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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05360862
Collaborator
(none)
80
1
19
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Effects of Prone Positioning-induced on the Recruitment-to-inflation Ratio in COVID-19 Patients With Acute Respiratory Distress Syndrome
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Prone positioning session

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  6. Increase in norepinephrine dosage >30% within the last 6 hours

  7. Norepinephrine dosage > 0.5 mg/kg/min

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de NICE Nice France 06200

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05360862
Other Study ID Numbers:
  • 22-PP-02
First Posted:
May 4, 2022
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Nice
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2022