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Completed

NCT Number: NCT05360862

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Prone positioning session

Procedure

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

Primary outcomes

  1. Prone positioning-induced decrease in R/I ratio.

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

    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.

Secondary outcomes

  1. Proportion of patients "responders" to prone positioning session

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

    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.

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

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

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Effects of Prone Positioning-induced on the Recruitment-to-inflation Ratio in COVID-19 Patients With Acute Respiratory Distress Syndrome

Acronym: SyDRAC-DV

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 4, 2022
Registry last updated
Feb 8, 2024

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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