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临床试验/NCT04109560
NCT04109560已完成不适用

High Flow Nasal Oxygen Therapy in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure (AHRF)

Argentinian Intensive Care Society1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年8月1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
40
试验地点
1
主要终点
Need for endotracheal intubation

研究概览

简要总结

High-flow nasal cannula (HFNC) enables delivering humidified gas at high-flow rates controlling the oxygen inspired fraction (FiO2). Its efficacy has been demonstrated in hypoxemic acute respiratory failure. However, little is known about its use in hypercapnic acute respiratory failure (ARF). Therefore, we aimed to evaluate the effect of using HFNC through "Precision Flow" equipment as first line of ventilatory support for COPD patients with hypercapnic acute respiratory failure.

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

  • Moderate to very severe COPD patients (GOLD 2 to 4) over 18 years old admitted to the ICU with hypercapnic ARF (PaCO2> 45 mmHg and respiratory acidosis [pH ≥7.30], with or without hypoxemia + one of the following: Respiratory Rate ≥25 cycles per minute, intercostal and / or supraclavicular recruitment, or thoraco-abdominal synchrony, no prior use of NIV)

排除标准

  • Patients less than 18 years old
  • Mild COPD patients
  • Absence of hypercapnia
  • Kelly M Score > 3
  • Haemodynamic instability (despite fluid resuscitation)
  • NIV or Invasive Mechanical Ventilation (IMV) (Need to use previously to HFNC)
  • Contraindications to implement high-flow oxygen therapy.

结局指标

主要结局

Need for endotracheal intubation

时间窗: From inclussion study date until the first day of endotracheal intubation documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.

The need and causes for endotracheal intubation will be recorded in the all study period.

Need for non-invasive ventilation

时间窗: From inclussion study date until the first day of noninvasive ventilation use documented, after high flow oxygen therapy use or death date from any cause, whichever came first, assessed up to 4 weeks.

The need and causes for non-invasive ventilation will be recorded in the all study period.

次要结局

  • Gas Exchange(Arterial blood gases will be recorded 1, 24 hours and every 24 hours after enrollment)
  • Patient's discomfort(Patient's discomfort will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment)
  • Respiratory variables(Respiratory variables will be recorded at 1, 2, 3, 6, 12, 24 hours and every 24 hours after enrollment)

研究者

发起方
Argentinian Intensive Care Society
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gustavo Plotnikow

Physical Therapist

Argentinian Intensive Care Society

研究点 (1)

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