Clinical Evaluation of Ventilador Innovation Product in Colombia in the SARS COVID 19 Pandemic, Unisabana Herons.

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.

Conditions

• Covid19

Interventions

DEVICE

Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours

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.

Sponsors & Collaborators

• Universidad de la Sabana

  collaborator OTHER

• Fundación Cardioinfantil Instituto de Cardiología

  collaborator OTHER

• Clínica Universidad de La Sabana

  collaborator UNKNOWN

• Fundación Neumologica Colombiana

  lead OTHER

Principal Investigators

• Luis F Giraldo-Cadavid, MD, PhD · Fundación Neumológica Colombiana y Universidad de La Sabana

• Fabio A Varon-Vega, MD, PhD(c) · Fundacion Neumologica Colombiana

• Alirio R Bastidas, MD, MSc · Universidad de la Sabana

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-28

Primary Completion

2020-08-13

Completion

2020-09-20

Countries

• Colombia

Study Locations