Clinical trial NCT04725084: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Refractory hypoxemia
timeFrame: Through Intensive Care Unit stay, an average of 15 days
Secondary outcomes:
measure: Mechanical Ventilation free days
timeFrame: Through Intensive Care Unit stay, up to 1 month
measure: Survival at ICU discharge
timeFrame: At the moment of Intensive care unit discharge, up to 1 month
measure: ICU length of stay
timeFrame: At the moment of Intensive care unit discharge, up to 1 month
measure: Complications during ICU stay
timeFrame: Through Intensive Care Unit stay, up to 1 month
measure: Delay between admission and intubation
timeFrame: Through Intensive Care Unit stay, up to 1 month
Other outcomes:
Locations:
city: Béthune
country: France
facility: Centre Hospitalier de Bethune
state: Nord-Pas-de-Calais
city: Jossigny
country: France
facility: Grand Hôpital de l'Est Francilien
state: Seine-et-Marne
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile de France
state: Seine-et-Marne
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Jonathan Chelly, MD
role: STUDY_DIRECTOR
References:
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