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

S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01781091

Acronym

Enrollment

Registered

2013-01-31

Start date

2012-12-31

Completion date

2015-01-30

Last updated

2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Patients Invasively Ventilated

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.

Interventions

DEVICEINTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION

DEVICEConventionals Modes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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
sedation duration,	participants are followed until they no longer need ventilation, up to 10 days
ICU Mortality	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

Countries

France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026