跳至主要内容
临床试验/NCT06124027
NCT06124027招募中不适用

What is the Effect of Deep Procedural Sedation With HFNOT on the tcPCO2, mitoPO2 and mitoVO2.

Calvin de Wijs, MSc1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
35
试验地点
1
主要终点
tcPCO2.

研究概览

简要总结

Deep procedural sedation has seen an increased use indication over the last couple of years aided by the introduction of high flow nasal oxygen therapy (HFNOT) during these procedures. However, this level of deep sedation does come with the increased risk of examining whether a patient is adequately ventilated during this procedure.

The definition of deep sedation is: 'a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.' As the definition showed there may be an insufficient ventilation during deep sedation. Therefore, HFNOT is used to ensures that the peripheral oxygen saturation is sufficient. However, there are two potential disadvantages. HFNOT can mask the presence of an insufficient respiratory minute volume and an insufficient gas exchange, which can lead to high arterial CO2 (paCO2) levels. Another risk associated with HFNOT is the fact that high oxygen levels are toxic, and prolonged exposure to high partial oxygen pressures, can cause oxidative damage to cell membranes, collapse of the alveoli in the lungs, retinal detachment, and seizures. Most of this damage can be explained by hyperoxia that increases the 'leak' of electrons from the mitochondrial electron transport chain and the resulting increased generation of reactive oxygen species (ROS). Low paCO2 levels and hyperoxia cannot be examined using standard monitoring techniques therefore, this study will use the transcutaneous carbon dioxide (tcPCO2) a proven technique which correlates well to the arterial CO2 (paCO2) to evaluate whether there is an adequate level of ventilation during deep procedural anesthesia with HFNOT. Moreover, the cutaneous mitochondrial oxygenation (mitoPO2) will be monitored to determine the effects that deep procedural sedation with HFNOT has on the cellular oxygenation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 over 18 years
  • Acceptable proficiency of the Dutch language
  • Scheduled for a procedure requiring deep procedural sedation with HFNOT.

排除标准

  • Porphyria
  • Known intolerance to components of the ALA plaster
  • Presence of mitochondrial disease
  • Pregnancy/lactation
  • Patients with skin lesions on the measurement location which impede measurements
  • Incapability to provide inform consent, due to a mental condition interfering with the ability to understand the provided information

结局指标

主要结局

tcPCO2.

时间窗: up to 6 hours

To examine the effects of deep procedural sedation and use of HFNOT on the tcPCO2.

mitoPO2

时间窗: up to 6 hours

To determine the effects of deep procedural sedation and use of HFNOT on the mitoPO2

次要结局

  • mitoVO2(up to 6 hours)

研究者

发起方
Calvin de Wijs, MSc
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Calvin de Wijs, MSc

M.D.

Erasmus Medical Center

研究点 (1)

Loading locations...

相似试验