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

Intermunicipal Hospital Center Toulon

Status and phase: Completed; Phase 3

Conditions: Intensive Care Patients Invasively Ventilated

Treatments: Device: Conventionals Modes; Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION

Study type: Interventional

Funder types: Other

Identifiers

NCT01781091

CH-2012-02

2012-A1069-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

FULLY CLOSED-LOOP VENTILATION

Experimental group

Description:

IntelliVent-ASV automatic mode

Treatment:

Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION

Conventional modes ventilation

Active Comparator group

Description:

Conventional modes

Treatment:

Device: Conventionals Modes