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临床试验/NCT04383821
NCT04383821已完成不适用

Comparison of the Effects of Two Oxygen Delivery Systems on Arterial Blood Gases: Non-rebreather Mask Versus Double-trunk Mask

Cliniques universitaires Saint-Luc- Université Catholique de Louvain4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
4
主要终点
Changes in PaO2

研究概览

简要总结

This study will compare the impact of the Double-Trunk Mask (DTM) with the Non-Rebreather Mask (NRM) on the blood gases of patients with severe hypoxemia.

详细描述

The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.

Each included patient will wear the standard Non-Rebreather Mask (NRM) which is the standard delivery oxygen system for patients with acute severe hypoxemia. Then the patients will wear the DTM for 30 minutes. Finally the DTM will be replaced by the NRM for the next 30 minutes. The impact of both oxygen delivery system will be assessed by measuring the change of blood gases with each system.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
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

  • Acute hypoxemia not corrected with nasal cannula

排除标准

  • Chronic obstructive pulmonary disease or other chronic respiratory disease with hypercapnia
  • Confusion
  • Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

结局指标

主要结局

Changes in PaO2

时间窗: At baseline and 30 minutes after wearing DTM

Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system

次要结局

  • Dyspnea with the oxygen delivery systems(30 minutes after wearing both systems)
  • Changes in PaCO2(At baseline and 30 minutes after wearing DTM)
  • Changes in respiratory rate(At baseline and 30 minutes after wearing both systems)
  • Changes in pH(At baseline and 30 minutes after wearing DTM)
  • Comfort with the oxygen delivery systems(30 minutes after wearing both systems)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Principal Investigator
主要研究者

William Poncin, PT, PhD

Principal Investigator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

研究点 (4)

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