ACTRN12622001264774招募中未知
A pilot study to investigate the safety and tolerability of warm and humidified carbon dioxide delivery to the surgical site in patients undergoing craniotomy.
Fisher and Paykel Healthcare pty ltd0 个研究点目标入组 30 人开始时间: 2022年9月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Patients aged between 18-80 years.
- •Undergoing elective craniotomy for an aneurysm clipping through a Pterional approach, performed by a participating surgeon.
- •Has had adequate time to consider their participation in the study and discuss it with family and friends, and have their questions answered by a member of the study team.
- •Understands the risks and benefits of the study, and able to provide written informed consent.
排除标准
- •Previous pterional craniotomy on the same side as the proposed procedure. i.e left or right-hand side.
- •Patients with a known sensitivity to carbon dioxide
- •Patients who are being treated for emergency or acute procedures.
- •Patients with aneurysms classified as giant (larger than 25mm in diameter). Larger aneurysms result in a greater risk to the patient and may result in a more complex operation. Due to the main outcome of this study being safety minimizing the risk / complexity associated with procedure alone is preferential.
- •Patients with active medical or psychiatric conditions or participation in another clinical trial which, in the opinion of the PI / operating surgeon, would compromise (or interfere with) their ability to participate in the study, or means that it would not be in their best interest to participate.
研究者
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