Descriptive Analysis of the Functioning of the Ventijet Mechanical Ventilator During the COVID-19 Health Crisis in Patients With Acute Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Oxygenation efficiency (PaO₂ variation at 1 hour)
研究概览
简要总结
This prospective, non-randomized, single-arm, proof-of-concept clinical trial evaluates the physiological performance and safety of the Ventijet System, a hybrid ventilation system based on continuous high-velocity gas flow. The system was conceived during the coronavirus disease 2019 (COVID-19) pandemic as a response to ventilator shortages, building upon a previously patented continuous-flow nozzle system developed by Dr. Lucas Picazo in the 1990s. The concept combines the physiological benefits of continuous flow ventilation (CFV) with the potential ease of design, monitoring, and scalability.
Patients with moderate acute respiratory distress syndrome (ARDS) - defined by a ratio of arterial partial pressure of oxygen to inspired oxygen fraction (PaO₂/FiO₂) between 150 and 200 mmHg - were first stabilized on a conventional mechanical ventilator (Puritan Bennett 840, PB840) using lung-protective settings. They were then transitioned to the Ventijet system following a structured protocol that included real-time monitoring and esophageal pressure measurements.
The primary endpoint was oxygenation, measured as the change in PaO₂ after one hour of ventilation with the Ventijet system compared to baseline values under conventional ventilation. The study was designed to demonstrate non-inferiority, with a predefined margin of ±20 mmHg in PaO₂.
Secondary outcomes included carbon dioxide clearance (PaCO₂), respiratory system mechanics, safety events, and feasibility in intensive care unit (ICU) conditions.
详细描述
This is a prospective, interventional, single-center clinical study conducted to evaluate the physiological effects and safety of a novel ventilation system-continuous flow ventilation with Ventijet-in adult patients diagnosed with moderate acute respiratory distress syndrome (ARDS). The objective was to compare gas exchange and pulmonary mechanics between conventional pressure-controlled ventilation and the Ventijet system, which delivers continuous flow through a high-velocity nozzle.
Ventijet is a prototype mechanical ventilator developed during the COVID-19 pandemic, motivated by the urgent need for scalable and physiologically effective ventilatory support. The system builds on the concept of continuous-flow extratracheal jet ventilation (VC-ET), originally described and patented by Dr. Lucas Picazo in the 1990s. It generates a high-speed continuous gas stream via a proximally placed nozzle (tobera), which creates an expiratory braking effect. This facilitates alveolar recruitment throughout the respiratory cycle while maintaining low airway pressures and small tidal volumes. Unlike classical jet systems, Ventijet integrates real-time safety monitoring and operates using time-cycled, volume-controlled settings, making it suitable for intensive care unit (ICU) use.
Inclusion and Exclusion Criteria
Patients were screened in the ICU and included if they met all of the following:
- Age ≥ 18 years
- Intubated and on invasive mechanical ventilation
- Diagnosis of moderate ARDS (PaO₂/FiO₂ ratio between 150-200 mmHg, Berlin definition)
- Richmond Agitation-Sedation Scale (RASS) score of -5 (deep sedation)
- Stable hemodynamic and ventilatory parameters
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
盲法说明
No masking was applied. All investigators and clinicians were aware of the ventilation mode at each study phase.
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.
- •Invasive mechanical ventilation via endotracheal tube.
- •Diagnosis of moderate ARDS according to the Berlin Definition (PaO₂/FiO₂ between 150 and 200 mmHg with PEEP ≥ 5 cmH₂O).
- •Lung-protective ventilation strategy prior to inclusion (VT ≤ 6 mL/kg PBW, PEEP titrated to transpulmonary pressure 0-2 cmH₂O).
- •Deep sedation with RASS score of -5 at the time of inclusion.
- •Informed consent obtained from the patient's legal representative.
排除标准
- •Known obstructive pulmonary disease (e.g., COPD, asthma).
- •Severe hemodynamic instability or uncontrolled shock.
- •Pregnancy.
- •Do-not-resuscitate (DNR) orders or limitations of life support.
- •Anticipated need for ECMO in the next 24 hours.
- •Presence of pneumothorax or bronchopleural fistula.
- •Contraindications to esophageal pressure monitoring.
研究组 & 干预措施
Continuous Flow Ventilation with VENTIJET
All patients were initially ventilated with a conventional mechanical ventilator (PB840) under lung-protective settings. After a 1-hour stabilization and baseline assessment period, patients were transitioned to continuous flow ventilation using the Ventijet system for up to 24 hours, followed by reconnection to the conventional ventilator for post-intervention follow-up.
干预措施: VENTIJET system (Device)
结局指标
主要结局
Oxygenation efficiency (PaO₂ variation at 1 hour)
时间窗: 1 hour after connection to Ventijet system.
Change in arterial partial pressure of oxygen (PaO₂) measured by arterial blood gas analysis after 1 hour of ventilation with the Ventijet system, compared to PaO₂ under conventional mechanical ventilation (PB840) after 1 hour of stabilization (conventional-1h phase).
次要结局
- Change in arterial partial pressure of carbon dioxide (PaCO₂) after 1 hour of ventilation with VENTIJET compared to conventional ventilation.(1 hour after connection to the Ventijet system.)
研究者
Lucía Picazo Moreno
Principal Investigator and Intensive Care Specialist at Hospital del Mar
Hospital del Mar