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Trial record 2 of 6 for:    sevoflurane mechanical | Recruiting, Not yet recruiting, Available Studies

Evaluation of Mirus™ for Sedation in Resuscitation (MIRUS)

This study is currently recruiting participants.
Verified April 2017 by University Hospital, Grenoble
Sponsor:
ClinicalTrials.gov Identifier:
NCT02889055
First Posted: September 5, 2016
Last Update Posted: April 5, 2017
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.
Information provided by (Responsible Party):
University Hospital, Grenoble
  Purpose

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 Intervention
Patient Requiring Mechanical Ventilation Device: patient requiring the MIRUS (mechanical ventilation)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Mirus™ for Sedation in Resuscitation

Further study details as provided by University Hospital, Grenoble:

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

Estimated Enrollment: 70
Study Start Date: September 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02889055


Contacts
Contact: Jean-François PAYEN, MD 04 76 76 92 88 JFPayen@cju-grenoble.fr
Contact: Stéphane COMBAZ SCombaz@chu-grenoble.fr

Locations
France
University Hospital Grenoble Recruiting
Grenoble, France, 38043
Contact: Jean-François PAYEN, MD       JFPayen@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-François PAYEN, MD University Hospital, Grenoble
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02889055     History of Changes
Other Study ID Numbers: 38RC15.111
First Submitted: August 3, 2016
First Posted: September 5, 2016
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No