Clinical trial NCT05360862: Prone Positioning and R/I Ratio in COVID-19 Patients With ARDS (SyDRAC-DV)
Official title: Effects of Prone Positioning-induced on the Recruitment-to-inflation Ratio in COVID-19 Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: ARDS
COVID-19
Prone positioning
Lung recruitement
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients are COVID-19 patients with moderate to severe ARDS under mechanical ventilation in whom prone positioning is indicated.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prone positioning-induced decrease in R/I ratio.
timeFrame: 16-hour prone positioning session and 4-hour period after supine repositioning
Secondary outcomes:
measure: Proportion of patients "responders" to prone positioning session
timeFrame: 16-hour prone positioning session and 4-hour period after supine repositioning
measure: Clinical and respiratory predictors of prone positioning response in terms of oxygenation
timeFrame: 16-hour prone positioning session and 4-hour period after supine repositioning
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
Study officials:
References: