Respiratory Distress SyndromeCOVENNCT04497454
Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19)
A study testing EIT-Group and ARDSNet in people with Respiratory Distress Syndrome and Mechanical Ventilation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Mechanical Ventilation, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- EIT-Group and ARDSNet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBrazil
- Study dates
- 8 May 2020to 1 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under mechanical ventilation with ARDS (Berlin definition) caused by SARS-COV2 infection:
- ARDS diagnosis in less than 24 hours
- Respiratory System Compliance of 0.6 mL/cmH2O/Kg of PBW
Who cannot join
- Age < 18 years
- Active bronchopleural fistula
- History of chronic and disabling respirator disease, requiring home oxygen treatment
- Chronic pulmonary arterial hypertension (pulmonary artery systolic pressure > 40 mmHg)
- Huge intrathoracic tumoral mass
- Electrical impedance tomography monitoring contraindications (as thoracic wounds or burns, electronic implantable devices)
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- Hemodynamic instability (systolic pressure < 80 mmHg or mean arterial pressure < 60 mmHg, despite vasopressor drugs; and/or heart rate < 55bpm) - this patient may be included after recovered from hemodynamic instability
- Not drained pneumothorax or subcutaneous emphysema or bronchopleural fistula
- Patients at risk of intracranial hypertension development or post Cardiopulmonary resuscitation (first 72 hours)
- Pregnancy
- Impossibility of monitoring with EIT
- Not committed to full support or life expectation < 24 hours
- Legal responsible or clinical team refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
USP Instituto do Coração
São Paulo, 05.403-010
Eduardo LV Costa, +551130667361, eduardoleitecosta@gmail.com
Maria AM Nakamura, +551130667151, mamiyukinakamura@gmail.com
About this study
Official title: Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19) - COVEN Study
This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.
Read the detailed description
Mechanical ventilatory strategy of the ARDS Network low PEEP-FiO2 table will be followed in the control arm. This strategy consists of at least 12 hours of controlled mechanical ventilation following prespecified PEEP and FiO2 combinations chosen dynamically targeting oxygenation. Tidal volume is set at 4-6 mL/Kg of predicted body weight (PBW) and plateau pressure is kept below 30 centimeters of water (cmH2O). Respiratory rate can be as high as 35 breaths per minute titrated to a potential of hydrogen (pH) 7.30-7.45. As oxygenation improves, patients are transitioned to assisted ventilation and then to pressure support ventilation until they are ready to be liberated from the ventilator. During this phase, no attempt is made to control plateau pressures or tidal volumes. In the intervention arm, minimizing tidal lung strain by keeping driving pressure below 16 cmH2O throughout the mechanical ventilation period will be targeted. The controlled phase will last at least 48 hours. PEEP will be selected according to a PEEP titration maneuver with EIT at the start of the intervention. This PEEP level will be kept until extubation. Respiratory rate can be as high as 50 breaths per minute targeting a pH of 7.15-7.45.
- Conditions
- Respiratory Distress Syndrome, Mechanical Ventilation, SARS (Severe Acute Respiratory Syndrome)
- Being tested
- EIT-Group, ARDSNet
- Medical subject headings
- Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT-GroupOther
A mechanical ventilation strategy with the main goal to maintain DP < 16 cmH2O
ARDSNetOther
Low PEEP-FiO2 table ARDS Network ventilation protocol
| Study group | Role | What they receive |
|---|---|---|
| ARDSNet | Active comparator | ARDSNet protocol (low PEEP-FiO2 table). Ventilatory mode: volume-controlled ventilation Tidal volume (VT) will be adjusted to 4-6 mL/Kg of PBW and Plateau pressure < 30 cmH2O for the at least the first 12 hours after inclusion in the protocol pH should be maintained between 7.35-7.45 Oxygenation (SpO2) target ranges 90-95% Maximum respiratory rate = 35 breaths/min PEEP and FIO2 adjusted according to the low PEEP-FiO2 Table. Receives: Other: ARDSNet |
| EIT-Group | Experimental | The goal is to maintain driving pressure (DP) < 16 cmH2O. Ventilatory mode: pressure-controlled ventilation After a recruitment a maneuver, PEEP will be chosen according to a PEEP titration maneuver monitored with electrical impedance tomography Plateau pressure may exceed 30 cmH2O and VT may exceed 6 mL/Kg if DP < 16 cmH2O pH should be maintained between 7.15-7.40 Oxygenation (SpO2) target ranges 90 -95% Maximum respiratory rate = 50 bpm Receives: Other: EIT-Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily Modified Lung injury score until day 28
This score originally ranges from 0 to 4 points based on the average of 4 parameters (PaO2/FiO2, chest X-Ray, PEEP level, and Respiratory compliance). In the modified version, if the patient dies, he or she automatically receives a score of 5 irrespective of the other four parameters. If the patient is extubated, the score is automatically zero. We also substituted FiO2 for PEEP guaranteeing equivalence of the score when either the low or high PEEP-FiO2 table is applied.
