Clinical trial NCT02889055: Evaluation of Mirus™ for Sedation in Resuscitation
Official title: Evaluation of Mirus™ for Sedation in Resuscitation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patient Requiring Mechanical Ventilation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient requiring mechanical ventilation for more than 48 hours

Brief summary: Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the lightest possible sedation strategies, avoiding the administration of benzodiazepines source of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion. Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane) in resuscitation is interesting because their favorable pharmacokinetic even after prolonged administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome.

There are two suitable delivery devices sevoflurane in intensive care, both with CE marking. The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use and reliable. The objective of this study was to evaluate the use of Mirus ™ device in trauma resuscitation and cardiovascular resuscitation.

Specifically, it will use this modality in case of failure with conventional sedation products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to severe agitation.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years
* In mechanical ventilation for more than 48 hours
* No intracranial hypertension
* In severe state of agitation measured by a sedation scale score greater than 2 RASS
* Agitation observed in two circumstances: receiving maximal doses of propofol (≥ 5 mg / kg / h) and / or midazolam (≥ 0.2 mg / kg / h), or weaning failure to stop the sedation agitation.

Exclusion Criteria:

* Presence of a severe head injury (Glasgow initial score between 3 and 8) requiring monitoring intracranial pressure and / or treatment of intracranial hypertension
* Sedation with dexmedetomidine
* Personal or family antecedent of anesthetic malignant hyperthermia
* Pregnant woman

Primary outcomes:
measure: ead-time (in minutes) of sevoflurane sedation for obtaining a target RASS score between 1 (anxious) and 2 (mild sedation).
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-François PAYEN, MD
role: PRINCIPAL_INVESTIGATOR
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