Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Participant recruitment
研究概览
简要总结
The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives.
The main question[s] it aims to answer are:
- Will people join the study? (recruitment)
- Will participants finish the study?
- Will healthcare teams accept the study procedures?
Participants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an open label trial that will be blinded to the outcome assessor and data analyst, but not to the clinical team. Blinding is not feasible for the clinical team and patient / family given the easily identifiable differences in the nature of the essential equipment used between the two arms.
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24 hours
- •Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible)
排除标准
- •Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas analyzer function)
- •Family history or personal history of malignant hyperthermia (MH)
- •Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas
- •Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction)
- •Moribund with expected survival < 24h
- •Known pregnancy or lactation
- •Suspected or evidence of high intracranial pressure (ICP)
- •Not a 'closed ventilator circuit' with potential for gas leak (e.g. uncuffed ETT, bronchopleural fistula, tracheal/trachea-esophageal fistulas, or other sources of "gas leak" from patient circuit that cannot be removed)
- •Prior enrollment in the ABOVE trial
研究组 & 干预措施
Inhaled sedation - volatile anesthetic
The ICU patient will receive Isoflurane. Dosage will be modified as per health care team guidance for the best treatment of the participant.
干预措施: Isoflurane Inhalant Product (Drug)
IV sedation - standard of care
The ICU patient will receive standard of care, which is IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.
结局指标
主要结局
Participant recruitment
时间窗: 2 years
Accrual and/or identification of challenges in accruing 60 mechanically ventilated participants (age 1 month to 18 years).
次要结局
- Protocol adherence(28 days)
- Attrition(3 years)
- Safety/adverse event rate(From date of consent until the date of resolution or date of death from any cause, whichever came first, assessed up to 13 months)
- Healthcare team satisfaction(Study days 1, 2 & 3)