S4 :Trial Of Fully Closed-Loop Ventilation In ICU.

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

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-01-30

Brief Summary

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Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to extubation or death in ICU patients requiring mechanical ventilation measuring duration of mechanical ventilation in order to design a multicenter large trial.

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Detailed Description

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Conditions

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Intensive Care Patients Invasively Ventilated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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FULLY CLOSED-LOOP VENTILATION

IntelliVent-ASV automatic mode

Group Type EXPERIMENTAL

INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION

Intervention Type DEVICE

Conventional modes ventilation

Conventional modes

Group Type ACTIVE_COMPARATOR

Conventionals Modes

Intervention Type DEVICE

Interventions

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INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION

Intervention Type DEVICE

Conventionals Modes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours.

Exclusion Criteria

* broncho-pleural fistula
* dyshemoglobulinémia
* moribund patient
* do-not-resuscitate order
* chronic respiratory failure requiring long term ventilation,
* patient ventilated more than 24 hours before admission,
* pregnancy,
* age below 18 years,
* protected patients,
* patient already participating in the study,
* Cheynes-Stockes breathing.
* Included patients with a treatment withdrawal decision within 24 hours after inclusion will be excluded,
* patients transferred to another ICU,
* patients needing ECMO, patients randomized to IntelliVent having less than 20% of time in IntelliVent-ASV.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No