Status:
COMPLETED
Clinical Evaluation of Ventilador Innovation Product in Colombia in the SARS COVID 19 Pandemic, Unisabana Herons.
Lead Sponsor:
Fundación Neumologica Colombiana
Collaborating Sponsors:
Universidad de la Sabana
Fundación Cardioinfantil Instituto de Cardiología
Conditions:
Covid19
Eligibility:
All Genders
18-70 years
Phase:
NA
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 li...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04497623
Start Date
July 28 2020
End Date
September 20 2020
Last Update
September 24 2020
Active Locations (3)
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1
Fundacion Neumologica Colombiana
Bogotá, Bogota D.C., Colombia, 110131399
2
Clinica Universidad de la Sabana
Chía, Cundinamarca, Colombia, 210001
3
Universidad de la Sabana
Chía, Cundinamarca, Colombia, 250001