ARDSNCT04694742
Ventilatory Efficiency in Critically Ill COVID-19 Patients
An observational study of ARDS, run by ASST Fatebenefratelli Sacco at 4 sites in Italy.
Trial summary
The new severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2) causes the illness named COVID-19, which is primarily characterized by pneumonia. As of 27 December, there have been over 79.2 million cases and over 1.7 million deaths reported since the start of the pandemic. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ARDS
- What is being tested?
- data collecting
- How many people
- 100 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Sep 2020to 15 Apr 2021
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients consecutively admitted to ICU with the eligibility criteria will be enrolled in the study. They will be treated according to the standard of care.
Who may be able to join
- All of the following:
- confirmed SARS-CoV-2 infection by RT-PCR on a nasopharyngeal swab
- severe hypoxemia due to COVID-19 who meets the diagnostic criteria of ARDS (Berlin's definition)
- invasive mechanical ventilation
- patients receiving neuromuscular blocking drugs
Who cannot join
- history of preexisting severe hypoxemia (i.e. primary pulmonary hypertension, COPD in therapy with O2 supplementation, pulmonary fibrosis, etc.)
- severe haemodynamic instability defined as:
- Mean arterial pressure < 65 mmHg despite the infusion of norepinephrine, or epinephrine, or dobutamine, or levosimendan
- severe left ventricular dysfunction with ejection fraction <20%
- right ventricular failure due to pulmonary embolism
Trial locations and contacts
4 sites in 1 country.
Andrea Agarossi, M.D. contact
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, The Marches, 60126
Andrea Carsetti, M.D., a.carsetti@staff.univpm.it
Andrea Carsetti, M.D.
- Not yet recruiting
Arcispedale Sant'Anna
Ferrara, Emilia-Romagna, 44124
Alberto Fogagnolo, M.D., alberto.fogagnolo@gmail.com
Alberto Fogagnolo, M.D.
- Recruiting
ASST Fatebenefratelli Sacco
Milan, Lombardy, 20157
Riccardo Colombo, M.D., 0239043023, riccardo.colombo@asst-fbf-sacco.it
Riccardo Colombo, M.D.
- Not yet recruiting
Ospedale Infermi
Rimini, Emilia-Romagna, 47923
Jonathan Montomoli, M.D., jonathan.montomoli@gmail.com
Jonathan Montomoli, M.D.
About this study
The new severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2) causes the illness named COVID-19, which is primarily characterized by pneumonia. As of 27 December, there have been over 79.2 million cases and over 1.7 million deaths reported since the start of the pandemic. In many cases, pneumonia evolves to acute respiratory distress syndrome (ARDS) with the need for mechanical ventilation and patient admission to intensive care unit, determining a marked increase in the need for intensive care beds worldwide.
Pulmonary involvement causes predominantly hypoxemic respiratory failure. Although COVID-19 pneumonia often falls within the diagnostic criteria of ARDS, it differs from it for some peculiar pathophysiological characteristics. In particular, patients with ARDS secondary to COVID-19 often have the compliance of the respiratory system within the normal range. A significant role in the pathophysiology of hypoxemia seems to depend on vascular alterations such as altered pulmonary vascular self-regulation, pulmonary capillary leakage, and microvascular thrombosis in a complex process known as "immunothrombosis". All together they act by altering the relationship between ventilation and perfusion and increasing the dead space, which ultimately results in impaired efficiency of the pulmonary ventilation. Among the various markers associated with the prognosis of patients with COVID-19, D-dimer is linked to both the inflammatory state and thrombotic phenomena and could help to identify patients at greater risk of developing early ventilation-perfusion changes.
This study aims at measuring the ventilatory efficiency, assessed by Ventilatory Ratio, in critically ill, mechanically ventilated, COVID-19 patients and its correlation with plasma D-dimer and quasi-static respiratory compliance.
- Conditions
- ARDS
- Being tested
- data collecting
- Keywords
- Ventilatory ratio, Mechanical ventilation, ARDS, COVID-19, Critical illness, Dead-space
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectingOther
Within 24h from ICU admission, the ventilatory efficiency will be assessed by the following Ventilatory Ratio equation:
Ventilatory Ratio = [minute ventilation (ml/min) × PaCO2 (mm Hg)]/(predicted body weight × 100 × 37.5).
Where PaCO2 is the partial pressure of carbon dioxide in mmHg in the arterial blood.
Tha quasi-static compliance will be calculated according to the equation:
C=Tidal Volume/(Paw plateau - PEEP total)
where Paw plateau is the airway pressure measured during 4 seconds of inspiratory pause, PEEP total is the airway pressure measured during 4 seconds of expiratory pause.
In the same time frame, complete blood count, d-dimer, sequential organ failure assessment score, blood gas analysis, haemodynamic and ventilatory parameters will be collected.
| Study group | Role | What they receive |
|---|---|---|
| ARDS COVID-19 | Patients who meet Berlin's ARDS diagnostic criteria, with confirmed SARS-CoV-2 infection, requiring invasive mechanical ventilation. Receives: Other: data collecting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory ratio correlation
Measure the correlation between ventilatory ratio, plasma D-dimer, and quasi-static compliance of the respiratory system
Measured: 24 hours from ICU admission
Secondary outcomes (1)
Mortality
Mortality among subgroups stratified according to Ventilatory ratio and quasi-static respiratory compliance. Subgroup will be identified according centiles of the distribution values of 1) Ventilatory Ratio, and 2) quasi-static compliance both measured in the first 24 hours.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Sep 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Infermi Rimini, S. Anna Hospital, Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Responsible party
- Principal investigator, Riccardo Colombo, ASST Fatebenefratelli Sacco
- Investigators
- Riccardo Colombo, M.D., Principal investigator, ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694742
- Sponsor's protocol ID
- VentRatio-19
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2021
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
WHO Weekly epidemiological update - 29 December 2020 - https://www.who.int/publications/m/item/weekly-epidemiological-update---29-december-2020
Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC.
