Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,084
- 试验地点
- 29
- 主要终点
- Mortality
研究概览
简要总结
De novo hypoxemic acute respiratory failure (hARF) is one of the main causes of intensive care unit (ICU) admission. In de novo hARF, intubation is associated with a dramatic increase in mortality rate. Compared to standard oxygen, the use of high-flow oxygen nasal cannula (HFNC) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. Even with HFNC, the intubation rate remains high. This is the reason why adjunctive therapies, administered in addition to HFNC are needed.
Continuous positive airway pressure (CPAP) is one of these adjunctive therapies. CPAP provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. In addition, as opposed to pressure support, CPAP is well tolerated during long periods of time. Therefore, applying CPAP in addition to HFNC may reduce intubation rate and in turn mortality rate.
The present trial will evaluate the impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a Prospective, Randomized Controlled Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Adults (≥ 18 years old)
- •Admitted in the ICU for ≤ 24 hours
- •De novo hARF defined by the three following criteria:
- •Respiratory rate > 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration
- •PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered.
- •Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan
- •Informed consent from the patient or her/his next of kin or another substitute decision maker, or inclusion procedure in emergency if the patient is unable to consent
排除标准
- •Refusal of study participation by the patient or the proxy
- •Anatomical factors precluding the use of a nasal cannula or CPAP
- •Long term oxygen
- •Home CPAP or NIV or CPAP or NIV initiated prior to ICU admission
- •Hypercapnia indicating NIV (PaCO2 > 45 mmHg)
- •Isolated cardiogenic pulmonary oedema indicating NIV
- •Known pregnancy or breastfeeding
- •Absence of coverage by the French statutory health care insurance system (including AME)
- •Abdominal, thoracic or cardiac surgery within the last 6 days
- •Use of vasopressors (norepinephrine>0.3 mcg/kg/min)
- •Glasgow coma scale < 13
- •Urgent need for endotracheal intubation
- •Patients at an end-of-life stage receiving compational oxygenation
- •Exacerbation of a chronic respiratory disease
- •Legal protection (curatorship or tutorship)
- •Undrained pneumothorax
研究组 & 干预措施
HFNC
Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization.
干预措施: HFNC (Other)
HFNC with CPAP
Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions
干预措施: HFNC (Other)
HFNC with CPAP
Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions
干预措施: CPAP and HFNC (Other)
结局指标
主要结局
Mortality
时间窗: 90 days
Time to death within the 90 days after randomization
次要结局
- Death within the ICU(through patient participation period,180 days maximum)
- Time to death(through patient participation period, an average of 180 days maximum)
- Number of HFNC-free days at 28 days defined as days non-intubated, alive and without HFNC.(Between day 1 and day 28.)
- ICU length of stay.(through patient participation period,180 days maximum)
- Occurrence of any adverse event during the ICU stay, with a particular focus on hospital or ventilator associated pneumonia, non-respiratory infections, cardiac arrhythmia, and cardiac arrest.(through patient participation period,180 days maximum)
- Intensity of dyspnea until intubation as assessed by a visual analogic scale from zero (no dyspnea) to 100 (maximum possible dyspnea).(2, 6, 12 and 24 hours)
- Respiratory rate(6, 12 and 24 hours)
- Evaluation of intolerance to oxygenation technique until intubation(12 and 24 hours)
- Number of invasive ventilation-free days at 28 days defined as days alive and without intubation.(Between day 1 and day 28)
- Hospital length of stay.(through patient participation period,180 days maximum)
- ROX index(6, 12 and 24 hours)
- Discomfort associated with the interface as assessed by a visual analogic scale from zero (no discomfort) to 100 (maximum possible discomfort).(12 and 24 hours)
- Level of oxygenation assessed by blood gas that will be sampled on the request of the physician in charge (clinical purpose only).(First 24 hours or until intubation)
- Use of NIV for one of the following predefined indication criteria.(through study completion)
- Death within the hospital and time to death.(through patient participation period,180 days maximum)
- Time from randomization to intubation.(28 days)