Evaluation of Mirus™ for Sedation in Resuscitation

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02889055

Acronym

MIRUS

Enrollment

Registered

2016-09-05

Start date

2016-01-17

Completion date

2016-10-08

Last updated

2018-08-21

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

Conditions

Patient Requiring Mechanical Ventilation

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.

Interventions

DEVICEpatient requiring the MIRUS (mechanical ventilation)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ead-time (in minutes) of sevoflurane sedation for obtaining a target RASS score between 1 (anxious) and 2 (mild sedation).	24 hours

Countries

France

Outcome results

None listed

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