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

NACompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

July 28, 2020

Primary Completion Date

August 13, 2020

Study Completion Date

September 20, 2020

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.

Trial Locations (3)

210001

Clinica Universidad de la Sabana, Chía

250001

Universidad de la Sabana, Chía

110131399

Fundacion Neumologica Colombiana, Bogotá

All Listed Sponsors
collaborator

Universidad de la Sabana

OTHER

collaborator

Fundación Cardioinfantil Instituto de Cardiología

OTHER

collaborator

Clínica Universidad de La Sabana

UNKNOWN

lead

Fundación Neumologica Colombiana

OTHER

NCT04497623 - Clinical Evaluation of Ventilador Innovation Product in Colombia in the SARS COVID 19 Pandemic, Unisabana Herons. | Biotech Hunter | Biotech Hunter