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TerminatedNCT02889055MIRUSUpdated Aug 21, 2018

Evaluation of Mirus™ for Sedation in Resuscitation

An observational study in Patient Requiring Mechanical Ventilation, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-21.

Sponsored by University Hospital, Grenoble · Observational

Why this study was terminated
Safety profile was not satisfying with sevolflurane
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
9
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Patient Requiring Mechanical Ventilation
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
9 participants (actual)
Patient registry
No

Interventions

  • Devicepatient requiring the MIRUS (mechanical ventilation)
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What researchers measure

Primary outcomes

  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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Study locations

1 site
  • University Hospital Grenoble
    Grenoble, 38043, France
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References and documents

Publications

  • Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72. PubMed 23269131 ↗
  • Kong KL, Willatts SM, Prys-Roberts C. Isoflurane compared with midazolam for sedation in the intensive care unit. BMJ. 1989 May 13;298(6683):1277-80. doi: 10.1136/bmj.298.6683.1277. PubMed 2500195 ↗
  • Sackey PV, Martling CR, Carlsward C, Sundin O, Radell PJ. Short- and long-term follow-up of intensive care unit patients after sedation with isoflurane and midazolam--a pilot study. Crit Care Med. 2008 Mar;36(3):801-6. doi: 10.1097/CCM.0B013E3181652FEE. PubMed 18431266 ↗
  • Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6. doi: 10.1097/01.ccm.0000145951.76082.77. PubMed 15640636 ↗
  • Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29. PubMed 21445642 ↗
  • Rohm KD, Wolf MW, Schollhorn T, Schellhaass A, Boldt J, Piper SN. Short-term sevoflurane sedation using the Anaesthetic Conserving Device after cardiothoracic surgery. Intensive Care Med. 2008 Sep;34(9):1683-9. doi: 10.1007/s00134-008-1157-x. Epub 2008 May 24. PubMed 18500419 ↗
  • Hellstrom J, Owall A, Bergstrom J, Sackey PV. Cardiac outcome after sevoflurane versus propofol sedation following coronary bypass surgery: a pilot study. Acta Anaesthesiol Scand. 2011 Apr;55(4):460-7. doi: 10.1111/j.1399-6576.2011.02405.x. Epub 2011 Feb 22. PubMed 21342154 ↗
  • Soukup J, Scharff K, Kubosch K, Pohl C, Bomplitz M, Kompardt J. State of the art: sedation concepts with volatile anesthetics in critically Ill patients. J Crit Care. 2009 Dec;24(4):535-44. doi: 10.1016/j.jcrc.2009.01.003. Epub 2009 Mar 27. PubMed 19327951 ↗
  • Perbet S, Bourdeaux D, Sautou V, Pereira B, Chabanne R, Constantin JM, Chopineau J, Bazin JE. A pharmacokinetic study of 48-hour sevoflurane inhalation using a disposable delivery system (AnaConDa(R)) in ICU patients. Minerva Anestesiol. 2014 Jun;80(6):655-65. Epub 2013 Nov 13. PubMed 24226486 ↗
  • Chabanne R, Perbet S, Futier E, Ben Said NA, Jaber S, Bazin JE, Pereira B, Constantin JM. Impact of the anesthetic conserving device on respiratory parameters and work of breathing in critically ill patients under light sedation with sevoflurane. Anesthesiology. 2014 Oct;121(4):808-16. doi: 10.1097/ALN.0000000000000394. PubMed 25111218 ↗
  • Sackey PV, Martling CR, Nise G, Radell PJ. Ambient isoflurane pollution and isoflurane consumption during intensive care unit sedation with the Anesthetic Conserving Device. Crit Care Med. 2005 Mar;33(3):585-90. doi: 10.1097/01.ccm.0000156294.92415.e2. PubMed 15753751 ↗
  • Berton J, Sargentini C, Nguyen JL, Belii A, Beydon L. AnaConDa reflection filter: bench and patient evaluation of safety and volatile anesthetic conservation. Anesth Analg. 2007 Jan;104(1):130-4. doi: 10.1213/01.ane.0000248221.44383.43. PubMed 17179257 ↗
  • Bomberg H, Glas M, Groesdonk VH, Bellgardt M, Schwarz J, Volk T, Meiser A. A novel device for target controlled administration and reflection of desflurane--the Mirus. Anaesthesia. 2014 Nov;69(11):1241-50. doi: 10.1111/anae.12798. Epub 2014 Jul 9. PubMed 25040673 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02889055
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Sep 5, 2016
Start date
Jan 17, 2016
Primary completion
Oct 8, 2016
Completion
Oct 8, 2016
Last update
Aug 21, 2018

Study contacts

Jean-François PAYEN, MD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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