Patient Requiring Mechanical Ventilation Clinical Trial
— MIRUSOfficial title:
Evaluation of Mirus™ for Sedation in Resuscitation
| Verified date | August 2018 |
| Source | University Hospital, Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 9 |
| Est. completion date | October 8, 2016 |
| Est. primary completion date | October 8, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital Grenoble | Grenoble |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ead-time (in minutes) of sevoflurane sedation for obtaining a target RASS score between 1 (anxious) and 2 (mild sedation). | 24 hours |