Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (NAVA)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Evaluation of the variations of Electrical Activity of the Diaphragm in response to different levels of ventilatory assist at different degrees of lung inflation (different Positive End Expiratory Pressure values)
研究概览
简要总结
Primary Graft Dysfunction (PGD) respresents the leading cause of mortality in early post-operative period of Lung Tranplantation (LTx). Protective ventilatory strategy could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode that could allow to adopt this strategy. Aim of the study is to assess the feasibility of NAVA in the early post-LTx phase and to describe the breathing pattern and the physiological relationship between neural respiratory drive and different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback.
详细描述
Lung transplantation (LTx) is an important treatment option for select patients with end-stage pulmonary disease. Primary Graft Dysfunction (PGD) is the main cause of death; in the early period following LTx a protective ventilatory strategy (tidal volume - Vt of 6 mL/Kg + Positive End Expiratory Pressure) could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which neural inspiratory activity is monitored through the continuous recording of electrical activity of the diaphragm (EAdi). Actually, Guidelines about the adoption of a protective ventilatory strategy in the early post-opeartive period are lacking.
NAVA, because of its intrinsic properties (proportionality between respiratory drive and level of assist, prevention of diaphragm atrophy), could allow to reach the afore mentioned ventilatory strategy. So, aim of the study, is the evaluation of patients' neural breathing pattern during NAVA, in early post-operative period of LTx
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age > 18 y.o.
- •Admission to ICU for post-operative monitoring after LTx
- •Presence of spontaneous breathing activity
- •Sedation titrated to a target RASS between 0 and -2
- •Written informed consent obtained
排除标准
- •Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)
- •Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., INR > 2 and platelets count < 70.000/mm3)
- •Severe hemodynamic instability (noradenaline > 0.3 μg/kg/min and/or use of vasopressin)
- •Postoperative extracorporeal respiratory support (ECMO)
- •Pre-operative reconditioning of the transplanted lungs by means of ex-vivo lung perfusion (EVLP)
- •Lung retransplantation
- •Failure to obtain a stable EAdi signal
研究组 & 干预措施
NAVA group
NAVA ventilation
干预措施: NAVA ventilation (Device)
结局指标
主要结局
Evaluation of the variations of Electrical Activity of the Diaphragm in response to different levels of ventilatory assist at different degrees of lung inflation (different Positive End Expiratory Pressure values)
时间窗: One hour after the recovery of spontaneous breathing
Electrical Activity of the Diaphragm (EAdi) (microVolt)
Evaluation of the variations of Neuro-Mechanical Coupling (expressed as microVolt of EAdi /cmH2O of airway pressure Ratio) in response to different levels of ventilatory assist at different degrees of lung inflation
时间窗: One hour after the recovery of spontaneous breathing
Neuro-Mechanical Coupling (NMC) (microvolt/cmH2O)
Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist
时间窗: One hour after the recovery of spontaneous breathing
Tidal Volume (mL)
Evaluation of the variations of Neuro-ventilatory Efficiency (expressed as microvolt of EAdi / mL of Tidal Volume Ratio) in response to different levels of ventilatory assist at different degree of lung inflation
时间窗: One hour after the recovery of spontaneous breathing
Neuro-Ventilatory Efficiency (NVE) (microvolt/mL)
Evaluation of the changes in the patient's neural breathing pattern (expressed as respiratory rate) at different levels of ventilatory assist
时间窗: One hour after the recovery of spontaneous breathing
Respiratory rate (Breaths/min)
次要结局
- Evaluation of the feasibility of Plateau Pressure during NAVA(One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres)
- Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains(One hour after the recovery of spontaneous breathing)
- Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling)(One hour after the recovery of spontaneous breathing)
研究者
Giacomo Grasselli
Prof
Policlinico Hospital