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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05360862
Acronym
SyDRAC-DV
Enrollment
92
Registered
2022-05-04
Start date
2022-11-03
Completion date
2023-09-29
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

ARDS, COVID-19, Prone positioning, Lung recruitement

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.

Interventions

PROCEDUREProne positioning session

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prone positioning-induced decrease in R/I ratio.16-hour prone positioning session and 4-hour period after supine repositioningThe 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

MeasureTime frameDescription
Proportion of patients responders to prone positioning session16-hour prone positioning session and 4-hour period after supine repositioningThe 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.
Clinical and respiratory predictors of prone positioning response in terms of oxygenation16-hour prone positioning session and 4-hour period after supine repositioningTROC curves of clinical and biological variables for prediction of response to prone positioning

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026