The Effects of Airway Closure, Expiratory Flow Limitation and of a Passive Chest Wall on the Onset of an Uncontrolled Expiration and on Intracranial Pressure. An Observational Clinical Study on Neurosurgical Patients. (The CeRes-CMV Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- The incidence of lung collapse
研究概览
简要总结
The impact of mechanical ventilation on intracranial perfusion is still not completely clarified. It is often assumed that raising airway pressure will invariably elevate the intracranial pressure, but this is not always the case.
The effects of airway pressure on intracranial pressure can depend on several factors, and among others, an uncontrolled expiration and consequent lung collapse may have an influence on cerebral perfusion.
This study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in critically ill neurosurgical patients during controlled mechanical ventilation.
Electrical impedance tomography measurements , oesophagus and gastric pressure, electrical activity of the diaphragm and intracranial pressure will be acquired in a synchronised manner during controlled mechanical ventilation. Moreover, airway opening pressure, expiratory flow limitation and recruitment/inflation ratio will be determined during controlled mechanical ventilation, on a daily bases until the patient recover his/her own spontaneous breathing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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;
- •MV expected for more than 72 hours;
- •Not pregnant;
- •Informed consent from patient or next of kin.
排除标准
- •Previously demonstrated paralysis of the diaphragm or know pathology of the phrenic nerve or neuromuscular disorder,
- •Chest tube,
- •Patients with clinical conditions that contraindicate the insertion of esophageal/gastric catheters (e.g., esophagus rupture, esophageal bleeding),
- •Pacemaker and/or implantable cardioverter defibrillator, these last being a contraindication for EIT.
- •Hemicraniectomy. In case of late hemicraniectomy (after patient inclusion), the patient will drop-out from the study.
- •Relative contraindication: in case of skull base fracture the patient can be included only if oesophageal/gastric and NAVA catheters can be inserted orally.
结局指标
主要结局
The incidence of lung collapse
时间窗: during the period of controlled mechanical ventilation, an average of 14 days
The incidence of an uncontrolled expiration and consequent expiratory lung collapse (determined by expiratory flow limitation, airway opening pressure and expiratory thoracic impedance) increased chest-wall elastance in neurosurgical patients.
Correlation between lung collapse and intracerebral pressure
时间窗: during the period of controlled mechanical ventilation, an average of 14 days
The correlation between an uncontrolled expiration (determined by expiratory flow limitation, airway opening and expiratory thoracic impedance), increased chest-wall elastance and intracranial pressure in neurosurgical patients.
Correlation between lung recruitability and intracerebral pressure
时间窗: during the period of controlled mechanical ventilation, an average of 14 days
The influence of lung recruitability (determined by recruitment/inflation ratio and changes of thoracic impedance) on intra cerebral pressure in neurosurgical patients.
次要结局
- 30-day and 90-days neurological and functional outcomes(90 days after hospital discharge)
- Number of days of mechanical ventilation(At ICU discharge, an average of 20 days)
- Intensive care unit (ICU) and hospital length of stay (LOS);(At ICU/hospital discharge, an average of 30 days)
- 90-days mortality from intensive care unit admission(90 days after hospital discharge)
研究者
Mariangela Pellegrini
Principal Investigator
Uppsala University