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Completed

NCT Number: NCT04725084

Comparison of Non-invasive Oxygenation Strategies in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Bethune, Béthune, Hauts-de-France, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of High Flow Nasal Cannula alone

Other

Use of high flow nasal cannula oxygen therapy alone

Use of Non-invasive Ventilation

Other

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

Use of Continuous Positive Airway Pressure

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

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

Acronym: SONIC-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2021
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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