>* 12 hours of mechanical ventilation with pressure support ventilation<br>* Other names: pressure support ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep fragmentation index | = number of awakenings and arousals per hour of sleep | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of sleep episodes |  | 12 hours | 
| Distribution of the sleep | distribution of the sleep during day and night | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, intensive care, mechanical ventilation