EUCTR2020-000578-31-DE进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •4. Germany only: Women of childbearing potential who are sexually active: The patient does already use a highly effective contraception method or agrees to use a highlyeffective contraception method from signing the informed consent form (screening) until the operation / study treatment. According to Clinical Trials Facilitation Group (CTFG) recommendations, methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- •progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- •intrauterine device
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomised partner
- •sexual abstinence or absence of sexual relations with men
- •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
排除标准
- •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.
研究者
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