Status:
COMPLETED
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
Lead Sponsor:
Sedana Medical
Conditions:
Sedation
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief 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 ventila...
Detailed Description
This is a phase III, multi-centre, prospective, randomized, active-controlled, assessor-blind study. Primary endpoint: percentage of time of adequately maintained sedation, in absence of rescue sedati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2023
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04684238
Start Date
January 14 2021
End Date
January 19 2023
Last Update
May 25 2025
Active Locations (24)
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1
Hôpital Femme-Mère-Enfant Groupe Hospitalier Est
Lyon, France
2
CHU de NANTES, Hôpital Mère-Enfant
Nantes, France
3
Hôpital Robert-Debré AP-HP
Paris, France
4
Hôpitaux Universitaires Paris Sud Site Bicetre
Paris, France