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

NCT ID: NCT05360862

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-03

Study Completion Date

2023-09-29

Brief Summary

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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

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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.

Conditions

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COVID-19 Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Prone positioning session

Prone positioning session

Intervention Type PROCEDURE

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

Interventions

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Prone positioning session

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de NICE

Nice, , France

Site Status

Countries

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France

Other Identifiers

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22-PP-02

Identifier Type: -

Identifier Source: org_study_id

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