Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)SONIC-19NCT04725084
Comparison of Non-invasive Oxygenation Strategies in Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 4 sites in France.
Trial summary
Acute Respiratory Distress Syndrome (ARDS) is the main clinical presentation of SARS-CoV-2 (Covid-19) infected patients admitted in Intensive Care Unit (ICU). During the first phase of the outbreak (between February and May 2020), the use of invasive Mechanical Ventilation (MV) was largely required with 63% of ICU… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- What is being tested?
- Use of High Flow Nasal Cannula alone, Use of Non-invasive Ventilation and Use of Continuous Positive Airway Pressure
- How many people
- 355 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jul 2020to 15 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients admitted in intensive care unit for an acute respiratory distress syndrome related to a documented SARS-CoV-2 disease
Who may be able to join
- patients admitted in intensive care unit because of a SARS-CoV-2 infection confirmed by PCR wherever was collected the analyzed sample
- acute respiratory distress syndrome according to Berlin criteria
- age superior or equal to 18 years old
Who cannot join
- patient opposition to participate in the study
- patients under judicial protection measures
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier de Bethune
Béthune, Hauts-de-France
Grand Hôpital de l'Est Francilien
Jossigny, Seine-et-Marne
Groupe Hospitalier Sud Ile de France
Melun, Seine-et-Marne, 77000
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056
About this study
Official title: Comparison of Non-invasive Oxygenation Strategies in ICU Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome (ARDS) is the main clinical presentation of SARS-CoV-2 (Covid-19) infected patients admitted in Intensive Care Unit (ICU).
During the first phase of the outbreak (between February and May 2020), the use of invasive Mechanical Ventilation (MV) was largely required with 63% of ICU patients intubated in the first 24 hours after admission and up to 80% of patients during the overall ICU stay. Mortality was especially higher when using MV in the first 24 hours. In contrast, the use of non-invasive oxygenation strategies in the first 24 hours was only 19% for High Flow Nasal Cannula oxygen therapy (HFNC) and 6% for Non-Invasive Ventilation (NIV).
Read more
Several non-invasive oxygenation strategies were proposed in order to delay or avoid MV in ICU patients suffering from Covid-19 ARDS. The use of HFNC became the recommended oxygenation strategy, based in particular on publications prior to the outbreak. The use of NIV or Continuous Positive Airway Pressure (CPAP) combined with HFNC have also been proposed. Although these non-invasive oxygenation strategies seem widely used in the second phase of the outbreak, they have not yet confirmed their clinical impact on MV requirement and patient's outcome. Moreover, no comparison has been made between these different non-invasive oxygenation strategies.
The aim of this study is to compare different non-invasive oxygenation strategies (HFNC, NIV, CPAP) on MV requirement and outcome in ICU patients treated for ARDS related to Covid-19.
Read the detailed description
Retrospective multicenter observational registry in French intensive care unit including all consecutive patients admitted for acute respiratory distress syndrome related to SARS-CoV-2 pneumonia between1st July and 31th December 2020.
Patients characteristics, ICU treatments and outcome will be recorded.
- Being tested
- Use of High Flow Nasal Cannula alone, Use of Non-invasive Ventilation, Use of Continuous Positive Airway Pressure
- Keywords
- Novel coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Acute respiratory distress syndrome, High flow nasal canula oxygen, Non-invasive ventilation, Continuous positive airway pressure
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of High Flow Nasal Cannula aloneOther
Use of high flow nasal cannula oxygen therapy alone
Use of Non-invasive VentilationOther
Use of non-invasive ventilation combined or not with high flow nasal cannula oxygen therapy
Use of Continuous Positive Airway PressureOther
Use of continuous positive airway pressure combined or not with high flow nasal cannula oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula oxygen therapy treatment | Patients treated only by high flow nasal cannula oxygen therapy Receives: Other: Use of High Flow Nasal Cannula alone | |
| Non-Invasive Ventilation treatment | Patients treated by non-invasive ventilation (combined or not with HFNC) Receives: Other: Use of Non-invasive Ventilation | |
| Continuous Positive Airway Pressure treatment | Patients treated by continuous positive airway pressure (combined or not with HFNC) Receives: Other: Use of Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractory hypoxemia
Rate of refractory hypoxemia outcome defined by invasive Mechanical Ventilation (endotracheal intubation) requirement or death of non-intubated patients because of therapeutical limitation
Measured: Through Intensive Care Unit stay, an average of 15 days
Secondary outcomes (5)
Mechanical Ventilation free days
Numbers of days without invasive mechanical ventilation during ICU stay and until ICU discharge
Measured: Through Intensive Care Unit stay, up to 1 month
Survival at ICU discharge
Rate of patients alive at the moment of intensive care unit discharge
Measured: At the moment of Intensive care unit discharge, up to 1 month
ICU length of stay
Number of days spent in Intensive care unit
Measured: At the moment of Intensive care unit discharge, up to 1 month
Complications during ICU stay
Number of complications during intensive care unit stay: pneumothorax, pneumomediastinum
Measured: Through Intensive Care Unit stay, up to 1 month
Delay between admission and intubation
Period of time (in hours or days) between admission in Intensive Care Unit and intubation requirement with invasive mechanical ventilation.
