Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Chi… (NCT04684238) | Clinical Trial Compass
CompletedPhase 3
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
France94 participantsStarted 2021-01-14
Plain-language summary
This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device (ACD)) versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.
Who can participate
Age range3 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients at least 3 years to 17 (less than 18) years at the time of randomization, admitted to an ICU/with planned ICU admission.
* Expected mechanical (invasive) ventilation and sedation for at least 12 hours.
* Informed consent obtained from the patient, patient's legal guardian(s)
Exclusion Criteria:
* Ongoing seizures requiring acute treatment.
* Continuous sedation for more than 72 hours at time of randomization.
* Less than 24 hours post cardiopulmonary resuscitation.
* Uncompensated circulatory shock.
* Known or suspected genetic susceptibility to malignant hyperthermia.
* Patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion.
* Patient with tidal volume below 30 mL or above 800 mL.
* Inability to perform reliable COMFORT-B assessment in the opinion of the Investigator
* Patients with intracranial pressure (ICP) monitoring or with suspected increase in ICP
* Patients with treatment-induced whole-body hypothermia.
* Patients with pheochromocytoma.
* Patients with prolonged QT interval or with significant risk for prolonged QT interval.
* Patient not expected to survive next 48 hours or not committed to full medical care.
What they're measuring
1
Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours)
Timeframe: Minimum of 12 hours up to 48 hours (± 6 hours).