ARDSVILIVORTEXNCT04174313
Ventilator-induced Lung Injury Vortex in Patients With SARS-CoV-2
An observational study of ARDS and Mechanical Ventilation Complication, run by Hospital El Cruce at 1 site in Argentina.
Trial summary
The concept of Ventilator-induced Lung Injury Vortex (VILI vortex) has recently been proposed as a progressive lung injury mechanism in which the alveolar stress/strain increases as the ventilable lung "shrinks" (1). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
- What is being tested?
- CT scan
- How many people
- 65 participants
- Where
- 1 siteArgentina
- Study dates
- 10 Mar 2020to 9 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with SARS-CoV-2 in mechanical ventilation
Who may be able to join
- -
Who cannot join
- Patients with do-not-resuscitate (DNR) orders and pregnant women. Cardiac arrest before ICU admission. Extra corporeal membrane oxygenation (ECMO) requirement within the first 24 h of ICU admission and chronic obstructive pulmonary disease with gold class 3 or 4, or home oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
The concept of Ventilator-induced Lung Injury Vortex (VILI vortex) has recently been proposed as a progressive lung injury mechanism in which the alveolar stress/strain increases as the ventilable lung "shrinks" (1). This positive feedback inexorably leads to the acceleration of lung damage, with potentially irreversible results. Little is known about the clinical aspects of this condition. Understanding its behavior could contribute to changing its potential devastating impact.
The objective of this study is to evaluate the incidence of VILI vortex in patients with acute respiratory syndrome (ARDS) secondary to COVID-19, to establish a connection between this phenomenon and mortality, and to identify the factors that have an impact on its development.
Read the detailed description
Mechanical ventilation is an essential tool for the treatment of patients with acute respiratory distress syndrome (ARDS). However, as with other strategies, it is not free of complications. Inadequate ventilation may have a negative impact on pulmonary and systemic hemodynamics, and it could both cause structural damage to pulmonary parenchyma and activate inflammation (2). This process is known as ventilator-induced lung injury (VILI) and may promote the development of multiple organ failure and, eventually, death.
VILI results from the interaction between the mechanical load applied to the ventilable lung and its capacity to tolerate it. Factors such as tidal volume (Vt), driving pressure (ΔP), inspiratory flow rate (VI), respiratory rate (RR), excessive inspiratory effort, high levels of FiO2 and, in some cases, PEEP, have been involved in damage mechanism. In that sense, the concept of mechanical power (MP) tries to encompass most of these factors within a measurable unit (3). Furthermore, the decrease in ventilable lung volume (baby lung concept), the heterogeneous lung compromise in ARDS), and the presence of cofactors that have a negative impact on the lung (fluid overload, presence of sepsis or shock) could increase its susceptibility to damage (4-5).
Due to the fact that the mechanical conditions of the lung change dynamically with the progression of the disease, the ventilatory strategy needs constant adjustments in order to maintain a balance between the load and the size of the ventilable lung (concept of ergonomic ventilation). In fact, a protective ventilatory strategy of low tidal volume (Vt: 6 ml/kg/PBW) and limited plateau pressure (PPlat <30 cmH2O) may cause damage if the functional residual capacity (FRC) decreases significantly, thus making a lower number of alveoli (including capillaries) withstand a higher mechanical load per unit.
The concept of VILI vortex has recently been proposed as a progressive lung injury mechanism in which the alveolar stress/strain increases as the ventilable lung "shrinks". This positive feedback inexorably leads to the acceleration of lung damage, with potentially irreversible results (1). Little is known about the clinical aspects of this condition. Understanding its behavior could contribute to changing its potential devastating impact.
The objective of this study is to evaluate the incidence of VILI vortex in patients with ARDS secondary to COVID-19, to establish a connection between this phenomenon and mortality, and to identify the factors that have an impact on its development.
- Being tested
- CT scan
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Also called Transpulmonary pressures (TP) will be measured
Mechanical variables and PaO2/FiO2 were registered daily for 14 days or until initiating assisted ventilation. These data were obtained in passive mechanical conditions.
Ventilator-induced lung injury vortex was defined as a progressive increase in driving pressure (ΔP) as Vt remained constant or even decreased.
Refractory hypoxemia was defined as PaO2/FiO2 <100 despite the optimization of mechanical ventilation and prone positioning.
| Study group | Role | What they receive |
|---|---|---|
| VILI VORTEX and No VILI VORTEX | Measurement of pulmonary pressures and volumes in the same patient Receives: Diagnostic Test: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Survived and Died
The number of patients who died and survived was compared between patients with SARS-CoV-2 who progressed with VILI VORTEX and without VILI VORTEX)
Measured: 90 days
Number of Patients With and Without Refractory Hypoxemia
The number of patients that evolved with refractory hypoxemia was compared between the patients with SARS-CoV-2 that evolved with VILI VORTEX and without VILI VORTEX) Refractory hypoxemia was defined as PaO2/FiO2 <100 despite the optimization of mechanical ventilation and prone positioning.