Measured: Through Intensive Care Unit stay, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jul 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Studies 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
- Retrospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Chelly, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725084
- Sponsor's protocol ID
- 2021-CHITS-001
- Acronym
- SONIC-19
- Status last verified
- Oct 2022
- First submitted
- 21 Jan 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.
PubMed 33211135Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
PubMed 32222812Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
PubMed 30888444Nightingale R, Nwosu N, Kutubudin F, Fletcher T, Lewis J, Frost F, Haigh K, Robinson R, Kumar A, Jones G, Brown D, Abouyannis M, Beadsworth M, Hampshire P, Aston S, Gautam M, Burhan H. Is continuous positive airway pressure (CPAP) a new standard of care for type 1 respiratory failure in COVID-19 patients? A retrospective observational study of a dedicated COVID-19 CPAP service. BMJ Open Respir Res. 2020 Jul;7(1):e000639. doi: 10.1136/bmjresp-2020-000639.
PubMed 32624495Avdeev SN, Yaroshetskiy AI, Tsareva NA, Merzhoeva ZM, Trushenko NV, Nekludova GV, Chikina SY. Noninvasive ventilation for acute hypoxemic respiratory failure in patients with COVID-19. Am J Emerg Med. 2021 Jan;39:154-157. doi: 10.1016/j.ajem.2020.09.075. Epub 2020 Oct 1.
PubMed 33067061Chelly J, Coupry LM, van Phach Vong L, Kamel T, Marzouk M, Terzi N, Bruel C, Autret A, Garnero A, Arnal JM. Comparison of high-flow nasal therapy, noninvasive ventilation, and continuous positive airway pressure on outcomes in critically ill patients admitted for COVID-19 with acute respiratory failure. Minerva Anestesiol. 2023 Jan-Feb;89(1-2):66-73. doi: 10.23736/S0375-9393.22.16918-X. Epub 2022 Nov 30.
PubMed 36448989
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-invasive Oxygenation Strategies in ICU Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04725084
- Acronym / sponsor ID
- SONIC-19 / 2021-CHITS-001
- Keywords
- Novel coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Acute respiratory distress syndrome, High flow nasal canula oxygen, Non-invasive ventilation, Continuous positive airway pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 26 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.
Acute Respiratory Distress Syndrome (ARDS) is the main clinical presentation of SARS-CoV-2 (Covid-19) infected patients admitted in Intensive Care Unit (ICU).
During the first phase of the outbreak (between February and May 2020), the use of invasive Mechanical Ventilation (MV) was largely required with 63% of ICU patients intubated in the first 24 hours after admission and up to 80% of patients during the overall ICU stay. Mortality was especially higher when using MV in the first 24 hours. In contrast, the use of non-invasive oxygenation strategies in the first 24 hours was only 19% for High Flow Nasal Cannula oxygen therapy (HFNC) and 6% for Non-Invasive Ventilation (NIV).
Several non-invasive oxygenation strategies were proposed in order to delay or avoid MV in ICU patients suffering from Covid-19 ARDS. The use of HFNC became the recommended oxygenation strategy, based in particular on publications prior to the outbreak. The use of NIV or Continuous Positive Airway Pressure (CPAP) combined with HFNC have also been proposed. Although these non-invasive oxygenation strategies seem widely used in the second phase of the outbreak, they have not yet confirmed their clinical impact on MV requirement and patient's outcome. Moreover, no comparison has been made between these different non-invasive oxygenation strategies.
The aim of this study is to compare different non-invasive oxygenation strategies (HFNC, NIV, CPAP) on MV requirement and outcome in ICU patients treated for ARDS related to Covid-19.
