TerminatedPhase 4

Comparison of Extubation Delay After Prolonged Sedation

Stopped: COVID epidemic and sedation practices that have completely changed: the standard sedative is now propofol rather than midazolam.

France1 participantsStarted 2020-12-15

Plain-language summary

This monocentric, prospective, controlled, randomized, single-blind study will be conducted in surgical resuscitation at the Rouen University Hospital. The aim of our research project is to evaluate the extubation time after sedation with inhaled isoflurane compared to conventional intravenous sedation with midazolam, in patients who require prolonged sedation (3 to 28 days) in a context of septic shock. This population is particularly at risk of hypnotic accumulation due to the prolonged duration of use and the increased risk of developing renal or hepatic impairment in connection with septic shock. Based on data from the literature on shorter durations of up to 96 hours of sedation, the investigators expect a decrease in the time to extubation in patients sedated with isoflurane as well as a better quality of awakening with a decrease in resuscitation delirium. This shortened duration of mechanical ventilation could have beneficial effects on the morbidity associated with prolonged sedation and ventilation: reduction of pneumopathies acquired under mechanical ventilation, reduction of the length of stay in resuscitation and hospitalization.

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: * Major patients, * Sedated with midazolam and sufentanil for a maximum of 3 days and ventilated invasively, * Presenting a duration of sedation and invasive ventilation expected after inclusion between 3 days and 10 days, * Presenting septic shock according to the SEPSIS-3 definition with the following 4 criteria : * Clinical suspicion of infection or positive microbiological sample if applicable, * Organ Failure: SOFA (Sepsis-related Organ Failure Assessment) ≥ 2 (Annex n°5), * Need for vasoactive amines to maintain sufficient organ perfusion pressure, * Arterial lactate \> 2mmol/l, * Stabilized septic shock without the need to increase noradrenaline doses over the last 6 hours, * For women, absence of current pregnancy: negative pregnancy test, * Subjects affiliated to a social security system. * If the patient is unable to sign the consent (emergency situation) the consent will be signed by his or her representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned). In this case, the patient will subsequently be asked for consent to continue the study. Exclusion Criteria: * Refusal of the patient to continue the study after waking up, * Duration of sedation after randomization less than 3 days or more than 10 days.

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.

1This trial was terminated early — can you find out why it was stopped, and whether that affects the reliability of any data that was collected so far?
2Since this study was specifically looking at how long it takes to remove the breathing tube after stopping sedation in septic shock patients, how does understanding that timeline actually change how my care would be managed in the ICU?
3This was a Phase 4 trial, meaning the sedation medications involved were already approved — so what does it mean for my safety that the trial didn't finish, and are those sedation approaches still being used in standard care?
4Given that this trial is no longer recruiting, are there other active studies or updated protocols at this hospital that are looking at sedation and ventilator weaning in septic shock that might be relevant to my situation?
5If the goal was to reduce the delay between stopping sedation and removing the breathing tube, what approach would you use for me right now based on current evidence, since this trial didn't reach its conclusion?

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

The delay between the first sedation stop and extubation

Timeframe: 10 days

Trial details

NCT IDNCT04710914

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-26

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