Measured: 90 days
Number of Patients With Complications
The following variables and complications were also observed during the period of analysis: incidence of pneumonia associated with mechanical ventilation, need for noradrenaline over 0.1 γ/kg/min for more than 24 h, positive blood cultures, accumulated fluid balance, dialysis treatment, clinical and/or echocardiographic evidence of heart failure, lactate ≥2 mmol/L in at least two consecutive samples, presence of persistent fever (≥38º at least once a day for three consecutive days), and the highest value of ferritin, D-dimer, C-reactive protein, troponin I and LDH obtained during the first 14 days of invasive mechanical ventilation.
VILI vortex patients had positive blood cultures, moderate to severe shock, persistent fever and fluid balance was considerably more positive.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start10 Mar 2020
- Primary completion11 Mar 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor Pistillo, Hospital El Cruce
- Investigators
- Nestor Pistillo, Principal investigator, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174313
- Sponsor's protocol ID
- Nestor Pistillo
- Acronym
- VILIVORTEX
- Status last verified
- Aug 2021
- First submitted
- 20 Nov 2019
- Last updated
- 30 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marini JJ, Gattinoni L. Time Course of Evolving Ventilator-Induced Lung Injury: The "Shrinking Baby Lung". Crit Care Med. 2020 Aug;48(8):1203-1209. doi: 10.1097/CCM.0000000000004416.
PubMed 32697492Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14.
PubMed 27842744Gattinoni L, Pesenti A. The concept of "baby lung". Intensive Care Med. 2005 Jun;31(6):776-84. doi: 10.1007/s00134-005-2627-z. Epub 2005 Apr 6.
PubMed 15812622Gattinoni L, Tonetti T, Quintel M. Regional physiology of ARDS. Crit Care. 2017 Dec 28;21(Suppl 3):312. doi: 10.1186/s13054-017-1905-9.
PubMed 29297365Vasques F, Duscio E, Cipulli F, Romitti F, Quintel M, Gattinoni L. Determinants and Prevention of Ventilator-Induced Lung Injury. Crit Care Clin. 2018 Jul;34(3):343-356. doi: 10.1016/j.ccc.2018.03.004.
PubMed 29907269
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator-induced Lung Injury Vortex in Patients With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04174313
- Acronym / sponsor ID
- VILIVORTEX / Nestor Pistillo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Posted 30 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The concept of Ventilator-induced Lung Injury Vortex (VILI vortex) has recently been proposed as a progressive lung injury mechanism in which the alveolar stress/strain increases as the ventilable lung "shrinks" (1). This positive feedback inexorably leads to the acceleration of lung damage, with potentially irreversible results. Little is known about the clinical aspects of this condition. Understanding its behavior could contribute to changing its potential devastating impact.
The objective of this study is to evaluate the incidence of VILI vortex in patients with acute respiratory syndrome (ARDS) secondary to COVID-19, to establish a connection between this phenomenon and mortality, and to identify the factors that have an impact on its development.
Detailed description
Mechanical ventilation is an essential tool for the treatment of patients with acute respiratory distress syndrome (ARDS). However, as with other strategies, it is not free of complications. Inadequate ventilation may have a negative impact on pulmonary and systemic hemodynamics, and it could both cause structural damage to pulmonary parenchyma and activate inflammation (2). This process is known as ventilator-induced lung injury (VILI) and may promote the development of multiple organ failure and, eventually, death.
VILI results from the interaction between the mechanical load applied to the ventilable lung and its capacity to tolerate it. Factors such as tidal volume (Vt), driving pressure (ΔP), inspiratory flow rate (VI), respiratory rate (RR), excessive inspiratory effort, high levels of FiO2 and, in some cases, PEEP, have been involved in damage mechanism. In that sense, the concept of mechanical power (MP) tries to encompass most of these factors within a measurable unit (3). Furthermore, the decrease in ventilable lung volume (baby lung concept), the heterogeneous lung compromise in ARDS), and the presence of cofactors that have a negative impact on the lung (fluid overload, presence of sepsis or shock) could increase its susceptibility to damage (4-5).
