Evaluation of Mirus™ for Sedation in Resuscitation

Terminated

• Conditions: Patient Requiring Mechanical Ventilation

• Registration Number: NCT02889055
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-17
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Primary Completion: 2016-10-08
• Study Completion: 2016-10-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France