Measured: daily
Secondary outcomes (5)
High oxygen dependence free days until day 28
Number of days with less than or equal to 1 Liter/min of oxygen supplementation until day 28
Measured: 28 days
Mechanical ventilation free days until day 28
Number of days free of mechanical ventilation assistance after protocol inclusion and before day 28
Measured: 28 days
Incidence of shock or barotrauma
Occurrence of shock (persistent hypotension despite rescue measures) and incidence of barotrauma
Measured: 28 days
Incidence of acute renal failure requiring renal replacement therapy
Occurrence of acute renal failure that justifies renal replacement therapy
Measured: 28 days
28-day mortality
Percentage of patients who died in each arm up to 28 days
Measured: 28 days
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 start8 May 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2022 (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 Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, single-center, open-label, superiority, controlled trial
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute
- Responsible party
- Sponsor
- Investigators
- Eduardo LV Costa, PhD, Principal investigator, Hospital das Clinicas from University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497454
- Sponsor's protocol ID
- CAAE: 30938720800000068
- Acronym
- COVEN
- Status last verified
- May 2022
- First submitted
- 31 Jul 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alcala GC, Ekkapat G, Medeiros KJ, Morais CCA, Xin Y, Giammatteo V, Bruno G, Nova A, Wanderley H, Buhl T, Victor M, Gaulton TG, La Vita CJ, Amato MBP, Ceradda M, Berra L, Ribeiro De Santis Santiago R. Monitoring Lung Function with Electrical Impedance Tomography in the Intensive Care Unit. J Vis Exp. 2024 Sep 6;(211). doi: 10.3791/66756.
PubMed 39311582Costa ELV, Alcala GC, Tucci MR, Goligher E, Morais CC, Dianti J, Nakamura MAP, Oliveira LB, Pereira SM, Toufen C Jr, Barbas CSV, Carvalho CRR, Amato MBP. Impact of extended lung protection during mechanical ventilation on lung recovery in patients with COVID-19 ARDS: a phase II randomized controlled trial. Ann Intensive Care. 2024 Jun 8;14(1):85. doi: 10.1186/s13613-024-01297-z.
PubMed 38849605Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077.
PubMed 35767435
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation Strategy for Coronavirus Disease 2019 (COVID-19) - COVEN Study
- ClinicalTrials.gov ID
- NCT04497454
- Acronym / sponsor ID
- COVEN / CAAE: 30938720800000068
- Conditions
- Respiratory Distress Syndrome, Mechanical Ventilation, SARS (Severe Acute Respiratory Syndrome)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- InCor Heart Institute
- Study start
- 8 May 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- 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.
This is a prospective, randomized, single-center, open-label controlled trial, designed to compare the efficacy of two ventilation strategies (Low Tidal Volume and positive end-expiratory pressure (PEEP) based on the Acute Respiratory Distress Syndrome (ARDS) Network low PEEP-fraction of inspired oxygen inspired oxygen fraction (FIO2) Table versus Low Driving Pressure and PEEP guided by Electrical Impedance Tomography (EIT) in reducing daily lung injury score in patients with acute respiratory distress syndrome caused by COVID-19. The two strategies incorporate different prioritizations of clinical variables. The PEEP-FIO2 table strategy aims to reduce lung overdistension, even if it requires tolerating worse gas exchange. EIT-guided strategy prioritizes mechanical stress protection, avoiding alveolar overdistension and collapse.
