Skip to main content
Clinical Trials/NCT05360862
NCT05360862CompletedNot Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country92 target enrollmentStarted: November 3, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
92
Locations
1
Primary Endpoint
Prone positioning-induced decrease in R/I ratio.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Proportion of patients "responders" to prone positioning session(16-hour prone positioning session and 4-hour period after supine repositioning)
  • Clinical and respiratory predictors of prone positioning response in terms of oxygenation(16-hour prone positioning session and 4-hour period after supine repositioning)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials