Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 6
- 主要终点
- Proportion of patients progressing to NIV in each cohort
研究概览
简要总结
Current evidence suggests a mechanistic and physiological rationale for the use of high flow nasal cannula (HFNC) in acute respiratory hypoxemic failure (AHRF) based on physiological studies in airway models, healthy volunteers and patients with Chronic Obstructive Respiratory Disease (COPD). This is supported by observational studies in patients with AHRF with reductions in a range of respiratory and other physiological parameters. Observational studies also suggest similar intubation rates and lower failure rates with HFNC when compared to non-invasive ventilation (NIV) with improved patient acceptance and tolerance for HFNC.
The role of HFNC is less clear in acute hypercapnic respiratory failure. Although non-invasive ventilation is the recommended treatment, it is associated with discomfort, and a significant proportion (up to 25% in some reports) cannot tolerate non-invasive ventilation. Observational reports and limited data from randomized controlled trials suggests that HFNC is effective in treating patients with hypercapnic respiratory failure.
We designed this trial to assess whether early application of HFNC in patients with non-severe hypercapnic respiratory failure can correct barometric abnormalities, and prevent progression to non-invasive ventilation or tracheal intubation and mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, nor the participants, nor the treating physicians, nor the investigator can be blinded. However, the outcomes will be analyzed an independent statistician blinded to the treatment assignments.
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
- •Adult patients > 18 years of age
- •Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 45 mmHg
排除标准
- •Pregnant or Breast-Feeding
- •Patients who cannot read and understand French or English
- •Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
- •Hypercapnia secondary to exacerbation of asthma
- •Contraindication to NIV
- •Contraindication to HFNC
- •Not for escalation to NIV based on a ceiling of care
- •pH < 7.15
- •GCS 8 or less
- •Shock defined as systolic < 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation
- •Respiratory or cardio-respiratory arrest
- •Any other indication that requires immediate invasive/non-invasive mechanical ventilation
结局指标
主要结局
Proportion of patients progressing to NIV in each cohort
时间窗: 6 hours
次要结局
- Mean arterial pressure(1 hour, 6 hours, 24 hours, and daily until study completion)
- Admission to the intensive care unit(Up to 90 days after enrolment, or until hospital discharge)
- Intensive care unit length of stay(Up to 90 days after enrolment, or until discharge from the intensive care unit)
- Hospital length of stay(Up to 90 days after enrolment, or until hospital discharge)
- Respiratory rate(1 hour, 6 hours, 24 hours, and daily until study completion)
- In-hospital mortality(Up to 90 days after enrolment, or until hospital discharge)
- Venous blood gas PCO2(1 hour, 6 hours, and 24 hours)
- Heart rate(1 hour, 6 hours, 24 hours, and daily until study completion)
- Patient comfort(1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days)
- Venous blood gas pH(1 hour, 6 hours, and 24 hours)
- Incidence of intubation(Up to 90 days after enrolment, or until hospital discharge)
- Shortness of breath(1 hour, 6 hours, 24 hours, and daily until cessation of oxygen therapy, up to a maximum of 7 days)