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

February 7, 2023 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord-Pas-de-Calais
      • Béthune, Nord-Pas-de-Calais, France
        • Centre Hospitalier de Béthune
    • Seine-et-Marne
      • Jossigny, Seine-et-Marne, France
        • Grand Hôpital de l'Est Francilien
      • Melun, Seine-et-Marne, France, 77000
        • Groupe Hospitalier Sud Ile de France
    • Var
      • Toulon, Var, France, 83056
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through Intensive Care Unit stay, an average of 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through Intensive Care Unit stay, up to 1 month
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
At the moment of Intensive care unit discharge, up to 1 month
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
At the moment of Intensive care unit discharge, up to 1 month
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
Through Intensive Care Unit stay, up to 1 month
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.
Through Intensive Care Unit stay, up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ACTUAL)

December 15, 2020

Study Completion (ACTUAL)

December 15, 2020

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (ACTUAL)

January 26, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-CHITS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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