Due to the fact that the mechanical conditions of the lung change dynamically with the progression of the disease, the ventilatory strategy needs constant adjustments in order to maintain a balance between the load and the size of the ventilable lung (concept of ergonomic ventilation). In fact, a protective ventilatory strategy of low tidal volume (Vt: 6 ml/kg/PBW) and limited plateau pressure (PPlat <30 cmH2O) may cause damage if the functional residual capacity (FRC) decreases significantly, thus making a lower number of alveoli (including capillaries) withstand a higher mechanical load per unit.
The concept of VILI vortex has recently been proposed as a progressive lung injury mechanism in which the alveolar stress/strain increases as the ventilable lung "shrinks". This positive feedback inexorably leads to the acceleration of lung damage, with potentially irreversible results (1). Little is known about the clinical aspects of this condition. Understanding its behavior could contribute to changing its potential devastating impact.
The objective of this study is to evaluate the incidence of VILI vortex in patients with ARDS secondary to COVID-19, to establish a connection between this phenomenon and mortality, and to identify the factors that have an impact on its development.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VILI VORTEX and No VILI VORTEX | – | Diagnostic Test: CT scanMeasurement of pulmonary pressures and volumes in the same patient |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SARS-CoV-2 in mechanical ventilation
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Patients with do-not-resuscitate (DNR) orders and pregnant women. Cardiac arrest before ICU admission. Extra corporeal membrane oxygenation (ECMO) requirement within the first 24 h of ICU admission and chronic obstructive pulmonary disease with gold class 3 or 4, or home oxygen therapy
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 |
|---|---|---|
| CT scanAlso: Transpulmonary pressures (TP) will be measuredMechanical variables and PaO2/FiO2 were registered daily for 14 days or until initiating assisted ventilation. These data were obtained in passive mechanical conditions. Ventilator-induced lung injury vortex was defined as a progressive increase in driving pressure (ΔP) as Vt remained constant or even decreased. Refractory hypoxemia was defined as PaO2/FiO2 <100 despite the optimization of mechanical ventilation and prone positioning. | Diagnostic test | VILI VORTEX and No VILI VORTEX |
Primary outcome
Number of Participants Who Survived and Died
Time frame: 90 days
The number of patients who died and survived was compared between patients with SARS-CoV-2 who progressed with VILI VORTEX and without VILI VORTEX)
Number of Patients With and Without Refractory Hypoxemia
Time frame: 90 days
The number of patients that evolved with refractory hypoxemia was compared between the patients with SARS-CoV-2 that evolved with VILI VORTEX and without VILI VORTEX) Refractory hypoxemia was defined as PaO2/FiO2 <100 despite the optimization of mechanical ventilation and prone positioning.
Number of Patients With Complications
Time frame: 90 days
The following variables and complications were also observed during the period of analysis: incidence of pneumonia associated with mechanical ventilation, need for noradrenaline over 0.1 γ/kg/min for more than 24 h, positive blood cultures, accumulated fluid balance, dialysis treatment, clinical and/or echocardiographic evidence of heart failure, lactate ≥2 mmol/L in at least two consecutive samples, presence of persistent fever (≥38º at least once a day for three consecutive days), and the highest value of ferritin, D-dimer, C-reactive protein, troponin I and LDH obtained during the first 14 days of invasive mechanical ventilation. VILI vortex patients had positive blood cultures, moderate to severe shock, persistent fever and fluid balance was considerably more positive.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32697492Marini JJ, Gattinoni L. Time Course of Evolving Ventilator-Induced Lung Injury: The "Shrinking Baby Lung". Crit Care Med. 2020 Aug;48(8):1203-1209. doi: 10.1097/CCM.0000000000004416.
- Background: PubMed 27842744Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14.
- Background: PubMed 15812622Gattinoni L, Pesenti A. The concept of "baby lung". Intensive Care Med. 2005 Jun;31(6):776-84. doi: 10.1007/s00134-005-2627-z. Epub 2005 Apr 6.
- Background: PubMed 29297365Gattinoni L, Tonetti T, Quintel M. Regional physiology of ARDS. Crit Care. 2017 Dec 28;21(Suppl 3):312. doi: 10.1186/s13054-017-1905-9.
- Background: PubMed 29907269Vasques F, Duscio E, Cipulli F, Romitti F, Quintel M, Gattinoni L. Determinants and Prevention of Ventilator-Induced Lung Injury. Crit Care Clin. 2018 Jul;34(3):343-356. doi: 10.1016/j.ccc.2018.03.004.
- Individual participant dataSharing planned: No
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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.
Nestor Pistillo principal investigator
Hospital El Cruce
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and Mechanical Ventilation Complication, run by Hospital El Cruce at 1 site in Argentina.
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 1 inclusion and 1 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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Survived and Died (time frame: 90 days). The study lists 3 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 NCT04174313, which also lists 5 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 30 Aug 2021.