Covid19SabanaHeronsNCT04497623
Clinical Evaluation of Ventilador Innovation Product in Colombia in the SARS COVID 19 Pandemic, Unisabana Herons.
A study testing Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours in people with Covid19, run by Fundación Neumologica Colombiana at 3 sites in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesColombia
- Study dates
- 28 Jul 2020to 20 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Colombia3 sites
Fundacion Neumologica Colombiana
Bogotá, Bogota D.C., 110131399
Clinica Universidad de la Sabana
Chía, Cundinamarca, 210001
Universidad de la Sabana
Chía, Cundinamarca, 250001
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours
- Keywords
- Mechanical ventilator, Covid 19, SARSCOV2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hoursDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients with indication for volume-controlled mechanical ventilation Receives: Device: Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours
Secondary outcomes (25)
Improvement or maintenance of adequate levels of carbon dioxide measured by PaCO2
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.
Measured: 24 hours
Improvement or maintenance of adequate levels of HCO3
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.
Measured: 24 hours
Improvement or maintenance of adequate levels of excess base.
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.
Measured: 24 hours
Improvement or maintenance of adequate levels of blood pH
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.
Measured: 24 hours
Improvement or maintenance of PaO2/FiO2
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.
Measured: 24 hours
Improvement or maintenance of SatO2/FiO2
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.
Measured: 24 hours
Uninterrupted and faultless operation in the period of use of the ventilator
Present or absent outcome
Measured: 24 hours
Inspiratory peak pressure> 35 cm H2O that does not have a clinical explanation other than the ventilator (such as a mucus plug)
Peak pressure >35 CM H20.
Measured: 24 hours
Plateau airway pressure> 30 cm H2O that does not have a clinical explanation other than the ventilator
Present or absent outcome
Measured: 24 hours
VT> 8 cc / kg of ideal weight that does not have a clinical explanation other than the ventilator
Present or absent outcome
Measured: 24 hours
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)
Present or absent outcome
Measured: 24 hours
Pneumothorax (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
Present or absent outcome
Measured: 24 hours
Pneumomediastinum (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
Present or absent outcome
Measured: 24 hours
Subcutaneous emphysema (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
Present or absent outcome
Measured: 24 hours
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
Present or absent outcome
Measured: 24 hours
Cardiac arrest without a clinical explanation other than the ventilator
Present or absent outcome
Measured: 24 hours
Death without a clinical explanation other than the ventilator
Present or absent outcome
Measured: 24 hours
Elevation of creatinine that does not have a clinical explanation other than the ventilator
Present or absent outcome
Measured: 24 hours
Elevation of BUN that does not have a clinical explanation other than the ventilator
Present or absent outcome
Measured: 24 hours
Digestive bleeding without a clinical explanation other than ventilator
Present or absent outcome
Measured: 24 hours
Stress ulcers (upper gastrointestinal tract) without a clinical explanation other than ventilator
Present or absent outcome
Measured: 24 hours
Pneumonia associated with ventilator.
Present or absent outcome
Measured: 24 hours
Tracheobronchitis associated with ventilator.
Present or absent outcome
Measured: 24 hours
Critical care polyneuropathy that does not have a different explanation for the use of the ventilator and / or muscle relaxants necessary for mechanical ventilation
Present or absent outcome
Measured: 24 hours
Critical care myopathy that does not have a different explanation for the use of the ventilator and / or muscle relaxants necessary for mechanical ventilation
Present or absent outcome
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start28 Jul 2020
- Primary completion13 Aug 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Enrolled patients receive mechanical ventilation using the Unisabana-Herons ventilator during 24 hours
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Neumologica Colombiana
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de la Sabana, Fundación Cardioinfantil Instituto de Cardiología, Clínica Universidad de La Sabana
- Responsible party
- Sponsor
- Investigators
- Luis F Giraldo-Cadavid, MD, PhD, Study director, Fundación Neumológica Colombiana y Universidad de La SabanaFabio A Varon-Vega, MD, PhD(c), Principal investigator, Fundacion Neumologica ColombianaAlirio R Bastidas, MD, MSc, Principal investigator, Universidad de la Sabana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497623
- Sponsor's protocol ID
- 202006-25502
- Acronym
- SabanaHerons
- Status last verified
- Sep 2020
- First submitted
- 27 Jul 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The clinical and ventilatory data of the patients will be entered into an anonymized database hosted on the RedCap platform with which the University of La Sabana has an agreement.
