Clinical trial NCT05524558: Assessment of the Hemodynamic Effects of PEEP According to Alveolar Recruitment During the ARDS
Official title: Assessment of the Hemodynamic Effects of PEEP According to Alveolar Recruitment During the ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS, Human
Ventilation Therapy; Complications
Alveolar; Disorder
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients over the age of 18, exhibiting ARDS and with a PAC-monitoring already in place.

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.

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

Primary outcomes:
measure: Correlation between PVR and recruitment-to-inflation ratio
timeFrame: Up to hospital discharge (maximum : day 60)
Secondary outcomes:
measure: Relationship between the R/I ratio and blood gas analysis
timeFrame: Up to hospital discharge (maximum : day 60)
measure: Relationship between the R/I ratio and respiratory system compliance
timeFrame: Up to hospital discharge (maximum : day 60)
measure: Relationship between right ventricle size and R/I ratio
timeFrame: Up to hospital discharge (maximum : day 60)
measure: Relationship between PVR change and Transpulmonary gradient (TPG) according to R/I
timeFrame: Up to hospital discharge (maximum : day 60)
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Bicetre Hospital
state: Ile-de-France
Study officials:
References:
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