Detailed description
Mechanical ventilatory strategy of the ARDS Network low PEEP-FiO2 table will be followed in the control arm. This strategy consists of at least 12 hours of controlled mechanical ventilation following prespecified PEEP and FiO2 combinations chosen dynamically targeting oxygenation. Tidal volume is set at 4-6 mL/Kg of predicted body weight (PBW) and plateau pressure is kept below 30 centimeters of water (cmH2O). Respiratory rate can be as high as 35 breaths per minute titrated to a potential of hydrogen (pH) 7.30-7.45. As oxygenation improves, patients are transitioned to assisted ventilation and then to pressure support ventilation until they are ready to be liberated from the ventilator. During this phase, no attempt is made to control plateau pressures or tidal volumes. In the intervention arm, minimizing tidal lung strain by keeping driving pressure below 16 cmH2O throughout the mechanical ventilation period will be targeted. The controlled phase will last at least 48 hours. PEEP will be selected according to a PEEP titration maneuver with EIT at the start of the intervention. This PEEP level will be kept until extubation. Respiratory rate can be as high as 50 breaths per minute targeting a pH of 7.15-7.45.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, single-center, open-label, superiority, controlled trial
| Arm | Type | Receives |
|---|---|---|
| ARDSNet | Active comparator | Other: ARDSNetARDSNet protocol (low PEEP-FiO2 table). Ventilatory mode: volume-controlled ventilation Tidal volume (VT) will be adjusted to 4-6 mL/Kg of PBW and Plateau pressure < 30 cmH2O for the at least the first 12 hours after inclusion in the protocol pH should be maintained between 7.35-7.45 Oxygenation (SpO2) target ranges 90-95% Maximum respiratory rate = 35 breaths/min PEEP and FIO2 adjusted according to the low PEEP-FiO2 Table. |
| EIT-Group | Experimental | Other: EIT-GroupThe goal is to maintain driving pressure (DP) < 16 cmH2O. Ventilatory mode: pressure-controlled ventilation After a recruitment a maneuver, PEEP will be chosen according to a PEEP titration maneuver monitored with electrical impedance tomography Plateau pressure may exceed 30 cmH2O and VT may exceed 6 mL/Kg if DP < 16 cmH2O pH should be maintained between 7.15-7.40 Oxygenation (SpO2) target ranges 90 -95% Maximum respiratory rate = 50 bpm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients under mechanical ventilation with ARDS (Berlin definition) caused by SARS-COV2 infection:
- ARDS diagnosis in less than 24 hours
- Respiratory System Compliance of 0.6 mL/cmH2O/Kg of PBW
Key exclusion criteria (13 listed)
- Age < 18 years
- Active bronchopleural fistula
- History of chronic and disabling respirator disease, requiring home oxygen treatment
- Chronic pulmonary arterial hypertension (pulmonary artery systolic pressure > 40 mmHg)
- Huge intrathoracic tumoral mass
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 |
|---|---|---|
| EIT-GroupA mechanical ventilation strategy with the main goal to maintain DP < 16 cmH2O | Other | EIT-Group |
| ARDSNetLow PEEP-FiO2 table ARDS Network ventilation protocol | Other | ARDSNet |
Primary outcome
Average daily Modified Lung injury score until day 28
Time frame: daily
This score originally ranges from 0 to 4 points based on the average of 4 parameters (PaO2/FiO2, chest X-Ray, PEEP level, and Respiratory compliance). In the modified version, if the patient dies, he or she automatically receives a score of 5 irrespective of the other four parameters. If the patient is extubated, the score is automatically zero. We also substituted FiO2 for PEEP guaranteeing equivalence of the score when either the low or high PEEP-FiO2 table is applied.
5 secondary outcomes
High oxygen dependence free days until day 28
Time frame: 28 days
Mechanical ventilation free days until day 28
Time frame: 28 days
Incidence of shock or barotrauma
Time frame: 28 days
Incidence of acute renal failure requiring renal replacement therapy
Time frame: 28 days
28-day mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Derived from this study: PubMed 39311582Alcala GC, Ekkapat G, Medeiros KJ, Morais CCA, Xin Y, Giammatteo V, Bruno G, Nova A, Wanderley H, Buhl T, Victor M, Gaulton TG, La Vita CJ, Amato MBP, Ceradda M, Berra L, Ribeiro De Santis Santiago R. Monitoring Lung Function with Electrical Impedance Tomography in the Intensive Care Unit. J Vis Exp. 2024 Sep 6;(211). doi: 10.3791/66756.
- Derived from this study: PubMed 38849605Costa ELV, Alcala GC, Tucci MR, Goligher E, Morais CC, Dianti J, Nakamura MAP, Oliveira LB, Pereira SM, Toufen C Jr, Barbas CSV, Carvalho CRR, Amato MBP. Impact of extended lung protection during mechanical ventilation on lung recovery in patients with COVID-19 ARDS: a phase II randomized controlled trial. Ann Intensive Care. 2024 Jun 8;14(1):85. doi: 10.1186/s13613-024-01297-z.
- Derived from this study: PubMed 35767435Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077.
- 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.
Eduardo LV Costa, PhD principal investigator
Hospital das Clinicas from University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT-Group and ARDSNet in people with Respiratory Distress Syndrome and Mechanical Ventilation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 13 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 11 May 2022. 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 Brazil. 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 Eduardo LV Costa, PhD (+551130617361, eduardoleitecosta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily Modified Lung injury score until day 28 (time frame: daily). 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 NCT04497454, 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 11 May 2022.