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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: 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
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prone positioning session	Procedure: Prone positioning session; To perform respiratory measurements before, during and after a prone positioning session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients "responders" to prone positioning session	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
Clinical and respiratory predictors of prone positioning response in terms of oxygenation	TROC curves of clinical and biological variables for prediction of response to prone positioning	16-hour prone positioning session and 4-hour period after supine repositioning

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; ARDS; Prone positioning; Lung recruitement
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 22-PP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing data plan is sheduled.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No