NCT01781091
Completed
Phase 3
S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer2 sites in 2 countries60 target enrollmentDecember 2012
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Intensive Care Patients Invasively Ventilated
- Sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Numbers of manual adjustments
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Numbers of manual adjustments
Time Frame: participants are followed until they no longer need ventilation, up to 10 days
Numbers of manual adjustments of the FULLY CLOSED-LOOP VENTILATION device ( INTELLIVENT ASV)
Secondary Outcomes
- ICU Mortality(participants are followed until they no longer need ventilation, up to 10 days)
- sedation duration,(participants are followed until they no longer need ventilation, up to 10 days)
- 28 days mortality(participants are followed until they no longer need ventilation, up to 10 days)
- Duration of invasive ventilation(participants are followed until they no longer need ventilation, up to 10 days)
- ventilation parameters(participants are followed until they no longer need ventilation, up to 10 days)
- Sedation doses(participants are followed until they no longer need ventilation, up to 10 days)
Study Sites (2)
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