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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04725084
Acronym
SONIC-19
Enrollment
355
Registered
2021-01-26
Start date
2020-07-01
Completion date
2020-12-15
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERUse of High Flow Nasal Cannula alone

Use of high flow nasal cannula oxygen therapy alone

OTHERUse of Non-invasive Ventilation

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

OTHERUse of Continuous Positive Airway Pressure

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

Sponsors

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Refractory hypoxemiaThrough Intensive Care Unit stay, an average of 15 daysRate of refractory hypoxemia outcome defined by invasive Mechanical Ventilation (endotracheal intubation) requirement or death of non-intubated patients because of therapeutical limitation

Secondary

MeasureTime frameDescription
Mechanical Ventilation free daysThrough Intensive Care Unit stay, up to 1 monthNumbers of days without invasive mechanical ventilation during ICU stay and until ICU discharge
Survival at ICU dischargeAt the moment of Intensive care unit discharge, up to 1 monthRate of patients alive at the moment of intensive care unit discharge
ICU length of stayAt the moment of Intensive care unit discharge, up to 1 monthNumber of days spent in Intensive care unit
Complications during ICU stayThrough Intensive Care Unit stay, up to 1 monthNumber of complications during intensive care unit stay: pneumothorax, pneumomediastinum
Delay between admission and intubationThrough Intensive Care Unit stay, up to 1 monthPeriod of time (in hours or days) between admission in Intensive Care Unit and intubation requirement with invasive mechanical ventilation.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026