跳至主要内容
临床试验/NCT03818841
NCT03818841Unknown不适用

High-flow Nasal Cannula Therapy in the Treatment of Acute Carbon Monoxide Poisoning

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
96
试验地点
2
主要终点
COHb reduction at 90 minutes

研究概览

简要总结

The aim of the study is to test whether oxygen therapy delivered through high-flow nasal cannula devices in patients admitted to the emergency department for acute carbon monoxide poisoning is superior to the non-rebreathing oxygen face mask therapy with a 15 L/minute oxygen flow (currently the first-line therapy), in terms of reduction of carboxyhemoglobin (COHb) concentration and delayed neurological sequelae incidence.

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

  • Age v 18 years
  • Carbon monoxide intoxication as major problem leading to emergency department admission
  • Carboxyhemoglobin (COHb) concentration 10% at the time of enrolment

排除标准

  • Age < 18 years
  • Glasgow coma scale ≤ 13
  • Refusal to give consent

研究组 & 干预措施

Non-rebreathing oxygen mask group

Other

In this group patients will be treated with standard oxygen therapy delivered through a non-rebreathing face mask with a 15 L/min flow

干预措施: Non-rebreathing oxygen mask group (Device)

High-flow nasal cannula group

Experimental

Patients randomised in this group will receive oxygen therapy via a high-flow nasal cannula device with a 60 L/min flow and a 100% fraction of inspired oxygen

干预措施: High-flow nasal cannula device (Device)

结局指标

主要结局

COHb reduction at 90 minutes

时间窗: 90 minutes

Patients in the High-flow nasal cannula group and patients in the non-rebreathing oxygen mask group will be compared in terms of COHb reduction at 90 minutes. The hypothesis is that in patients treated with high flow nasal cannula the reduction in COHb at 90 minutes will be significantly different compared to patients treated with non-rebreathing oxygen mask.

次要结局

  • Variation in the incidence of delayed neurologic sequelae(6 weeks)
  • Variation in serum lactate concentration(6 weeks)
  • Variation in serum troponin concentration(6 weeks)
  • Variation in S100B levels concentration(6 weeks)

研究者

发起方
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验