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

NCT04725084 | Completed

• 1 other identifier: 2021-CHITS-001
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 4

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mechanical Ventilation free days

  Through Intensive Care Unit stay, up to 1 month

• Survival at ICU discharge

  At the moment of Intensive care unit discharge, up to 1 month

• ICU length of stay

  At the moment of Intensive care unit discharge, up to 1 month

• Complications during ICU stay

  Through Intensive Care Unit stay, up to 1 month

• Delay between admission and intubation

  Through Intensive Care Unit stay, up to 1 month

Study Arms (3)

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

Non-Invasive Ventilation treatment

Patients treated by non-invasive ventilation (combined or not with HFNC)

Other: Use of Non-invasive Ventilation

Continuous Positive Airway Pressure treatment

Patients treated by continuous positive airway pressure (combined or not with HFNC)

Other: Use of Continuous Positive Airway Pressure

Interventions

Use of High Flow Nasal Cannula alone OTHER

Use of high flow nasal cannula oxygen therapy alone

High Flow Nasal Cannula oxygen therapy treatment

Use of Non-invasive Ventilation OTHER

Use of non-invasive ventilation combined or not with high flow nasal cannula oxygen therapy

Non-Invasive Ventilation treatment

Use of Continuous Positive Airway Pressure OTHER

Use of continuous positive airway pressure combined or not with high flow nasal cannula oxygen therapy

Continuous Positive Airway Pressure treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• patient opposition to participate in the study
• patients under judicial protection measures

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (4)

Centre Hospitalier de Bethune

Béthune, Hauts-de-France, France

Location

Grand Hôpital de l'Est Francilien

Jossigny, Seine-et-Marne, France

Location

Groupe Hospitalier Sud Ile de France

Melun, Seine-et-Marne, 77000, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83056, France

Location

Related Publications (6)

• 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.

  PMID: 33211135 BACKGROUND

• 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.

  PMID: 32222812 BACKGROUND

• 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.

  PMID: 30888444 BACKGROUND

• 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.

  PMID: 32624495 BACKGROUND

• 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.

  PMID: 33067061 BACKGROUND

• 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.

  PMID: 36448989 RESULT

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jonathan Chelly, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: July 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: February 9, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)