An observational study in ARDS, Human, Ventilation Therapy; Complications and Alveolar; Disorder, sponsored by Bicetre Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by Bicetre Hospital · Observational
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.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 34 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Bicetre Hospital is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
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Mechanically ventilated patients over the age of 18, exhibiting ARDS and with a PAC-monitoring already in place.
Exclusion Criteria:
PAC already in place
Esophagal pressure already in place
Correlation between PVR and recruitment-to-inflation ratio
PVR collected at two levels of PEEP and the R/I ratio to assess a relationship between the two variables
Time frame: Up to hospital discharge (maximum : day 60)
Relationship between the R/I ratio and blood gas analysis
Data collected from the daily blood samples, to assess a relationship between R/I and arterial oxygen pressure
Time frame: Up to hospital discharge (maximum : day 60)
Relationship between the R/I ratio and respiratory system compliance
Ventilatory parameters collected at two levels of PEEP and R/I collected every day to assess a correlation between R/I and lung compliance
Time frame: Up to hospital discharge (maximum : day 60)
Relationship between right ventricle size and R/I ratio
Echocardiographic data collected at two levels of PEEP and R/I collected every day to assess a relationship between R/I and changes in RV surface.
Time frame: Up to hospital discharge (maximum : day 60)
Relationship between PVR change and Transpulmonary gradient (TPG) according to R/I
Data collected from PAC and R/I measure every day to assess the relationship between R/I and TPG at two levels of PEEP.
Time frame: Up to hospital discharge (maximum : day 60)
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Bicetre Hospital