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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04725084
Recruitment Status : Completed
First Posted : January 26, 2021
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Other: Use of High Flow Nasal Cannula alone Other: Use of Non-invasive Ventilation Other: Use of Continuous Positive Airway Pressure

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.

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Study Type : Observational
Actual Enrollment : 355 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Non-invasive Oxygenation Strategies in ICU Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : December 15, 2020
Actual Study Completion Date : December 15, 2020


Group/Cohort 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725084


Locations
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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, 77000
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
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Study Director: Jonathan Chelly, MD Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Publications:

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Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT04725084    
Other Study ID Numbers: 2021-CHITS-001
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
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
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury