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

Phase 3

Completed

• Conditions: Intensive Care Patients Invasively Ventilated
• Interventions: Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION; Device: Conventionals Modes

• Registration Number: NCT01781091
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Primary Completion: 2013-12
• Study Completion: 2015-01-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FULLY CLOSED-LOOP VENTILATION	INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION	IntelliVent-ASV automatic mode
Conventional modes ventilation	Conventionals Modes	Conventional modes

Primary Outcome Measures

Name	Time	Method
Numbers of manual adjustments	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 Outcome Measures

Name	Time	Method
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
Duration of invasive ventilation	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
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

Trial Locations

Locations (2)

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer; 🇫🇷 Toulon, Paca, France

Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo; 🇮🇹 Pavia, Lombardia, Italy