Bag CPAP Versus Standard Oxygen Care for the Management of Acute Hypoxemic Respiratory Failure in Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Percentage of patients with criteria for intubation at day 7
研究概览
简要总结
Acute Hypoxemic Respiratory Failure (AHRF) is one of the prevalent causes of admission around the world and is associated with high mortality in resource-limited settings. Limited access to invasive mechanical ventilation is among the contributing factors to poor outcomes. The Bag CPAP may be useful in reducing the need for intubation and therefore mortality in patients with AHRF but data are lacking. This study aims to determine whether the Bag CPAP compared to standard oxygen care, could reduce the percentage of patients with criteria for intubation in patients with AHRF.
This is a prospective randomized, open-label, controlled trial in which patients presenting at the emergency room in Rwanda will be randomly assigned to receive standard oxygen therapy or Bag CPAP. The primary endpoint is the percentage of patients with criteria for intubation at day 7. Secondary endpoints include the tolerance of the Bag CPAP, overall 28-day mortality rate, mortality rate of intubated patients on mechanical ventilation at day 28, percentage of patients intubated at 28 days, ventilator-free days at day 28, interval between the initiation of treatment and the onset of intubation criteria, the interval between the time when criteria for intubation are met and intubation, organ failure-free days at day 7 and length of hospital stay.
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
- •Inclusion criteria
- •All patients aged 18 years or older will be included in the study if they meet the following criteria:
- •De novo acute respiratory distress, characterized by the presence of dyspnea at rest, the use of accessory muscles for breathing, or a respiratory rate of 25 cycles per minute or more.
- •Hypoxemia, defined as a SpO2/FiO2 ratio less than 315 or a PaO2/FiO2 ratio less than 300 mmHg (if arterial blood gas is available) despite an oxygen therapy of 6 L/min. FiO2 will be estimated by the rule of 3% (Coudroy formula)(18,22). SpO2 should be less than 98% when assessing the SpO2/FiO2 ratio.
排除标准
- •Patients with one of the following criteria will be excluded from the study:
- •Absolute contraindications to CPAP: patient's refusal, uncontrollable vomiting, upper gastrointestinal bleeding, open or sucking chest wound, pneumothorax not drained, craniofacial trauma, severe burns to the face, severe upper airway obstruction, traumatic tetraplegia at the initial stage, tracheostomy.
- •Moderate to massive pleural effusion not drained
- •Cardiac arrest, severe ventricular arrhythmias, and shock defined as the need for vasopressor support (adrenaline, noradrenaline, or dopamine)
- •Altered level of consciousness (GCS below 12), repetitive convulsions, or status epilepticus
- •Do not intubate or resuscitate order before the inclusion in the study
- •Refusal to participate, already included in the study, enrollment in another interventional trial on acute respiratory failure
研究组 & 干预措施
Oxygen
Patients will receive oxygen
干预措施: Standard oxygen (Device)
Oxygen+Bag CPAP
Patients will receive oxygen and Bag CPAP sessions
干预措施: Bag CPAP (Device)
结局指标
主要结局
Percentage of patients with criteria for intubation at day 7
时间窗: Day-7
Predetermined criteria for endotracheal intubation and mechanical ventilation will be considered.
次要结局
- Organ failure-free days(Day-7)
- Mortality rate(Up to day-28)
- Duration of hospital stay(Up to day-28)
- Tolerance of the Bag CPAP(up to day-28)
- Mortality rate of intubated patients on mechanical ventilation(Up to day-28)
- Ventilator-free days(up to day-28)
- Percentage of patients intubated(Day-28)
研究者
Prof RWABIHAMA Jean Paul
Professor of Medicine
University of Rwanda