A Comparison of CPAP Delivered by Helmet and O2 Therapy With a Venturi Mask as First Line Intervention in Early ALI/ARDS
试验速览
- 阶段
- 不适用
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- The number of endotracheal intubations over the study period
研究概览
简要总结
Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute respiratory failure. However endotracheal intubation increases patient's discomfort and stress, and represents one of the most important predisposing factors for developing nosocomial bacterial pneumonia.
In conscious and cooperative patients non invasive positive pressure ventilation (NPPV) is a safe and effective mean for treating patients with acute respiratory failure (ARF), improving gas exchanges and reducing the rate of complication related to mechanical ventilation. Facial mask, that is the conventional interface for NIV, may induce intolerance because of pain, discomfort or claustrophobia leading to discontinuation of noninvasive ventilation and endotracheal intubation. Thus the improvement of the interface between patient and ventilator seems crucial to achieve a good tolerance allowing the prolonged application of noninvasive ventilation. Attempting to improve tolerability of patients we used a new interface consisting in Helmet made in latex-free PVC.
No prospective randomized controlled study has been published on the comparison between Continuous Positive Airways pressure (CPAP), delivered by an helmet and the medical treatment with Oxygen supplementation to treat early acute respiratory failure and acute lung injury.
Aim of the present protocol is to compare the efficacy of CPAP delivered with helmet and conventional medical treatment with oxygen supplementation via Venturi mask, to prevent ETI in patients with early hypoxemic ARF ( paO2 /FiO2 below 300).
详细描述
Prevention of Endotracheal Intubation by NIV and CPAP Mechanical ventilation through an endotracheal tube is a lifesaving procedure for acute respiratory failure. However endotracheal intubation increases patient's discomfort and stress, often requiring sedation, may cause injuries of the tracheal mucosa and tracheal stenosis (1), and represents one of the most important predisposing factors for developing nosocomial bacterial pneumonia.
In conscious and cooperative patients non invasive positive pressure ventilation (NPPV) is a safe and effective mean for treating patients with acute respiratory failure (ARF), improving gas exchanges and reducing the rate of complication related to mechanical ventilation .
Noninvasive ventilation and CPAP can be performed by of full face mask. Facial mask may induce intolerance because of pain, discomfort or claustrophobia leading to discontinuation of noninvasive ventilation and endotracheal intubation. During the early phases of hypoxemic acute respiratory failure if disconnection from mechanical ventilation occurs, patients can rapidly deteriorate gas exchanges with potential life threatening consequences. Despite improvements in facial masks characteristics, skin necrosis may occur in 7% of patients treated with NPPV for periods exceeding 72 hours.
Attempting to improve tolerability of patients we used a new interface consisting in Helmet made in latex-free PVC that allows patients to see, read and speech as during noninvasive pressure support ventilation (NPSV) and CPAP ( Continuos Positive Airways Pressure).
The efficacy of a helmet was recently tested and successfully applied to deliver CPAP as out of hospital treatment for patients with pulmonary edema. Recently in a matched controlled study we reported the efficacy of NPPV using the helmet to treat adult patients with hypoxemic ARF in comparison to NPSV using standard facial mask.
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
- •Acute Hypoxemic Respiratory failure
- •Severe Dyspnea at rest
- •Pulmonary infiltrates at chest X ray
- •PaO2/FiO2<300
- •Respiratory Rate > 30 breaths/min
排除标准
- •Age < 18 years
- •Patients belonging to Class II-III-IV of the NYHA
- •Unstable angina and myocardial infarction/ cardiac surgery within the previous 3 months
- •Intubation refused or contraindicated
- •Acute Respiratory Acidosis pH < 7.30 and PaCO2 > 50 mmHg
- •More than 3 organ failures
- •Systolic Pressure < 90 mmHg, under fluid resuscitation or Epinephrine or Norepinephrine > 0.1 gamma/Kg/min
- •EKG instability with ventricular arrhythmias
- •EXPECTED surgery during the 48 hours following the enrollment
- •Coma or seizures
- •Decreased level of consciousness (GCS <12)
- •Inability to clear secretions
- •Pre-defined intubation criteria
结局指标
主要结局
The number of endotracheal intubations over the study period
时间窗: period during the ICU stay
次要结局
- The complications not present on admission(period during the icu stay)
- The improvement of gas exchange(period during icu stay)