Prone Positioning and R/I Ratio in COVID-19 Patients With ARDS (SyDRAC-DV)

Centre Hospitalier Universitaire de Nice92 enrolled

Overview

The purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in COVID-19 patients with acute respiratory distress syndrome.

High positive end-expiratory pressure (PEEP) level and prone positioning (PP) are recommended in patients with moderate to severe acute respiratory distress syndrome (ARDS) in order to recruit lung and thus to improve oxygenation. Thus, high PEEP level and prone positioning will be more effective in patients with high potential for lung recruitment. Recently, the Recruitment-to-Inflation Ratio (R/I ratio) has been described and validated in patients with ARDS to estimate the potential for lung recruitment. In this regard, the R/I ration may be of interest to titrate PEEP level in patients with ARDS. This would be of particular interest in COVID-19 patients with ARDS, since different ARDS phenotypes with heterogeneous potential of lung recruitment have been described in these patients. However, the effects of prone positioning on R/I ratio have been scarcely described so far. Thus, the main goal of this study is to investigate the effects of prone positioning on the R/I ratio in COVID-19 patients with ARDS. The second goal of this study is to determine the effects of prone positioning on oxygenation and respiratory mechanics according to the R/I ratio.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Interventions

Prone positioning sessionPROCEDURE

To perform respiratory measurements before, during and after a prone positioning session.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Invasive mechanical ventilation 2. Patients with acute respiratory distress syndrome according to the Berlin definition 3. Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs or pulmonary samples. 4. Indication to a prone positioning session by the attending physician Exclusion Criteria: 1. Age \<18 years and pregnant women 2. Patients under legal protection 3. Acute core pulmonale 4. Pneumothorax and/or chest drainage 5. Hemodynamic failure 1. Increase in norepinephrine dosage \>30% within the last 6 hours 2. Norepinephrine dosage \> 0.5 mg/kg/min

Locations (1)

CHU de NICE

Nice, France

Outcomes

Primary Outcomes

Prone positioning-induced decrease in R/I ratio.

The R/I ratio will be calculated before (within 30 minutes before), during (2h, 8h and 16h) and after (2h and 4h after) a prone positioning session.

Time frame: 16-hour prone positioning session and 4-hour period after supine repositioning

Secondary Outcomes

Proportion of patients "responders" to prone positioning session

The R/I ratio will be calculated before (within 30 minutes before), during (2h, 8h and 16h) and after (2h and 4h after) a prone positioning session.

Time frame: 16-hour prone positioning session and 4-hour period after supine repositioning

Clinical and respiratory predictors of prone positioning response in terms of oxygenation

TROC curves of clinical and biological variables for prediction of response to prone positioning

Time frame: 16-hour prone positioning session and 4-hour period after supine repositioning

Data from ClinicalTrials.gov

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