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

Completed

• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Procedure: Prone positioning session

• Registration Number: NCT05360862
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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 Timeline

• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-04
• Study Start: 2022-11-03
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prone positioning session	Prone positioning session	-

Primary Outcome Measures

Name	Time	Method
Prone positioning-induced decrease in R/I ratio.	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 Outcome Measures

Name	Time	Method
Proportion of patients "responders" to prone positioning session	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.
Clinical and respiratory predictors of prone positioning response in terms of oxygenation	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

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 Nice, France