PubMed 30211618ARDS 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 22797452
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Efficiency in Critically Ill COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04694742
- Acronym / sponsor ID
- VentRatio-19
- Conditions
- ARDS
- Keywords
- Ventilatory ratio, Mechanical ventilation, ARDS, COVID-19, Critical illness, Dead-space
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Collaborators
- Ospedale Infermi Rimini, S. Anna Hospital, Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 5 Jan 2021 (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 new severe acute respiratory syndrome coronavirus 2019 (SARS-CoV-2) causes the illness named COVID-19, which is primarily characterized by pneumonia. As of 27 December, there have been over 79.2 million cases and over 1.7 million deaths reported since the start of the pandemic. In many cases, pneumonia evolves to acute respiratory distress syndrome (ARDS) with the need for mechanical ventilation and patient admission to intensive care unit, determining a marked increase in the need for intensive care beds worldwide.
Pulmonary involvement causes predominantly hypoxemic respiratory failure. Although COVID-19 pneumonia often falls within the diagnostic criteria of ARDS, it differs from it for some peculiar pathophysiological characteristics. In particular, patients with ARDS secondary to COVID-19 often have the compliance of the respiratory system within the normal range. A significant role in the pathophysiology of hypoxemia seems to depend on vascular alterations such as altered pulmonary vascular self-regulation, pulmonary capillary leakage, and microvascular thrombosis in a complex process known as "immunothrombosis". All together they act by altering the relationship between ventilation and perfusion and increasing the dead space, which ultimately results in impaired efficiency of the pulmonary ventilation. Among the various markers associated with the prognosis of patients with COVID-19, D-dimer is linked to both the inflammatory state and thrombotic phenomena and could help to identify patients at greater risk of developing early ventilation-perfusion changes.
This study aims at measuring the ventilatory efficiency, assessed by Ventilatory Ratio, in critically ill, mechanically ventilated, COVID-19 patients and its correlation with plasma D-dimer and quasi-static respiratory compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS COVID-19 | – | Other: data collectingPatients who meet Berlin's ARDS diagnostic criteria, with confirmed SARS-CoV-2 infection, requiring invasive mechanical ventilation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients consecutively admitted to ICU with the eligibility criteria will be enrolled in the study. They will be treated according to the standard of care.
Key inclusion criteria (5 listed)
- confirmed SARS-CoV-2 infection by RT-PCR on a nasopharyngeal swab
- severe hypoxemia due to COVID-19 who meets the diagnostic criteria of ARDS (Berlin's definition)
- invasive mechanical ventilation
- patients receiving neuromuscular blocking drugs
Key exclusion criteria (5 listed)
- history of preexisting severe hypoxemia (i.e. primary pulmonary hypertension, COPD in therapy with O2 supplementation, pulmonary fibrosis, etc.)
- severe haemodynamic instability defined as:
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 |
|---|---|---|
| data collectingWithin 24h from ICU admission, the ventilatory efficiency will be assessed by the following Ventilatory Ratio equation: Ventilatory Ratio = [minute ventilation (ml/min) × PaCO2 (mm Hg)]/(predicted body weight × 100 × 37.5). Where PaCO2 is the partial pressure of carbon dioxide in mmHg in the arterial blood. Tha quasi-static compliance will be calculated according to the equation: C=Tidal Volume/(Paw plateau - PEEP total) where Paw plateau is the airway pressure measured during 4 seconds of inspiratory pause, PEEP total is the airway pressure measured during 4 seconds of expiratory pause. In the same time frame, complete blood count, d-dimer, sequential organ failure assessment score, blood gas analysis, haemodynamic and ventilatory parameters will be collected. | Other | ARDS COVID-19 |
Primary outcome
Ventilatory ratio correlation
Time frame: 24 hours from ICU admission
Measure the correlation between ventilatory ratio, plasma D-dimer, and quasi-static compliance of the respiratory system
1 secondary outcome
Mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- BackgroundWHO Weekly epidemiological update - 29 December 2020 - https://www.who.int/publications/m/item/weekly-epidemiological-update---29-december-2020
- Background: PubMed 30211618Sinha P, Calfee CS, Beitler JR, Soni N, Ho K, Matthay MA, Kallet RH. Physiologic Analysis and Clinical Performance of the Ventilatory Ratio in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2019 Feb 1;199(3):333-341. doi: 10.1164/rccm.201804-0692OC.
- 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.
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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.
Andrea Agarossi, M.D. contact
Riccardo Colombo, M.D. principal investigator
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, run by ASST Fatebenefratelli Sacco at 4 sites in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Colombo, M.D. (+390239043023, riccardo.colombo@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory ratio correlation (time frame: 24 hours from ICU admission). 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 NCT04694742, which also lists 3 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 5 Jan 2021.