Effect of the Adjunction of the Double Trunk Mask Above Standard Nasal Cannula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Oxygenation
研究概览
简要总结
The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with severe hypoxia.
详细描述
This is a single-center, randomized, blind investigator, 2-way crossover study design. Enrolled participants had hypoxia being treated at Intensive Care Unit associated with a hospital in Hornu (Epicura).
The study consisted of two intervention periods separated by a washout period of 30 minutes.
The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with hypoxia.
The protocol and informed consent documents were reviewed and approved by a recognized ethics review board at the study facility. The study was performed in accordance with the Declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Regardless of gender, at least 18 years of age and diagnosed with Hypoxia (PaO2/FiO2 < 380 mm Hg), dyspnea, respiratory rate (RR) ≥ 25 CPM, PaCO2 ≤ 45 mmHg, patient with an arterial catheter and without hemodynamic instability, Glasgow Coma Scale ≥ 12/15, written consent. Participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel.
排除标准
- •Patients were excluded if they Hypercapnia (> 45 mm Hg with respiratory acidosis), COPD, pulmonary fibrosis, hypoventilation obesity syndrome, arterial pressure < 60 mm Hg or treatment by epinephrine > to 0,1 gamma/kg/minute, deterioration of awareness (Glasgow scale < or = 12), acute confusional state.
- •Participants were randomized in a 1:1 ratio to receive either classical oxygenation with nasal cannula (NC) for 20 minutes or NC with an adjunctive of a Double Trunk Mask.
研究组 & 干预措施
Double Trunk Mask
DTM will be add above nasal cannula
干预措施: DTM will be add above NC (Device)
Nasal Cannula Alone
Patients receive oxygen only thought nasal Cannula
干预措施: DTM will be add above NC (Device)
结局指标
主要结局
Oxygenation
时间窗: 30 minutes
we will observe effect of adjunction of a DTM on PaO2
次要结局
- PaCO2(30 minutes)
研究者
frédéric Duprez
EPICURA ICU Hornu
Laboratory of Movement, Condorcet, Tournai, Belgium