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Clinical Trials/NCT05524558
NCT05524558
Unknown
Not Applicable

Assessment of the Hemodynamic Effects of PEEP According to Alveolar Recruitment During the ARDS

Bicetre Hospital1 site in 1 country34 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS, Human
Sponsor
Bicetre Hospital
Enrollment
34
Locations
1
Primary Endpoint
Correlation between PVR and recruitment-to-inflation ratio
Last Updated
3 years ago

Overview

Brief Summary

The corner stone of the treatment of ARDS is mechanical ventilation with high levels of positive end-expiratory pressure, also called PEEP. A high level of PEEP is recommended and frequently used. But PEEP can lower cardiac output and contribute to circulatory failure during mechanical ventilation. Nevertheless, in theory, the PEEP-induced pulmonary vascular resistance (PVR) increase could depend on the level of alveolar recruitment, but it has never been proven. Thus, the aim of this study is to determine the relation between the high-PEEP induced PVR and the alveolar recruitment or overdistension.

Detailed Description

During acute respiratory distress syndrome (ARDS) the application of positive end-expiratory pressure (PEEP) prevents expiratory alveolar collapse. However, it can induce a predominant recruitment effect or, on the contrary, alveolar overdistension. The recruitment/overdistension ratio can be easily assessed using R/I ratio (or recruitment-to-inflation ratio). However, PEEP is likely to lower cardiac output and contribute to the cardiovascular failure that often occurs in patients with ARDS. Among its hemodynamic effects, PEEP is likely to increase pulmonary vascular resistance and, thus, right ventricular afterload. In theory, this effect should only occur if PEEP over-distends the lung volume, compressing the "extra-alveolar" vessels and increasing their resistance. However, this different effect of PEEP on pulmonary vascular resistance depending on the degree of recruitment or overdistension has never been demonstrated during ARDS in humans. We retrospectively studied data collected from patients with ARDS, monitored by pulmonary artery catheter (PAC), to eventually find a correlation between the high PEEP-induced PVR increase and recruitement/overdistension profile.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
November 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bicetre Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xavier Monnet

Professor

Bicetre Hospital

Eligibility Criteria

Inclusion Criteria

  • ARDS diagnosed
  • Invasive mechanical ventilation
  • Pulmonary artery catheter already in place
  • Esophagal pressure measure

Exclusion Criteria

  • Pregnancy
  • Prone position at inclusion
  • Legal protection measures

Outcomes

Primary Outcomes

Correlation between PVR and recruitment-to-inflation ratio

Time Frame: Up to hospital discharge (maximum : day 60)

PVR collected at two levels of PEEP and the R/I ratio to assess a relationship between the two variables

Secondary Outcomes

  • Relationship between the R/I ratio and blood gas analysis(Up to hospital discharge (maximum : day 60))
  • Relationship between the R/I ratio and respiratory system compliance(Up to hospital discharge (maximum : day 60))
  • Relationship between right ventricle size and R/I ratio(Up to hospital discharge (maximum : day 60))
  • Relationship between PVR change and Transpulmonary gradient (TPG) according to R/I(Up to hospital discharge (maximum : day 60))

Study Sites (1)

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