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

NCT04497623 | Completed

• 1 other identifier: 202006-25502
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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 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

Keywords

Mechanical ventilator; Covid 19; SARSCOV2

Outcome Measures

Primary Outcomes (2)

• Improvement or maintenance of the oxygenation level measured by PaO2

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

  24 hours

• Improvement or maintenance of the oxygenation level measured by O2 Saturation

  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.

  24 hours

Secondary Outcomes (25)

• Improvement or maintenance of adequate levels of carbon dioxide measured by PaCO2

  24 hours

• Improvement or maintenance of adequate levels of HCO3

  24 hours

• Improvement or maintenance of adequate levels of excess base.

  24 hours

• Improvement or maintenance of adequate levels of blood pH

  24 hours

• Improvement or maintenance of PaO2/FiO2

  24 hours

Study Arms (1)

Intervention arm

EXPERIMENTAL

Patients with indication for volume-controlled mechanical ventilation

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

Interventions

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

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Neumologica Colombiana: lead
• Universidad de la Sabana: collaborator
• Fundación Cardioinfantil Instituto de Cardiología: collaborator
• Clínica Universidad de La Sabana: collaborator

Study Sites (3)

Fundacion Neumologica Colombiana

Bogotá, Bogota D.C., 110131399, Colombia

Location

Clinica Universidad de la Sabana

Chía, Cundinamarca, 210001, Colombia

Location

Universidad de la Sabana

Chía, Cundinamarca, 250001, Colombia

Location

Related Publications (6)

• Petrucci N, Iacovelli W. Lung protective ventilation strategy for the acute respiratory distress syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003844. doi: 10.1002/14651858.CD003844.pub3.

  PMID: 17636739 BACKGROUND

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 BACKGROUND

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 BACKGROUND

• Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.

  PMID: 20197533 BACKGROUND

• Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, Davies AR, Hand LE, Zhou Q, Thabane L, Austin P, Lapinsky S, Baxter A, Russell J, Skrobik Y, Ronco JJ, Stewart TE; Lung Open Ventilation Study Investigators. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637-45. doi: 10.1001/jama.299.6.637.

  PMID: 18270352 BACKGROUND

• Giraldo-Cadavid LF, Echeverry J, Varon-Vega F, Bastidas A, Ramirez-Jaime A, Cardona AF, Lopez Vega CJ, Serrano-Mayorca CC, Garay D, Rincon DN, Oliveros H, Ramirez IA, Garcia-Gallo E, Enciso-Prieto VA, Ibanez-Prada ED, Camelo JC, Cucunubo L, Buitrago L, Paipa LA, Longas LC, Agudelo-Otalora LM, Porras Diaz NF, Rachid RR, Henao I RD, Pedraza S, Reyes LF. The development and implementation of a low-cost mechanical ventilator in a low-middle-income country during the COVID-19 pandemic: The Unisabana-HERONS. Heliyon. 2024 May 5;10(9):e30671. doi: 10.1016/j.heliyon.2024.e30671. eCollection 2024 May 15.

  PMID: 38756610 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Luis F Giraldo-Cadavid, MD, PhD

  Fundación Neumológica Colombiana y Universidad de La Sabana

  STUDY DIRECTOR

• Fabio A Varon-Vega, MD, PhD(c)

  Fundacion Neumologica Colombiana

  PRINCIPAL INVESTIGATOR

• Alirio R Bastidas, MD, MSc

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled patients receive mechanical ventilation using the Unisabana-Herons ventilator during 24 hours

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 4, 2020
• Study Start: July 28, 2020
• Primary Completion: August 13, 2020
• Study Completion: September 20, 2020
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (3)