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

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug336 BCG vaccine Wiki 0.58
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (8)


Name (Synonyms) Correlation
D003327 Coronary Disease NIH 0.41
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.35
D006331 Heart Diseases NIH 0.35
D008173 Lung Diseases, Obstructive NIH 0.33
D014777 Virus Diseases NIH 0.12
D007239 Infection NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0006510 Chronic pulmonary obstruction HPO 0.35
HP:0006536 Pulmonary obstruction HPO 0.33

There is one clinical trial.

Clinical Trials


1 Clinical Evaluation of Ventilator Innovation Product in Colombia in the SARS Pandemic Covid 19, Unisabana Herons - A Cohort Study - Phase 1

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.

NCT04497623 Covid19 Device: Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours

Primary Outcomes

Description: Maintenance: less than 20% drop in PaO2 with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.

Measure: Improvement or maintenance of the oxygenation level measured by PaO2

Time: 24 hours

Description: 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.

Measure: Improvement or maintenance of the oxygenation level measured by O2 Saturation

Time: 24 hours

Secondary Outcomes

Description: 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.

Measure: Improvement or maintenance of adequate levels of carbon dioxide measured by PaCO2

Time: 24 hours

Description: 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.

Measure: Improvement or maintenance of adequate levels of HCO3

Time: 24 hours

Description: 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.

Measure: Improvement or maintenance of adequate levels of excess base.

Time: 24 hours

Description: 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.

Measure: Improvement or maintenance of adequate levels of blood pH

Time: 24 hours

Description: 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.

Measure: Improvement or maintenance of PaO2/FiO2

Time: 24 hours

Description: 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.

Measure: Improvement or maintenance of SatO2/FiO2

Time: 24 hours

Description: Present or absent outcome

Measure: Uninterrupted and faultless operation in the period of use of the ventilator

Time: 24 hours

Description: Peak pressure >35 CM H20.

Measure: Inspiratory peak pressure> 35 cm H2O that does not have a clinical explanation other than the ventilator (such as a mucus plug)

Time: 24 hours

Description: Present or absent outcome

Measure: Plateau airway pressure> 30 cm H2O that does not have a clinical explanation other than the ventilator

Time: 24 hours

Description: Present or absent outcome

Measure: VT> 8 cc / kg of ideal weight that does not have a clinical explanation other than the ventilator

Time: 24 hours

Description: Present or absent outcome

Measure: 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)

Time: 24 hours

Description: Present or absent outcome

Measure: Pneumothorax (not having an explanation other than ventilatory support, such as the insertion of a central catheter)

Time: 24 hours

Description: Present or absent outcome

Measure: Pneumomediastinum (not having an explanation other than ventilatory support, such as the insertion of a central catheter)

Time: 24 hours

Description: Present or absent outcome

Measure: Subcutaneous emphysema (not having an explanation other than ventilatory support, such as the insertion of a central catheter)

Time: 24 hours

Description: Present or absent outcome

Measure: 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

Time: 24 hours

Description: Present or absent outcome

Measure: Cardiac arrest without a clinical explanation other than the ventilator

Time: 24 hours

Description: Present or absent outcome

Measure: Death without a clinical explanation other than the ventilator

Time: 24 hours

Description: Present or absent outcome

Measure: Elevation of creatinine that does not have a clinical explanation other than the ventilator

Time: 24 hours

Description: Present or absent outcome

Measure: Elevation of BUN that does not have a clinical explanation other than the ventilator

Time: 24 hours

Description: Present or absent outcome

Measure: Digestive bleeding without a clinical explanation other than ventilator

Time: 24 hours

Description: Present or absent outcome

Measure: Stress ulcers (upper gastrointestinal tract) without a clinical explanation other than ventilator

Time: 24 hours

Description: Present or absent outcome

Measure: Pneumonia associated with ventilator.

Time: 24 hours

Description: Present or absent outcome

Measure: Tracheobronchitis associated with ventilator.

Time: 24 hours

Description: Present or absent outcome

Measure: Critical care polyneuropathy that does not have a different explanation for the use of the ventilator and / or muscle relaxants necessary for mechanical ventilation

Time: 24 hours

Description: Present or absent outcome

Measure: Critical care myopathy that does not have a different explanation for the use of the ventilator and / or muscle relaxants necessary for mechanical ventilation

Time: 24 hours


No related HPO nodes (Using clinical trials)