A Prospective, Randomized and Controlled Study Estimating the Neurally Adjusted Ventilatory Assist (NAVA) Versus the Pressure Support Ventilatory (PSV) in Difficult Weaning From Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Duration of weaning from the mechanical invasive ventilation.
研究概览
简要总结
The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
详细描述
- Background: The NAVA is a new mode of ventilation which works from the continuous recording of the electromyogram of the diaphragm. In theory, the NAVA delivred a proportional and synchronous assistance, to respiratory efforts allowing a more adequate ventilatory support. However, no study estimates the NAVA in the weaning from mechanical ventilation.
- Purpose: The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
- Detailed description: Approximately 20 to 25 % of the patients under mechanical ventilation who have the general criteria of weaning will not pass a first SBT (Spontaneous Breathing Trial). At this moment, the management of the weaning ventilatoire are made with PSV. The NAVA is proportional assistance and depends on the intensity of the electric diaphragmatic signal (Edi). The respiratory effort of the patient is directly detected from the Edi signal. In theory, the NAVA is a proportional and synchronous respiratory.
- After a first failure of a SBT, patients respecting the inclusion criteria and exlusion criteria described above are then included in the study and randomized in two groups (control group or NAVA group).
- In the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
- In the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
- Twice a day, the criteria of SBT are looked for. When they are present, a SBT is realized. If it is a success, the patient will be extube. If it is a failure, the patient will be reventilated in PSV or NAVA according to their group. A non-invasive ventilation preventive or of "rescue" can be administered post-extubation according to criteria. The reintubated criteria are also defined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age >18 years
- •Under mechanical ventilation > 48 hours
- •A first failure of a SBT
- •Plateau pressure 30cmH2O with tidal volume 8ml / kg
- •SpO2 ≥ in 90 % with a FiO2 ≥ 50 %, or PaO2 / FiO2 > 150mmHg
- •Positive expiratory pressure 8cmH2O
- •No more of one mg/hour of noradrenaline or adrenalin
- •Temperature >36 and <39°C.
- •Stable neurological state (Glasgow scale > 4) without sedation (or very low sedation).
- •Consent, dated and signed by the patient or his representative.
排除标准
- •Contraindications to the NAVA (recent high digestive suture or oesophageal varices bleeding < 4 days).
- •Pregnant woman.
- •Age <18 years.
- •Tracheotomy.
- •Cardiac arrest with a reserved neurological prognostic.
- •Therapeutic limitation.
研究组 & 干预措施
NAVA group
Management of the difficult weaning from mechanical ventilation by the NAVA.
干预措施: Neurally adjusted ventilatory assist (Device)
Control group
Conventional management of the difficult weaning from mechanical ventilation, with the pressure ventilation.
干预措施: Noninvasive pressure support ventilation (Device)
结局指标
主要结局
Duration of weaning from the mechanical invasive ventilation.
时间窗: 48 hours after the extubation
This duration is defined by the period between the first failure of the spontaneous breathing trial (SBT) and 48 hours after the extubation.
次要结局
- Length of intensive care unit stay(28th day)
- Rate of ventilator-associated pneumonia(28th day)
- Duration of hospitalization(28th day)
- Duration between the inclusion and the success of the SBT(28th day)
- Duration of invasive mechanical ventilation(28th day)
- Rate of failure of SBT(28th day)
- Rate of success of SBT(28th day)