Clinical Evaluation of Ventilador Innovation Product in Colombia in the SARS COVID 19 Pandemic, Unisabana Herons.
- Conditions
- Covid19
- Interventions
- Device: Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours
- Registration Number
- NCT04497623
- Lead Sponsor
- Fundación Neumologica Colombiana
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
- Pregnant women
- Patients with hypotension MAP <65 mmHg
- Patients with PaO2 / FiO2 <100
- Cerebral edema in cerebral protection and / or suspected endocranial hypertension
- SOFA >9
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention arm Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours Patients with indication for volume-controlled mechanical ventilation
- Primary Outcome Measures
Name Time Method Improvement or maintenance of the oxygenation level measured by O2 Saturation 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 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.
- Secondary Outcome Measures
Name Time Method Pneumonia associated with ventilator. 24 hours Present or absent outcome
Improvement or maintenance of PaO2/FiO2 24 hours Stability is defined as a decrease of less than 20% in this variable with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
Uninterrupted and faultless operation in the period of use of the ventilator 24 hours Present or absent outcome
Inspiratory peak pressure> 35 cm H2O that does not have a clinical explanation other than the ventilator (such as a mucus plug) 24 hours Peak pressure \>35 CM H20.
Plateau airway pressure> 30 cm H2O that does not have a clinical explanation other than the ventilator 24 hours Present or absent outcome
Pneumothorax (not having an explanation other than ventilatory support, such as the insertion of a central catheter) 24 hours Present or absent outcome
Pneumomediastinum (not having an explanation other than ventilatory support, such as the insertion of a central catheter) 24 hours Present or absent outcome
Death without a clinical explanation other than the ventilator 24 hours Present or absent outcome
Improvement or maintenance of adequate levels of carbon dioxide measured by PaCO2 24 hours Maintenance is defined as a change of less than 20% in the levels of this variable with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
Improvement or maintenance of adequate levels of excess base. 24 hours Maintenance is defined as a change of less than 20% in the levels of this variable with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
VT> 8 cc / kg of ideal weight that does not have a clinical explanation other than the ventilator 24 hours Present or absent outcome
Subcutaneous emphysema (not having an explanation other than ventilatory support, such as the insertion of a central catheter) 24 hours Present or absent outcome
Improvement or maintenance of adequate levels of HCO3 24 hours Maintenance is defined as a change of less than 20% in the levels of this variable with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
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 Present or absent outcome
Improvement or maintenance of adequate levels of blood pH 24 hours Maintenance is defined as a change of less than 20% in the levels of this variable with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
Improvement or maintenance of SatO2/FiO2 24 hours Stability is defined as a decrease of less than 20% in this variable with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
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 Present or absent outcome
Elevation of creatinine that does not have a clinical explanation other than the ventilator 24 hours Present or absent outcome
Elevation of BUN that does not have a clinical explanation other than the ventilator 24 hours Present or absent outcome
Stress ulcers (upper gastrointestinal tract) without a clinical explanation other than ventilator 24 hours Present or absent outcome
Cardiac arrest without a clinical explanation other than the ventilator 24 hours Present or absent outcome
Digestive bleeding without a clinical explanation other than ventilator 24 hours Present or absent outcome
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 Present or absent outcome
Tracheobronchitis associated with ventilator. 24 hours Present or absent outcome
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 Present or absent outcome
Trial Locations
- Locations (3)
Fundacion Neumologica Colombiana
🇨🇴Bogotá, Bogota, Colombia
Universidad de la Sabana
🇨🇴Chia, Cundinamarca, Colombia
Clinica Universidad de la Sabana
🇨🇴Chía, Cundinamarca, Colombia