Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients: a Prospective, Randomized, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- The failure of the treatment, defined by a composite criteria
研究概览
简要总结
Mechanical ventilation is the first artificial support used in intensive care. After a period of invasive mechanical ventilation, patients should be separated from the ventilator (weaning period of mechanical ventilation). If weaning and extubation (removal of the tracheal tube) are successful in approximately 80 to 90% of resuscitation patients, 10 to 20% will develop acute respiratory failure (ARF) in the days following extubation. Obesity concerns 20 to 30% of resuscitation admissions in France. The pathophysiological changes in the obese patient explain the over-risk of desaturation and ARF in the post-extubation period. In order to decrease the incidence of extubation failure (need for reintubation within 48-72h post-extubation) of the most fragile patients, it is recommended in intensive care unit to prophylactically use various ventilatory support strategies and / or oxygenation, among which noninvasive ventilation (NIV) and oxygen therapy, which can be administered in two ways: High-Flow Humidified Nasal Oxygen Therapy (HFNO) or standard oxygen therapy. These strategies have never been compared in the obese post-extubation critically ill patient. Our hypothesis is that NIV is superior to oxygen to prevent the development of ARF in obese extubated patients in intensive care unit.
详细描述
Mechanical ventilation is the first artificial support used in intensive care unit (ICU). After a period of invasive mechanical ventilation, patients should be separated from the ventilator (weaning period of mechanical ventilation). If weaning and extubation (removal of the tracheal intubation tube) is successful in approximately 80 to 90% of resuscitation patients, 10 to 20% will develop acute respiratory failure (ARF) in the days following extubation . This incidence is higher in the patients most fragile in the respiratory field (obese patients, chronic obstructive pulmonary disease (COPD), elderly, heart failure, postoperative cardio-thoracic and / or abdominal surgery ...) . The management of post-extubation ARF consists of etiological treatment associated with ventilatory support which usually requires the use of new endotracheal intubation to deliver "invasive" artificial ventilation. This invasive ventilation is responsible for excess morbidity and excess mortality . Therefore, it is fundamental for the physician to prevent by all means the occurrence of ARF post-extubation. One of the most important causes of extubation failure is the imbalance between the burden imposed on the respiratory system and its ability to overcome it, leading to gas exchange abnormalities, namely hypoxia and hypercapnia. Ensuring adequate oxygenation is therefore essential after extubation. In ICU, oxygen therapy is commonly used to improve and provide adequate oxygenation .
Obesity, a major public health problem in the industrialized countries, concerns 10 to 20% of resuscitation admissions in France. It is associated with excess morbidity and longer mechanical ventilation time compared to the general population. Effect on mortality is controversial , some studies suggesting a protective or neutral effect of obesity , named "obesity paradox" . At the ventilatory level, several pathophysiological changes are combined and contribute to an increase in the incidence of respiratory complications . Pulmonary volumes are amputated, the Body Mass Index (BMI) being negatively correlated with the functional residual capacity and vital capacity. The compliance of the respiratory system is reduced by the weight of the chest wall. Decreased compliance and increased airway resistance lead to increased respiratory muscle work. All of these pathophysiological changes in the obese patient explain the over-risk of desaturation and ARF in the post-extubation period. In addition to the intrinsic risk factors associated with obesity, the post-extubation period is marked by numerous risk factors for the development of ARF and extubation failure.
However, the exploration of different modern modalities of adequate post-extubation oxygen therapy in obese resuscitation patients to prevent the occurrence of extubation failure or post-extubation ARF has never been studied.
For over 20 years, Non-Invasive Ventilation (NIV) has been an essential modality in the prevention ("preventive NIV") and management ("curative NIV") of respiratory failure in ICU. The advantages of this ventilation modality are: respect for airway defense mechanisms (speech and cough maintenance), elimination of laryngeal and tracheal trauma induced by an intubation tube, improved comfort, reduction of the risk of bronchopulmonary nosocomial infection .
An alternative to NIV is the simple administration of oxygen. Two devices delivering low oxygen flows are commonly used for oxygen therapy after extubation: the Venturi mask and the nasal cannulas. The nasal cannulas are preferred by patients and less likely to be removed, but they can cause discomfort due to dryness of nasal mucosa when oxygen flows greater than 4 L/min are used. The Venturi mask delivers predetermined oxygen concentrations ranging from 24 to 60%, but the mask is generally less comfortable than the nasal cannula and more likely to be displaced or removed . In clinical practice, the Venturi mask is more frequently used after extubation because critically ill patients breathe preferentially through an open mouth rather than the nose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult (age ≥ 18 years)
- •Subjects must be covered by public health insurance
- •Obese patients defined by a body mass index ≥ 30 kg/m²
- •Extubation after a length of mechanical ventilation >= 6 hours
- •Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
排除标准
- •Refusal of study participation or to pursue the study by the patient
- •Hypercapnia with a formal indication for NIV (PaCO2 ≥ 50 mmHg, formal indication for NIV)
- •Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included.
- •Pregnancy or breastfeeding
- •Anatomical factors precluding the use of NIV and/or HFNO
- •Absence of coverage by the French statutory healthcare insurance system
- •Patients with tracheostomy
- •Patients with CPAP for obstructive apnea syndrome
- •Patients with decision of no-reintubate (limitation)
研究组 & 干预措施
Oxygen Group
Patient will receive standard oxygenotherapy
干预措施: Oxygen group (Device)
NIV Group
Patient will receive non invasive ventilation
干预措施: NIV Group (Device)
结局指标
主要结局
The failure of the treatment, defined by a composite criteria
时间窗: 72 hours
The failure of the treatment, defined by a composite criteria combining the treatment failure, defined as reintubation for mechanical ventilation, switch to the other study treatment, or premature study-treatment discontinuation
次要结局
- Organ failure(Up to Day 7)
- ICU all-cause mortality(up to day 28)
- Incidence of acute respiratory failure(up to Day 7)
- Length of stay in ICU and in hospital(up to day 90)
- Oxygenation(Up to Day 7)
- Tracheal intubation rate(up to day 28)
