Clinical Evaluation of Ventilador Innovation Product in Colombia in the SARS COVID 19 Pandemic, Unisabana Herons.
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

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.
    

Intervention name(s): Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours
Intervention type(s): Device
Intervention description(s): Recruited patients will receive volume-controlled mechanical ventilation (assist-control mode) using the Unisabana-Herons ventilator for 24 hours. Information on clinical, hemodynamic, and respiratory variables will be recorded from 30 minutes before the start of mechanical ventilation with the Unisabana-Herons ventilator. Recordings will be made in the first 4 hours every 15 minutes in the CFR, except for arterial blood gases which will be taken every 30 minutes. In the following 20 hours, arterial blood gas controls will be taken at hour 12 from the start of the ventilator and at hour 24. Other hemodynamic and respiratory variables will be recorded every hour from hour 4 of ventilator start until hour 24.
Intervention model: Single Group Assignment
Intervention model description: Enrolled patients receive mechanical ventilation using the Unisabana-Herons ventilator during 24 hours
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Mechanical ventilator; Covid 19; SARSCOV2