Evaluation of Mirus™ for Sedation in Resuscitation (MIRUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02889055
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment
Patient Requiring Mechanical Ventilation Device: patient requiring the MIRUS (mechanical ventilation)

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Mirus™ for Sedation in Resuscitation
Study Start Date : September 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Primary Outcome Measures :
  1. ead-time (in minutes) of sevoflurane sedation for obtaining a target RASS score between 1 (anxious) and 2 (mild sedation). [ Time Frame: 24 hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient requiring mechanical ventilation for more than 48 hours

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02889055

Contact: Jean-François PAYEN, MD 04 76 76 92 88
Contact: Stéphane COMBAZ

University Hospital Grenoble Recruiting
Grenoble, France, 38043
Contact: Jean-François PAYEN, MD   
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Jean-François PAYEN, MD University Hospital, Grenoble


Responsible Party: University Hospital, Grenoble Identifier: NCT02889055     History of Changes
Other Study ID Numbers: 38RC15.111
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No