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Clinical Trials/EUCTR2020-000578-31-SE
EUCTR2020-000578-31-SEActive, not recruitingPhase 1

A Randomised Active-controlled Study to Compare Efficacy and Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) to Intravenous Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years Old - IsoCOMFORT study

Sedana Medical AB0 sites100 target enrollmentStarted: June 30, 2020Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
100
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Paediatric patients at least 3 years to 17 (less than 18, patients who
  • •will turn 18 years during the study [including follow-up] will not be
  • •included) years at the time of randomisation, admitted to an ICU/with
  • •planned ICU admission.
  • •2. Expected mechanical (invasive) ventilation and sedation for at least 12 hours.
  • •3. Informed consent obtained from the patient, patient’s legal guardian(s) as required
  • •by local regulations. Where applicable, assent obtained from the patient to participate in the clinical study.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 100
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range 0
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

  • •1. Ongoing seizures requiring acute treatment.
  • •2. Continuous sedation for more than 72 hours at time of randomisation.
  • •3. Less than 24 hours post cardiopulmonary resuscitation.
  • •4. Uncompensated circulatory shock.
  • •5. Known hypersensitivity to isoflurane or to other halogenated anaesthetics (such as
  • •halothane), benzodiazepines, non-investigational medicinal product(s) (analgesics, additional rescue sedatives that may be required during the study) or to any of their formulation ingredients.
  • •6. Known or suspected genetic susceptibility to malignant hyperthermia.
  • •7. Patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion.
  • •8. Patient with tidal volumes below 30 mL or above 800 mL.
  • •9. Inability to perform reliable COMFORT-B assessment in the opinion of the Investigator e.g. due to (not limited to):
  • •Severe traumatic brain injury, intracranial pathology (tumour, haemorrhage, infections), with a profound effect on the level of consciousness, severe mental retardation, major congenital anomalies of the central nervous system, severe myasthenia gravis, spinal muscular atrophy, or other severe neurologic disease, ongoing neuromuscular blockade which precludes COMFORT-B scoring.
  • •10. Patients with intracranial pressure (ICP) monitoring or with suspected increase in ICP
  • •11. Patients with treatment-induced whole-body hypothermia.
  • •12. Patients with pheochromocytoma.
  • •13. Patients with prolonged QT interval or with significant risk for prolonged QT interval.
  • •14. Patient not expected to survive next 48 hours or not committed to full medical care.
  • •15. Female patients who are pregnant or breast-feeding.
  • •16. Previous participation in the study (a patient can only participate once).
  • •17. Known participation in any other clinical study that included drug treatment within three months of the first administration of the IMP.
  • •18. Any for the study relevant medical history, or ongoing clinically significant disease, disorder or laboratory result which, in the opinion of the Investigator, precludes participation in the study for medical or ethical reasons.

Investigators

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