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NCT04497623: SabanaHerons
Clinical Evaluation of Ventilador Innovation Product in Colombia in the SARS COVID 19 Pandemic, Unisabana Herons.
NA trial testing Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours in Covid19 in 5 participants. Completed in 20 September 2020.
13 August 2020
Quick facts
| Lead sponsor | Fundación Neumologica Colombiana |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 5 |
| Start date | 28 July 2020 |
| Primary completion | 13 August 2020 |
| Estimated completion | 20 September 2020 |
| Sites | 3 locations across Colombia |
Drugs / interventions tested
- Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours
Conditions studied
- Covid19 — all drugs for Covid19 →
Sponsor
Fundación Neumologica Colombiana
Who can join
Adults 18 to 70, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The development and implementation of a low-cost mechanical ventilator in a low-middle-income country during the COVID-19 pandemic: The Unisabana-HERONS.
Giraldo-Cadavid LF, Echeverry J, Varón-Vega F, Bastidas A, et al · · 2024 · cited 1× · PMID 38756610 · DOI 10.1016/j.heliyon.2024.e30671
Verify or expand the search:
- PubMed search for NCT04497623
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fundación Neumologica Colombiana trials
Trials by the same sponsor.
- NCT04607343 — Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea · NA · suspended
- NCT03109171 — Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04497623 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación Neumologica Colombiana
- Last refreshed: 24 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04497623.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing