NCT04684238CompletedPhase 3
A Randomised Active-controlled Study to Compare Efficacy & Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) vs IV Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3-17 Years Old
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sedana Medical
- Enrollment
- 94
- Locations
- 24
- Primary Endpoint
- Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours)
Study Overview
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 ventilated children admitted to an intensive care unit.
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 sedation, within the COMFORT-B interval (light, moderate, or deep sedation) prescribed at randomization, monitored every 2 hours for an expected minimum of 12 hours (up to 48 hours).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Drug: Midazolam
Active Comparator
Midazolam for sedation in the ICU
Intervention: Midazolam (Drug)
Drug: Isoflurane
Experimental
Volatile for sedation in the ICU
Intervention: Isoflurane (Drug)
Outcomes
Primary Outcomes
Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours)
Time Frame: Minimum of 12 hours up to 48 hours (± 6 hours).
Percentage of time of adequately maintained sedation within the COMFORT-B interval (light, moderate or deep sedation) prescribed at randomisation, monitored every 2 h for a minimum of 12 h (up to 48 h ± 6 h)
Secondary Outcomes
- Compare Ventilator-free Days(From start of study treatment up to 30 days)
- Evaluate the Frequency of Delirium(Patients admitted to the ICU ≥48 hours (including period prior to study enrolment) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first.)
- Compare the Use of Opioids(Last 4 hours of study treatment compared to first 4 hours of study treatment after first blinded COMFORT-B assessment (at +2 h from start of study drug initiation).)
- Compare Time From End of Study Drug Administration to Extubation(From end of study drug administration to extubation or end of extubation attempt)
- Compare the Proportion of Time With Spontaneous Breathing(From initiation of study drug treatment to End of study treatment (up to 48h +/- 6h))
- Evaluate Haemodynamic Effect as Indicated by Need for Additional Inotropic/Vasopressor Agent(From start of study treatment to end of study treatment (up to 48h +/- 6h))
- Evaluate the Number of Patients With Withdrawal Symptom(From > 96 hours sedation (including pre-study sedation period) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first.)
- Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction(During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam)
- Compare the 30 Days/Hospital Mortality(From start of study treatment up to 30 days)
- Compare the Time in ICU/Hospital(From start of study treatment up to 30 days)
- Compare ICU-free Days(From start of study treatment up to 30 days)
Investigators
Study Sites (24)
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