Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS: a Multicentric Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Respiratory effort
研究概览
简要总结
Data comparing respiratory drive and effort in critically ill patients with acute respiratory distress syndrome associated to different severity of COVID-19 penumonia (CARDS) and to other risk factors are lacking. Objectives: To assess respiratory drive and effort of CARDS patients at the first transition from controlled to assisted spontaneous breathing. The second aim was the rate of a composite outcome including the need of higher level of sedation
详细描述
Multicenter cohort study in four Italian ICU including adults with moderate and severe CARDS (PaO2/FiO2 <100 mmHg) at ICU admission. An historical cohort of patients with ARDS from various etiologies used for comparison. Respiratory drive (P0.1), diaphragm electrical activity (EAdi), inspiratory effort derived from EAdi (∆PmusEAdi) and from deflection in airway pressure occluded (ΔPocc) (PmusΔPocc), dynamic transpulmonary driving pressure (ΔPL,dyn, the difference between peak and end-expiratory transpulmonary pressure) measured under assisted ventilation.
The main ventilatory pattern variables:
- Airway Occlusion Pressure (P0.1): Measurement of the decrease in airway pressure during an end-expiratory occlusion.
- Pmus-EAdi-derived (∆Pmus, EAdi): Measurement of the pressure generated by the respiratory muscles during inspiration derived by electrical activity of the diaphragm measurements.
- Transpulmonary pressure EAdi-derived (∆Plung,dyn): difference between peak and end-expiratory transpulmonary pressure .
- Occlusive Pressure Difference (∆Pocc): Evaluation of the pressure difference between the initial and final airway opening during inspiration.
- Pmus-∆Pocc-derived (∆Pmus, ∆Pocc): Measurement of the pressure generated by the respiratory muscles during inspiration derived by ∆Pocc (∆Pocc*0.75)
- Transpulmonary driving pressure ∆Pocc derived (∆Plung, ∆Pocc): calculated as (Peak airway pressure -PEEP) - 2/3 * ∆Pocc
- Diaphragmatic Electrical Activity (EAdi): Recording of the electrical activity of the diaphragm.
- Peak EAdi (EAdiPEAK): Determination of the highest recorded value of diaphragmatic electrical activity.
- Pressure time product of the trans-diaphragmatic pressure per breath and per minute(PTP/min): the integral of Pmusc-EAdi-derived during inspiration per breath.
- Inspiratory Delay (ID): Assessment of the time delay between the start of neural inspiration and the onset of mechanical ventilation.
- Neuro-ventilatory Efficiency (NVE): Measurement of the efficiency of the neural drive to the respiratory muscles.
- Peak Airway Opening Pressure (PawPEAK): Measurement of the peak pressure in the airway during inspiration.
- Inspiratory Pressure-Time Product (PmusEAdi/b): Calculation of the work of breathing by integrating the product of diaphragmatic electrical activity and the change in airway pressure during inspiration.
- Tidal Volume (VT): Measurement of the volume of air inspired and expired during each breath.
- Respiratory Rate: Calculation of the number of breaths per minute delivered by the mechanical ventilator.
- Inspiratory and Expiratory Time (Ti,MECH and Te,MECH): Determination of the duration of mechanical inspiration and expiration.
- Inspiratory Duty Cycle (TI/TTOT-neur): Calculation of the ratio of inspiratory time to total respiratory cycle time based on neural inspiration.
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
- •Patients with a diagnosis of acute respiratory distress syndrome based on the Berlin criteria.
- •Patients with ARDS due to confirmed COVID-19 through real-time RT-PCR on nasopharyngeal swabs or lower respiratory tract aspirates.
- •Patients who had received invasive mechanical ventilation for more than 72 hours.
- •Patients who were candidates for assisted ventilation.
- •Readiness for assisted ventilation, which was defined by the following criteria:
- •Improvement of the condition leading to acute respiratory failure.
- •Positive end-expiratory pressure lower than 10 cmH2O and inspiratory oxygen fraction lower than 0.
- •Richmond agitation sedation scale score between 0 and -
- •Ability to trigger the ventilator, i.e., decrease pressure airway opening by more than 3-4 cmH2O during a brief (5-10 seconds) end-expiratory occlusion test.
- •Hemodynamic stability without vasopressor or inotropes, except for dobutamine and norepinephrine infusion below certain thresholds (dobutamine <5 gamma/Kg/min and norepinephrine <0.3 gamma/Kg/min).
- •Normothermia.
排除标准
- •Patients affected by neurological or neuromuscular pathology and/or known phrenic nerve dysfunction.
- •Patients with any contraindication to the insertion of a nasogastric tube, such as recent upper gastrointestinal surgery or esophageal varices.
- •Patients < 18 years old
结局指标
主要结局
Respiratory effort
时间窗: 90 breaths
Evaluation of respiratory drive using ∆Pmus-EAdi derived, ∆Pmus-∆Pocc derived, PTP/min
Transpulmonary driving pressure
时间窗: 90 breaths
Evaluation of respiratory drive using ∆Plung, dynamic
Respiratory drive
时间窗: 90 breaths
Evaluation of respiratory drive using P0.1
Neuroventilatory coupling
时间窗: 90 breaths
Evaluation of respiratory drive using EAdi PEAK
次要结局
- Composite outcome(within forty eight hour from assisted spontaneous breathing)
- Intensive care unit mortality(Intensive care unit stay)
- Mortality(60 days after measurement)
研究者
Vito Fanelli MD, PhD
Associate Professor
University of Turin, Italy