Clinical Evaluation of Ventilator Innovation Product in Colombia in the SARS Pandemic Covid 19, Unisabana Herons - A Cohort Study - Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 6
- 主要终点
- Improvement or maintenance of the oxygenation level measured by O2 Saturation
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of the Unisabana-Herons invasive mechanical ventilator designed to provide the basic ventilatory support necessary to preserve the life of patients with respiratory failure and indication of mechanical ventilation, especially for those who suffer from acute respiratory distress syndrome (ARDS) when conventional commercial invasive ventilators are not available in the context of the health emergency due to the COVID-19 epidemic.
The Unisabana-Herons ventilator allows to precisely configure the respiratory rate, tidal volume (or inspired air volume), inspiratory time, the inspiration: expiration ratio, the positive pressure at the end of expiration (PEEP), the inspired fraction of oxygen and inspiratory air flow, parameters that allow managing the respiratory failure associated with COVID-19. The ventilator also monitors peak inspiratory pressures (PIP), mean, PEEP, plateau, and graphs in real time the pressure-time, volume-time, flow-time curves, which allows detecting when one of these is at levels dangerous to induce ventilator trauma (barotrauma and volutrauma) and thus ensure effective and safe ventilation, so as to avoid ventilator-induced lung injury.
详细描述
The Unisabana-Herons ventilator is an invasive mechanical ventilator that works on the same principles of invasive positive pressure mechanical ventilators that have existed for 80 years. Although the effectiveness of ventilatory assistance in saving human lives was known since biblical times, the first mechanical ventilators only appeared in 1800 and it was in 1900 when the first positive pressure ventilators were manufactured, which have a turning point in 1940 as a result of the polio epidemic, when invasive positive pressure mechanical ventilators were developed that could be used massively and have evolved to current models. These positive pressure fans completely replaced the first negative pressure models, have abundant support in the scientific literature, and are the most commonly used today.
Since the beginning of the COVID-19 epidemic in Colombia, the University of La Sabana, a multidisciplinary team in order to find solutions to deal with the disease, and its first project, consisted in the design and manufacture of an invasive mechanical ventilator (Ventilator Unisabana-Herons) able to supply the basic ventilatory needs of the patient with severe respiratory failure due to COVID-19 at the time when the installed capacity of classic commercial mechanical ventilators is exhausted. The Unisabana-Herons ventilator was built based on those recommended by INVIMA, the MHRA (UK Medicines and Devices Regulatory Agency) and the FDA, to provide efficient and safe volume controlled ventilation to patients with indications. of mechanical ventilation for respiratory failure according to the ventilatory modes already affected that have strong scientific evidence.
This study seeks to evaluate the effectiveness, usability and safety of the Unisabana-Herons ventilator for the management of patients with an indication for invasive mechanical ventilatory support, admitted to level III and IV university hospitals with Intensive Care services enabled through a cohort study of 5 patients with a 24-hour follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years and younger than 70 years with indication of volume-controlled mechanical ventilation for more than 24 hours.
- •Patients with acute respiratory failure (PaO2 / FiO2 <300) requiring volume-controlled mechanical ventilation. These patients may or may not have COVID-19 (at the current time of the epidemic, it is assumed that every patient with an indication for mechanical ventilation is a possible case of COVID-19).
- •Postoperative patients who require ventilatory support and are expected to need it for more than 24 hours.
- •Patients with traumatic brain injury and indication of mechanical ventilatory support with an expected duration greater than 24 hours
- •Patients with acute intoxication and respiratory depression and indication of mechanical ventilatory support with an expected duration greater than 24 hours
排除标准
- •Pregnant women
- •Patients with hypotension MAP <65 mmHg
- •Patients with PaO2 / FiO2 <100
- •Cerebral edema in cerebral protection and / or suspected endocranial hypertension
- •For those patients who are already receiving mechanical ventilation, the presence of one or more of the following criteria: PEEP> 8 cmH2O, plateau pressure> 30 cm H2O or FiO2> 70%
- •COVID-19 confirmed by RT-PCR.
结局指标
主要结局
Improvement or maintenance of the oxygenation level measured by O2 Saturation
时间窗: 24 hours
Maintenance: less than 20% drop in SatO2 levels with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
Improvement or maintenance of the oxygenation level measured by PaO2
时间窗: 24 hours
Maintenance: less than 20% drop in PaO2 with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
次要结局
- Pneumonia associated with ventilator.(24 hours)
- Improvement or maintenance of PaO2/FiO2(24 hours)
- Uninterrupted and faultless operation in the period of use of the ventilator(24 hours)
- Inspiratory peak pressure> 35 cm H2O that does not have a clinical explanation other than the ventilator (such as a mucus plug)(24 hours)
- Plateau airway pressure> 30 cm H2O that does not have a clinical explanation other than the ventilator(24 hours)
- Pneumothorax (not having an explanation other than ventilatory support, such as the insertion of a central catheter)(24 hours)
- Pneumomediastinum (not having an explanation other than ventilatory support, such as the insertion of a central catheter)(24 hours)
- Death without a clinical explanation other than the ventilator(24 hours)
- Improvement or maintenance of adequate levels of carbon dioxide measured by PaCO2(24 hours)
- Improvement or maintenance of adequate levels of excess base.(24 hours)
- VT> 8 cc / kg of ideal weight that does not have a clinical explanation other than the ventilator(24 hours)
- Subcutaneous emphysema (not having an explanation other than ventilatory support, such as the insertion of a central catheter)(24 hours)
- Improvement or maintenance of adequate levels of HCO3(24 hours)
- Decrease or increase in respiratory rate, tidal volume, PEEP, peak inspiratory pressure, FiO2, not due to a clinician order (changes not ordered by the clinical team but due to the ventilator variability)(24 hours)
- Improvement or maintenance of adequate levels of blood pH(24 hours)
- Improvement or maintenance of SatO2/FiO2(24 hours)
- Hemodynamic deterioration in the hour following the start of the Unisabana-Herons ventilator that requires a 100% increase in the dose of vasopressors and that does not have a clinical explanation other than the ventilator(24 hours)
- Elevation of creatinine that does not have a clinical explanation other than the ventilator(24 hours)
- Elevation of BUN that does not have a clinical explanation other than the ventilator(24 hours)
- Stress ulcers (upper gastrointestinal tract) without a clinical explanation other than ventilator(24 hours)
- Cardiac arrest without a clinical explanation other than the ventilator(24 hours)
- Digestive bleeding without a clinical explanation other than ventilator(24 hours)
- Critical care polyneuropathy that does not have a different explanation for the use of the ventilator and / or muscle relaxants necessary for mechanical ventilation(24 hours)
- Tracheobronchitis associated with ventilator.(24 hours)
- Critical care myopathy that does not have a different explanation for the use of the ventilator and / or muscle relaxants necessary for mechanical ventilation(24 hours)