SONIC-19: Comparison of Non-invasive Oxygenation Strategies in Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| High Flow Nasal Cannula oxygen therapy treatment Patients treated only by high flow nasal cannula oxygen therapy |
Other: Use of High Flow Nasal Cannula alone
Use of high flow nasal cannula oxygen therapy alone
|
| Non-Invasive Ventilation treatment Patients treated by non-invasive ventilation (combined or not with HFNC) |
Other: Use of Non-invasive Ventilation
Use of non-invasive ventilation combined or not with high flow nasal cannula oxygen therapy
|
| Continuous Positive Airway Pressure treatment Patients treated by continuous positive airway pressure (combined or not with HFNC) |
Other: Use of Continuous Positive Airway Pressure
Use of continuous positive airway pressure combined or not with high flow nasal cannula oxygen therapy
|
Outcome Measures
Primary Outcome Measures
- Refractory hypoxemia [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
Secondary Outcome Measures
- Mechanical Ventilation free days [Through Intensive Care Unit stay, up to 1 month]
Numbers of days without invasive mechanical ventilation during ICU stay and until ICU discharge
- Survival at ICU discharge [At the moment of Intensive care unit discharge, up to 1 month]
Rate of patients alive at the moment of intensive care unit discharge
- ICU length of stay [At the moment of Intensive care unit discharge, up to 1 month]
Number of days spent in Intensive care unit
- Complications during ICU stay [Through Intensive Care Unit stay, up to 1 month]
Number of complications during intensive care unit stay: pneumothorax, pneumomediastinum
- Delay between admission and intubation [Through Intensive Care Unit stay, up to 1 month]
Period of time (in hours or days) between admission in Intensive Care Unit and intubation requirement with invasive mechanical ventilation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
patient opposition to participate in the study
-
patients under judicial protection measures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier de Bethune | Béthune | Nord-Pas-de-Calais | France | |
| 2 | Grand Hôpital de l'Est Francilien | Jossigny | Seine-et-Marne | France | |
| 3 | Groupe Hospitalier Sud Ile de France | Melun | Seine-et-Marne | France | 77000 |
| 4 | Centre Hospitalier Intercommunal Toulon La Seyne sur Mer | Toulon | Var | France | 83056 |
Sponsors and Collaborators
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Investigators
- Study Director: Jonathan Chelly, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Study Documents (Full-Text)
None provided.More Information
Publications
- Alhazzani W, Møller 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.
- Avdeev 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.
- 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.
- Nightingale 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). pii: e000639. doi: 10.1136/bmjresp-2020-000639.
- Rochwerg 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.
- 2021-CHITS-001