Detailed description
Retrospective multicenter observational registry in French intensive care unit including all consecutive patients admitted for acute respiratory distress syndrome related to SARS-CoV-2 pneumonia between1st July and 31th December 2020.
Patients characteristics, ICU treatments and outcome will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula oxygen therapy treatment | – | Other: Use of High Flow Nasal Cannula alonePatients treated only by high flow nasal cannula oxygen therapy |
| Non-Invasive Ventilation treatment | – | Other: Use of Non-invasive VentilationPatients treated by non-invasive ventilation (combined or not with HFNC) |
| Continuous Positive Airway Pressure treatment | – | Other: Use of Continuous Positive Airway PressurePatients treated by continuous positive airway pressure (combined or not with HFNC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted in intensive care unit for an acute respiratory distress syndrome related to a documented SARS-CoV-2 disease
Key inclusion criteria (3 listed)
- patients admitted in intensive care unit because of a SARS-CoV-2 infection confirmed by PCR wherever was collected the analyzed sample
- acute respiratory distress syndrome according to Berlin criteria
- age superior or equal to 18 years old
Key exclusion criteria (2 listed)
- patient opposition to participate in the study
- patients under judicial protection measures
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 |
|---|---|---|
| Use of High Flow Nasal Cannula aloneUse of high flow nasal cannula oxygen therapy alone | Other | High Flow Nasal Cannula oxygen therapy treatment |
| Use of Non-invasive VentilationUse of non-invasive ventilation combined or not with high flow nasal cannula oxygen therapy | Other | Non-Invasive Ventilation treatment |
| Use of Continuous Positive Airway PressureUse of continuous positive airway pressure combined or not with high flow nasal cannula oxygen therapy | Other | Continuous Positive Airway Pressure treatment |
Primary outcome
Refractory hypoxemia
Time frame: Through Intensive Care Unit stay, an average of 15 days
Rate of refractory hypoxemia outcome defined by invasive Mechanical Ventilation (endotracheal intubation) requirement or death of non-intubated patients because of therapeutical limitation
5 secondary outcomes
Mechanical Ventilation free days
Time frame: Through Intensive Care Unit stay, up to 1 month
Survival at ICU discharge
Time frame: At the moment of Intensive care unit discharge, up to 1 month
ICU length of stay
Time frame: At the moment of Intensive care unit discharge, up to 1 month
Complications during ICU stay
Time frame: Through Intensive Care Unit stay, up to 1 month
Delay between admission and intubation
Time frame: Through Intensive Care Unit stay, up to 1 month
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 9 Feb 2023.
- Background: PubMed 33211135COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.
- Background: PubMed 32222812Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
- Background: PubMed 30888444Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
- Background: PubMed 32624495Nightingale R, Nwosu N, Kutubudin F, Fletcher T, Lewis J, Frost F, Haigh K, Robinson R, Kumar A, Jones G, Brown D, Abouyannis M, Beadsworth M, Hampshire P, Aston S, Gautam M, Burhan H. Is continuous positive airway pressure (CPAP) a new standard of care for type 1 respiratory failure in COVID-19 patients? A retrospective observational study of a dedicated COVID-19 CPAP service. BMJ Open Respir Res. 2020 Jul;7(1):e000639. doi: 10.1136/bmjresp-2020-000639.
- Background: PubMed 33067061Avdeev SN, Yaroshetskiy AI, Tsareva NA, Merzhoeva ZM, Trushenko NV, Nekludova GV, Chikina SY. Noninvasive ventilation for acute hypoxemic respiratory failure in patients with COVID-19. Am J Emerg Med. 2021 Jan;39:154-157. doi: 10.1016/j.ajem.2020.09.075. Epub 2020 Oct 1.
- Results publication: PubMed 36448989Chelly J, Coupry LM, van Phach Vong L, Kamel T, Marzouk M, Terzi N, Bruel C, Autret A, Garnero A, Arnal JM. Comparison of high-flow nasal therapy, noninvasive ventilation, and continuous positive airway pressure on outcomes in critically ill patients admitted for COVID-19 with acute respiratory failure. Minerva Anestesiol. 2023 Jan-Feb;89(1-2):66-73. doi: 10.23736/S0375-9393.22.16918-X. Epub 2022 Nov 30.
- 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.
Jonathan Chelly, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 4 sites in France.
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 2 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 9 Feb 2023. 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 France. 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?
Refractory hypoxemia (time frame: Through Intensive Care Unit stay, an average of 15 days). 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 NCT04725084, 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 9 Feb 2023.