Investigating the Effects of Expiratory Flow Limitation and the Effects of Spontaneous Breathing on Intracranial Pressure. An Observational Clinical Study on Neurosurgical Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Correlation between uncontrolled expiration and intracranial pressure
研究概览
简要总结
Mechanical ventilation (MV) is a life-saving supportive therapy and one of the most common interventions implemented in intensive care.
To date, only the inspiratory phase of breathing has been extensively investigated, and new MV methods have been implemented to reduce its harmful effects. Despite this, lung injury still occurs and propagates, causing multiorgan failure and patient deaths. The expiratory phase is considered unharmful and is not monitored or assisted during MV. In animal experiments, we recently showed that the loss of diaphragmatic contraction during expiration can harm the lungs during MV. During mechanical ventilation, the expiratory phase of breathing is completely disregarded. However, in all conditions that promote lung collapse, peripheral airways gradually compress and close throughout the expiration, potentially worsening lung injury.
This cyclical lung collapse and consequent air-trapping may have an impact on the Starling resistor mechanisms that regulate venous return from the brain, potentially affecting cerebral perfusion and intracranial pressure.
This study will investigate the incidence and the consequences of an uncontrolled expiration and expiratory lung collapse in spontaneously breathing critically ill neurosurgical patients during 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, on a daily bases during assisted mechanical ventilation.
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
Correlation between uncontrolled expiration and intracranial pressure
时间窗: During the period of assisted mechanical ventilation, an average of 14 days
The influence of an uncontrolled expiration (defined by expiratory flow, expiratory EAdi and thoracic impedance) on intracranial pressure in neurosurgical patients.
Incidence of uncontrolled expiration
时间窗: during the period of assisted mechanical ventilation, an average of 14 days
The incidence of uncontrolled expiration and consequent expiratory lung collapse (determined by changes in expiratory flow and time constant) during assisted ventilation in neurosurgical patients.
次要结局
- 90-days mortality from intensive care unit admission(90 days after hospital discharge)
- Number of days of mechanical ventilation(At ICU discharge, an average of 20 days)
- 30-day and 90-days neurological and functional outcomes(90 days after hospital discharge)
- Intensive care unit (ICU) and hospital length of stay (LOS)(At ICU/hospital discharge, an average of 30 days)
研究者
Mariangela Pellegrini
Principal Investigator
Uppsala University