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 range18 Years

SexALL

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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.

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