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临床试验/NCT05958537
NCT05958537已完成不适用

Use of High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement Procedures. Impact on Respiratory Complications and Biomarkers

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
2
主要终点
The number of oxygen desaturation episodes

研究概览

简要总结

Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. The use of HFNO could be justified in this context and could improve the results and safety of these procedures. The use of HFNO during sedation for TAVR could increase oxygen content and minimise hypercapnia, which occurs frequently. This may have 2 potential benefits: one in terms of facilitating the patient's tolerance to anaesthetic sedation; and the other to optimise oxygen delivery to organs such as the brain, kidneys, and myocardium.

Primary aim The number of oxygen desaturation episodes. An oxygen desaturation episode is defined as any episode of Sp02 <93% for more than 10 seconds.

Method A single-center prospective randomised controlled clinical trial with 132 individuals comparing the use of High Flow Nasal oxygen (intervention group) with the conventional standard of care oxygenation with nasal cannula standard oxygenation (control group) of patients undergoing sedation for transfemoral TAVR. The randomisation process will be carried out with a 1:1 assignment, using the RedCap Clínic tool for this purpose. Both groups will be treated at the same centre and by the same interventional cardiology and anaesthesia team. Sedation regime will be based on Target controlled infusion (TCI) with propofol and remifentanil. Local anaesthesia will be infiltrated by interventional cardiologist prior obtaining femoral vascular access. 50 L/min with 0.6% FiO2 will be administered through a high-flow nasal cannula in the intervention group. In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients >18 years of age undergoing transfemoral TAVR procedure under local anaesthesia and sedation consenting to participate in the study

排除标准

  • <18 years and/or refusal to give informed consent for participation General anaesthesia required to perform complex cases of TAVR

结局指标

主要结局

The number of oxygen desaturation episodes

时间窗: up to 24 hours

An oxygen desaturation episode is defined as any episode of Sp02 \<93% more than 10 seconds

The number of patients with at least 1 desaturation episode

时间窗: up to 24 hours

An oxygen desaturation episode is defined as any episode of Sp02 \<93% more than 10 seconds

次要结局

  • Hypoxia(At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation)
  • Trends in plasmatic Biomarkers of myocardial injury(the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.)
  • Hipercapnia(At placing the arterial catheter moment (baseline), and 45 minutes after the start of sedation)
  • Trends in plasmatic enolase neurospecific(the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.)
  • Respiratory depression(During the TAVI procedure)
  • Trends in plasmatic Biomarkers of kidney injury(the day before the procedure (baseline), 45 minutes, and 8 hours after the start of sedation.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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