Clinical trial NCT04497623: Clinical Evaluation of Ventilador Innovation Product in Colombia in the SARS COVID 19 Pandemic, Unisabana Herons.
Official title: Clinical Evaluation of Ventilator Innovation Product in Colombia in the SARS Pandemic Covid 19, Unisabana Herons - A Cohort Study - Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Mechanical ventilator
Covid 19
SARSCOV2
Lead sponsor: Fundación Neumologica Colombiana
Sponsor class: OTHER
Collaborators: name: Universidad de la Sabana
name: Fundación Cardioinfantil Instituto de Cardiología
name: Clínica Universidad de La Sabana
First posted: 2020-08-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Enrolled patients receive mechanical ventilation using the Unisabana-Herons ventilator during 24 hours
Primary purpose: DEVICE_FEASIBILITY

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.

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 effectiveness of ventilatory assistance in saving human lives was known since biblical times, the first mechanical ventilators only appeared in 1800 and it was in 1900 when the first positive pressure ventilators were manufactured, which have a turning point in 1940 as a result of the polio epidemic, when invasive positive pressure mechanical ventilators were developed that could be used massively and have evolved to current models. These positive pressure fans completely replaced the first negative pressure models, have abundant support in the scientific literature, and are the most commonly used today.

Since the beginning of the COVID-19 epidemic in Colombia, the University of La Sabana, a multidisciplinary team in order to find solutions to deal with the disease, and its first project, consisted in the design and manufacture of an invasive mechanical ventilator (Ventilator Unisabana-Herons) able to supply the basic ventilatory needs of the patient with severe respiratory failure due to COVID-19 at the time when the installed capacity of classic commercial mechanical ventilators is exhausted. The Unisabana-Herons ventilator was built based on those recommended by INVIMA, the MHRA (UK Medicines and Devices Regulatory Agency) and the FDA, to provide efficient and safe volume controlled ventilation to patients with indications. of mechanical ventilation for respiratory failure according to the ventilatory modes already affected that have strong scientific evidence.

This study seeks to evaluate the effectiveness, usability and safety of the Unisabana-Herons ventilator for the management of patients with an indication for invasive mechanical ventilatory support, admitted to level III and IV university hospitals with Intensive Care services enabled through a cohort study of 5 patients with a 24-hour follow-up.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Improvement or maintenance of the oxygenation level measured by PaO2
timeFrame: 24 hours
measure: Improvement or maintenance of the oxygenation level measured by O2 Saturation
timeFrame: 24 hours
Secondary outcomes:
measure: Improvement or maintenance of adequate levels of carbon dioxide measured by PaCO2
timeFrame: 24 hours
measure: Improvement or maintenance of adequate levels of HCO3
timeFrame: 24 hours
measure: Improvement or maintenance of adequate levels of excess base.
timeFrame: 24 hours
measure: Improvement or maintenance of adequate levels of blood pH
timeFrame: 24 hours
measure: Improvement or maintenance of PaO2/FiO2
timeFrame: 24 hours
measure: Improvement or maintenance of SatO2/FiO2
timeFrame: 24 hours
measure: Uninterrupted and faultless operation in the period of use of the ventilator
timeFrame: 24 hours
measure: Inspiratory peak pressure> 35 cm H2O that does not have a clinical explanation other than the ventilator (such as a mucus plug)
timeFrame: 24 hours
measure: Plateau airway pressure> 30 cm H2O that does not have a clinical explanation other than the ventilator
timeFrame: 24 hours
measure: VT> 8 cc / kg of ideal weight that does not have a clinical explanation other than the ventilator
timeFrame: 24 hours
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)
timeFrame: 24 hours
measure: Pneumothorax (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
timeFrame: 24 hours
measure: Pneumomediastinum (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
timeFrame: 24 hours
measure: Subcutaneous emphysema (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
timeFrame: 24 hours
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
timeFrame: 24 hours
measure: Cardiac arrest without a clinical explanation other than the ventilator
timeFrame: 24 hours
measure: Death without a clinical explanation other than the ventilator
timeFrame: 24 hours
measure: Elevation of creatinine that does not have a clinical explanation other than the ventilator
timeFrame: 24 hours
measure: Elevation of BUN that does not have a clinical explanation other than the ventilator
timeFrame: 24 hours
measure: Digestive bleeding without a clinical explanation other than ventilator
timeFrame: 24 hours
measure: Stress ulcers (upper gastrointestinal tract) without a clinical explanation other than ventilator
timeFrame: 24 hours
measure: Pneumonia associated with ventilator.
timeFrame: 24 hours
measure: Tracheobronchitis associated with ventilator.
timeFrame: 24 hours
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
timeFrame: 24 hours
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
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundacion Neumologica Colombiana
state: Bogota
city: Chia
country: Colombia
facility: Universidad de la Sabana
state: Cundinamarca
city: Chía
country: Colombia
facility: Clinica Universidad de la Sabana
state: Cundinamarca
Study officials:
affiliation: Fundación Neumológica Colombiana y Universidad de La Sabana
name: Luis F Giraldo-Cadavid, MD, PhD
role: STUDY_DIRECTOR
affiliation: Fundacion Neumologica Colombiana
name: Fabio A Varon-Vega, MD, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de la Sabana
name: Alirio R Bastidas, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.