CompletedPhase 3

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

France, Italy60 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numbers of manual adjustments

Timeframe: participants are followed until they no longer need ventilation, up to 10 days

Trial details

NCT IDNCT01781091

SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Intensive Care Patients Invasively Ventilated trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.