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

NCT05360862 | Completed

• 1 other identifier: 22-PP-02
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

ARDS; COVID-19; Prone positioning; Lung recruitement

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (2)

• 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

Study Arms (1)

Prone positioning session

Procedure: Prone positioning session

Interventions

Prone positioning session PROCEDURE

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

Prone positioning session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06200, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 4, 2022
• Study Start: November 3, 2022
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)