Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Acute Mechanical Ventilatory Failure Psychosis Associated With Intensive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Intellivent-ASV

Patients will receive Intellivent-ASV ventilation during 12 hours

Group Type EXPERIMENTAL

Intellivent-ASV

Intervention Type DEVICE

12 hours of mechanical ventilation with intellivent-ASV

Conventional ventilation

Patients will receive pressure support ventilation during 12 hours

Group Type ACTIVE_COMPARATOR

Conventional ventilation

Intervention Type DEVICE

12 hours of mechanical ventilation with pressure support ventilation

Interventions

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Intellivent-ASV

12 hours of mechanical ventilation with intellivent-ASV

Intervention Type DEVICE

Conventional ventilation

12 hours of mechanical ventilation with pressure support ventilation

Intervention Type DEVICE

Other Intervention Names

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closed-loop ventilation pressure support ventilation

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

94 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No