Interaction Between Diaphragm and Cardiac Function During Weaning From Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Failure at the spontaneous breathing trial
研究概览
简要总结
Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. While diaphragm dysfunction and pulmonary edema are two main causes of weaning failure, there are currently no data that quantify their respective contribution neither their potential co-existence. During weaning from mechanical ventilation, heart and lung interaction plays a major role. As a key factor, diaphragm function is therefore certainly involved in the occurrence of weaning-induced pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced pulmonary edema have not been simultaneously investigated so far. This current project aims at exploring the relationship between diaphragm dysfunction and pulmonary in patients experiencing weaning failure. The objectives are 1) to quantify the respective contribution and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to investigate the role of diaphragm function in the occurrence of weaning induced pulmonary edema.
详细描述
The study will take place in the Medical ICU of Pitié-Salpêtrière Hospital in Paris. The ICU have an established and successful clinical research program and infrastructure.
ICU patients will be enrolled if eligible (based on inclusion and non inclusion criteria) after their first spontaneous breathing trial failure.
Diaphragm function will be assessed by its capacity to generate a pressure with the phrenic nerves stimulation technique (reference method) and by ultrasonography (thickening fraction). Weaning induced pulmonary edema will be diagnosed with cardiac echo and markers of plasma contraction (plasma protein concentration).
Phrenic nerves stimulation, diaphragm and cardiac ultrasound will be repeated as part of the research before the spontaneous breathing trial.
After obtaining consent and before starting the second spontaneous breathing trial, clinical and biological will be collected. EKG and maximal inspiratory pressure will be done. Then, a diaphragm ultrasound and cardiac echo will be done and the phrenic nerves stimulation method will be undertaken. After these measurements, the spontaneous breathing trial will start. At the end of the spontaneous breathing trial (30 minutes with pressure support 7 cmH2O and 0 positive end expiratory pressure) or sooner in case of intolerance (respiratory distress), a new cardiac echo and diaphragm ultrasound will be performed as part of standard care before resuming the initial ventilator settings. As recommended by the usual medical practice, a second phrenic nerves stimulation will be eventually done after resuming the initial ventilator settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients adult (age ≥ 18 years)
- •Intubation and invasive mechanical ventilation longer than 48 hours;
- •Failure to the first spontaneous breathing trial;
- •Presence of weaning readiness criteria
- •Oral informed consent
- •Patient with affiliation to the french healthcare system
排除标准
- •Pregnant women
- •Patient opposition
- •Contraindication to perform magnetic phrenic nerves stimulation technique (chest tube, cardiac pacemaker or implanted defibrillator, cervical implants, chest drains,...)
- •Impossibility to consider ventilator weaning (total ventilator dependence : preexisting neuromuscular disorders, cervical spine injury...)
研究组 & 干预措施
Patient difficult to wean
Repetition of medical examinations performed as part of the care. All patients will have a cardiac echo examination and diaphragm function assessment before the spontaneous breathing trial.
干预措施: Repetition of medical examinations performed as part of the care (Other)
结局指标
主要结局
Failure at the spontaneous breathing trial
时间窗: During or at the end of the spontaneous breathing trial
Weaning failure defined by the criteria of the International Conference on Weaning (Boles et al. ERJ 2007)
次要结局
- Rate of patients with diaphragm dysfunction(At the end of the patient participation (Day 3))
- Rate of patients with weaning induced pulmonary edema(At the end of the patient participation (Day 3))
- Rate of patients with diaphragm dysfunction and weaning induced pulmonary edema(At the end of the patient participation (Day 3))