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临床试验/NCT02494154
NCT02494154Unknown不适用

Effects of Treatment With High Flow Nasal Cannulas on Respiratory Pattern and Work of Breathing Among Patients.

Laval University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
16
试验地点
2
主要终点
Work of breathing

研究概览

简要总结

This study evaluates the work of breathing among patients under various conditions of treatment with high flow nasal cannulas. Sixteen spontaneously breathing patients with respiratory failure (hypercapnic or hypoxemic) will be included. The design of this study is a cross over of four treatment periods with different flow settings.

详细描述

High flow oxygen therapy (HFOT) is a promising technique increasingly used in the management of acute respiratory failure. In hospitalised hypoxemic patients, recent clinical evidence showed that HFOT can reduce endotracheal intubation and reduce mortality. Physiologically, the HFOT causes a decrease in respiratory rate and minute-ventilation and may be associated with a decrease in PaCO2. It is possible that these effects are associated with decreased work of breathing, which could explain some of the benefits in terms of comfort and efficiency.

The objective of this research is to evaluate the impact of a wash-out of anatomical dead space by high flow nasal cannulas on respiratory parameters and on the work of breathing.

The investigators will evaluate the baseline status with conventional oxygen therapy methods (low flows), and then compare it with three different levels of high flow oxygen therapy in a randomised order. The primary endpoint will be the work of breathing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

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

  • Spontaneously breathing patients exhibiting a respiratory distress defined by a respiratory rate ≥ 20 breaths/min associated with
  • either hypoxemia (SpO2<90% with O2≥3L/min) ;
  • or hypercapnia (PaCO2>45 mmHg with a respiratory acidosis (pH<7,38).

排除标准

  • Patients below 18yo, pregnant or breastfeeding women;
  • Patients enrolled in another study excluding co-enrolment;
  • History of ear nose and throat disease (i.e. surgery, epistaxis, trauma), eso-gastric disease (i.e. esophageal varices, digestive haemorrhage), rheumatologic or neurologic disease possibly interfering with the design of the study;
  • Acute respiratory or cardiovascular disease contra-indicating the enrolment in the study protocol (i.e. acute coronary syndrome, pulmonary embolism, pneumothorax);
  • Need for immediate intubation or for continuous noninvasive ventilation and/or recent (<6h) arterial blood gases showing a respiratory acidosis with a pH<7.30;
  • Patient feeling nauseous or under recent fed condition (<1h).

结局指标

主要结局

Work of breathing

时间窗: 15 minutes

Work of breathing at the end of each period is calculated from the measurement of esophageal pressure and tidal volume (composite outcome)

次要结局

  • Esophageal pressure-time product(15 minutes)
  • Comfort of breathing(15 minutes)
  • End-tidal carbon dioxide(15 minutes)
  • Blood gases(15 minutes)
  • Tidal volume(15 minutes)
  • Respiratory rate(15 minutes)
  • Dyspnea(15 minutes)
  • Heart rate(15 minutes)
  • Oxygen saturation(15 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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