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

Completed

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

• Registration Number: NCT04725084
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-26
• Status Verified: 2022-10
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Invasive Ventilation treatment	Use of Non-invasive Ventilation	Patients treated by non-invasive ventilation (combined or not with HFNC)
High Flow Nasal Cannula oxygen therapy treatment	Use of High Flow Nasal Cannula alone	Patients treated only by high flow nasal cannula oxygen therapy
Continuous Positive Airway Pressure treatment	Use of Continuous Positive Airway Pressure	Patients treated by continuous positive airway pressure (combined or not with HFNC)

Primary Outcome Measures

Name	Time	Method
Refractory hypoxemia	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

Name	Time	Method
Survival at ICU discharge	At the moment of Intensive care unit discharge, up to 1 month	Rate of patients alive at the moment of intensive care unit discharge
ICU length of stay	At the moment of Intensive care unit discharge, up to 1 month	Number of days spent in Intensive care unit
Complications during ICU stay	Through Intensive Care Unit stay, up to 1 month	Number of complications during intensive care unit stay: pneumothorax, pneumomediastinum
Mechanical Ventilation free days	Through Intensive Care Unit stay, up to 1 month	Numbers of days without invasive mechanical ventilation during ICU stay and until ICU discharge
Delay between admission and intubation	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.

Trial Locations

Locations (4)

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

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer; 🇫🇷 Toulon, Var, France