Use of (Continous Positive Airway Pressure) CPAP in the Management of Acute Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Proportion of patients with intubation criteria within 7 days
研究概览
简要总结
Acute respiratory failure (ARF) is a frequent medical emergency, involving high costs for health organizations and patients who often require intensive care and respiratory assistance. According to an international study, 61% of hypoxemic patients in intensive care receive invasive ventilation [3]. Invasive mechanical ventilation is often unavailable in low-income countries and non-invasive ventilatory supports such as continuous positive airway pressure (CPAP) and high-flow oxygen therapy (HFO) were very useful during the COVID-19 pandemic. They reduced the rate of intubation and ICU admissions. In addition, CPAP can be used without a ventilator, no electricity is required. So, it could be a support of choice in low-income countries.
Used of Boussignac-type CPAP could potentially reduce the recourse to intubation in patients with acute hypoxemic respiratory failure in a context where access to invasive ventilation remains very limited.
详细描述
- Hypothesis :
The use of Boussignac-type CPAP could reduce the need for intubation in patients with acute respiratory failure in a setting where access to invasive ventilation remains very limited. 2. Objectives
2.1 Primary Objective
The primary objective is to evaluate the effect of CPAP use on the occurrence of intubation criteria at 7 days in patients presenting with ARF in the emergency department.
2.2 Secondary Objectives
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
- 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
- •All patients aged 18 years and older will be included in the study if they meet at least one of the following criteria :
- •Acute respiratory distress, defined as dyspnea respiratory rate ≥ 25 cycles/min
- •Hypoxemia, defined as the need for more 6 liters of oxygen to maintain an oxygen saturation (SpO2) of ≥ 92%. The fraction of inspired oxygen (FiO2) will be estimated using the 3% rule.
排除标准
- •Patients with any of the following criteria will not be included in the study:
- •Pregnant or breastfeeding women
- •Persons deprived of their liberty
- •Exacerbation of asthma, chronic obstructive pulmonary disease, or another chronic respiratory disease
- •Moderate to large amount of unilateral or bilateral undrained pleural effusion
- •Contraindication to CPAP: patient refusal, undrained pneumothorax, chest injury, repeated or large vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, or tetraplegia in the initial phase
- •Cardiac arrest, severe arrhythmias, shock requiring the use of vasopressors (norepinephrine, adrenaline, dopamine)
- •Altered level of consciousness (Glasgow Coma Scale score < 13), repeated seizures, or status epilepticus
- •Medical decision to limit treatment: no intubation, no admission to intensive care
- •Refusal to participate in the study or participation in another interventional study on respiratory distress or acute respiratory failure.
研究组 & 干预措施
CPAP group
Continuous CPAP (with Boussignac valve) for the first 6-12 hours, then alternating with standard oxygen therapy. CPAP pressure= 7.5 cmH2O (25L/min) then variations of +/- 2.5 cmH20 according to clinical response and tolerance until weaning from oxygen or presence of intubation criteria
干预措施: CPAP (Other)
Standard group
Oxygen therapy as required using, simple face masks or high concentration face masks until there are criteria for intubation, or withdrawal from oxygen.
结局指标
主要结局
Proportion of patients with intubation criteria within 7 days
时间窗: 7 days after randomization
The proportion of patients requiring endotracheal intubation within 7 days after randomization. Intubation will be defined as the insertion of an endotracheal tube for invasive invasive mechanical ventilation
次要结局
- All cause mortality at 28 days(28 days after randomization)
- Organ failure-free days at 7 days(7 days after randomization)
- CPAP tolerance Assessment(7 days after intiation CPAP)
研究者
Ismael Guibla
Clinical doctor
Université NAZI BONI