Comparison of Non-invasive Oxygenation Strategies in Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Clinical Trial

— SONIC-19  

Official title:

Comparison of Non-invasive Oxygenation Strategies in ICU Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04725084
• Other study ID #: 2021-CHITS-001
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Coronavirus Infections
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Syndrome

Intervention

Other:
• Use of High Flow Nasal Cannula alone
Use of high flow nasal cannula oxygen therapy alone
• Use of Non-invasive Ventilation
Use of non-invasive ventilation combined or not with high flow nasal cannula oxygen therapy
• Use of Continuous Positive Airway Pressure
Use of continuous positive airway pressure combined or not with high flow nasal cannula oxygen therapy

Locations

Country	Name	City	State
France	Centre Hospitalier de Bethune	Béthune	Nord-Pas-de-Calais
France	Grand Hôpital de l'Est Francilien	Jossigny	Seine-et-Marne
France	Groupe Hospitalier Sud Ile de France	Melun	Seine-et-Marne
France	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

References & Publications (6)

Alhazzani 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. — View Citation

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. — View Citation

Chelly 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 admi — View Citation

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. — View Citation

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):e000639. doi: 10.1136/bmjresp-2020-000639. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through Intensive Care Unit stay, an average of 15 days
Secondary	Mechanical Ventilation free days	Numbers of days without invasive mechanical ventilation during ICU stay and until ICU discharge	Through Intensive Care Unit stay, up to 1 month
Secondary	Survival at ICU discharge	Rate of patients alive at the moment of intensive care unit discharge	At the moment of Intensive care unit discharge, up to 1 month
Secondary	ICU length of stay	Number of days spent in Intensive care unit	At the moment of Intensive care unit discharge, up to 1 month
Secondary	Complications during ICU stay	Number of complications during intensive care unit stay: pneumothorax, pneumomediastinum	Through Intensive Care Unit stay, up to 1 month
Secondary	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.	Through Intensive Care Unit stay, up to 1 month