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NCT05360862 | Completed | COVID-19 Acute Respiratory Distress Syndrome


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

Nice University Hospital Center

Brief Summary:

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

Condition or disease

COVID-19 Acute Respiratory Distress Syndrome

Intervention/treatment

Prone positioning session

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.}}

Study Type : Observational
Estimated Enrollment : 92 participants
Official Title : Effects of Prone Positioning-induced on the Recruitment-to-inflation Ratio in COVID-19 Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date : November 3, 2022
Estimated Primary Completion Date : September 29, 2023
Estimated Study Completion Date : September 29, 2023

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Invasive mechanical ventilation
  • Patients with acute respiratory distress syndrome according to the Berlin definition
  • Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs or pulmonary samples.
  • Indication to a prone positioning session by the attending physician
Exclusion Criteria
  • Age <18 years and pregnant women
  • Patients under legal protection
  • Acute core pulmonale
  • Pneumothorax and/or chest drainage
  • Hemodynamic failure
  • Increase in norepinephrine dosage >30% within the last 6 hours
  • Norepinephrine dosage > 0.5 mg/kg/min

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

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

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Locations


Not yet recruiting

France,

chu's nice

Nice, France, 06200

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