Publications
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.
PubMed 17636739ARDS 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.
PubMed 22797452Bellani 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.
PubMed 26903337Briel 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.
PubMed 20197533Meade 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.
PubMed 18270352Giraldo-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.
PubMed 38756610
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Ventilator Innovation Product in Colombia in the SARS Pandemic Covid 19, Unisabana Herons - A Cohort Study - Phase 1
- ClinicalTrials.gov ID
- NCT04497623
- Acronym / sponsor ID
- SabanaHerons / 202006-25502
- Conditions
- Covid19
- Keywords
- Mechanical ventilator, Covid 19, SARSCOV2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fundación Neumologica ColombianaUniversity, hospital or other
- Collaborators
- Universidad de la Sabana, Fundación Cardioinfantil Instituto de Cardiología, Clínica Universidad de La Sabana
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled patients receive mechanical ventilation using the Unisabana-Herons ventilator during 24 hours
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hoursPatients with indication for volume-controlled mechanical ventilation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hoursRecruited 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. | Device | Intervention arm |
Primary outcome
Improvement or maintenance of the oxygenation level measured by PaO2
Time frame: 24 hours
Maintenance: less than 20% drop in PaO2 with respect to the baseline measurements made in the 30 minutes before connecting the Unisabana-Herons ventilator.
Improvement or maintenance of the oxygenation level measured by O2 Saturation
Time frame: 24 hours
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.
25 secondary outcomes
Improvement or maintenance of adequate levels of carbon dioxide measured by PaCO2
Time frame: 24 hours
Improvement or maintenance of adequate levels of HCO3
Time frame: 24 hours
Improvement or maintenance of adequate levels of excess base.
Time frame: 24 hours
Improvement or maintenance of adequate levels of blood pH
Time frame: 24 hours
Improvement or maintenance of PaO2/FiO2
Time frame: 24 hours
Improvement or maintenance of SatO2/FiO2
Time frame: 24 hours
Uninterrupted and faultless operation in the period of use of the ventilator
Time frame: 24 hours
Inspiratory peak pressure> 35 cm H2O that does not have a clinical explanation other than the ventilator (such as a mucus plug)
Time frame: 24 hours
Plateau airway pressure> 30 cm H2O that does not have a clinical explanation other than the ventilator
Time frame: 24 hours
VT> 8 cc / kg of ideal weight that does not have a clinical explanation other than the ventilator
Time frame: 24 hours
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 frame: 24 hours
Pneumothorax (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
Time frame: 24 hours
Pneumomediastinum (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
Time frame: 24 hours
Subcutaneous emphysema (not having an explanation other than ventilatory support, such as the insertion of a central catheter)
Time frame: 24 hours
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 frame: 24 hours
Cardiac arrest without a clinical explanation other than the ventilator
Time frame: 24 hours
Death without a clinical explanation other than the ventilator
Time frame: 24 hours
Elevation of creatinine that does not have a clinical explanation other than the ventilator
Time frame: 24 hours
Elevation of BUN that does not have a clinical explanation other than the ventilator
Time frame: 24 hours
Digestive bleeding without a clinical explanation other than ventilator
Time frame: 24 hours
Stress ulcers (upper gastrointestinal tract) without a clinical explanation other than ventilator
Time frame: 24 hours
Pneumonia associated with ventilator.
Time frame: 24 hours
Tracheobronchitis associated with ventilator.
Time frame: 24 hours
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 frame: 24 hours
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 frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Background: PubMed 17636739Petrucci 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.
- Background: PubMed 22797452ARDS 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.
- Background: PubMed 26903337Bellani 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.
- Background: PubMed 20197533Briel 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.
- Background: PubMed 18270352Meade 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.
- Derived from this study: PubMed 38756610Giraldo-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.
- Individual participant dataSharing planned: No. The clinical and ventilatory data of the patients will be entered into an anonymized database hosted on the RedCap platform with which the University of La Sabana has an agreement.
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COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis F Giraldo-Cadavid, MD, PhD study director
Fundación Neumológica Colombiana y Universidad de La Sabana
Fabio A Varon-Vega, MD, PhD(c) principal investigator
Fundacion Neumologica Colombiana
Alirio R Bastidas, MD, MSc principal investigator
Universidad de la Sabana
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours in people with Covid19, run by Fundación Neumologica Colombiana at 3 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement or maintenance of the oxygenation level measured by PaO2 (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04497623, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.