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

• ClinicalTrials.gov Identifier: NCT04725084
• Recruitment Status: Completed
• First Posted: January 26, 2021
• Last Update Posted: February 9, 2023
• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Information provided by (Responsible Party): Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Tracking Information

• First Submitted Date: January 21, 2021
• First Posted Date: January 26, 2021
• Last Update Posted Date: February 9, 2023
• Actual Study Start Date: July 1, 2020
• Actual Primary Completion Date: December 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 25, 2021)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 25, 2021)

• Mechanical Ventilation free days [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At the moment of Intensive care unit discharge, up to 1 month ]
  Number of days spent in Intensive care unit
• Complications during ICU stay [ Time Frame: Through Intensive Care Unit stay, up to 1 month ]
  Number of complications during intensive care unit stay: pneumothorax, pneumomediastinum
• Delay between admission and intubation [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Non-invasive Oxygenation Strategies in Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome
• Official Title: Comparison of Non-invasive Oxygenation Strategies in ICU Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome

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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All consecutive patients admitted in intensive care unit for an acute respiratory distress syndrome related to a documented SARS-CoV-2 disease
• Condition: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Intervention

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

Study Groups/Cohorts

• High Flow Nasal Cannula oxygen therapy treatment
  Patients treated only by high flow nasal cannula oxygen therapy
  Intervention: Other: Use of High Flow Nasal Cannula alone
• Non-Invasive Ventilation treatment
  Patients treated by non-invasive ventilation (combined or not with HFNC)
  Intervention: Other: Use of Non-invasive Ventilation
• Continuous Positive Airway Pressure treatment
  Patients treated by continuous positive airway pressure (combined or not with HFNC)
  Intervention: Other: Use of Continuous Positive Airway Pressure

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.
• 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.
• 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.
• 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.
• 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.
• 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 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2022): 355
• Original Actual Enrollment (submitted: January 25, 2021): 300
• Actual Study Completion Date: December 15, 2020
• Actual Primary Completion Date: December 15, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04725084
• Other Study ID Numbers: 2021-CHITS-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jonathan Chelly, MD; Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

• PRS Account: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Verification Date: October 2022