Hôpital Armand Trousseau
Paris, 75012, France
NCT Number: NCT04932590
To date, the end-expiratory occlusion test in infants or children has never been evaluated as a marker of preload dependence. It therefore appears clinically relevant to evaluate this new indicator to predict fluid responsiveness in all infants hospitalized in pediatric and neonatal intensive care.
The main objective of this study is to determine whether the hemodynamic effects of a 15-second end-expiratory occlusion were able to predict fluid responsiveness in the mechanically ventilated infant or newborn in pediatric intensive care.
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Notify Me0 year–2 year
All sexes
Interventional
Not applicable
Paris, 75012, France
Volume expansion remains one of the first resuscitation treatments for states of shock. Nonetheless, the decision to perform volume expansion should be based on a "functional" hemodynamic assessment, i.e., filling should only be performed if changes in cardiac preload result in significant changes in stroke volume. This is then referred to as preload dependency. Unnecessary volume expansion induces fluid overload and is associated with increased morbidity and mortality for shock conditions in infant and children.
In addition, several studies in adults and children have demonstrated the lack of effectiveness of so-called "static" preload variables as witnesses of preload dependence. Only "dynamic" preload variables, based on the notion of cardiopulmonary interaction during mechanical ventilation, can predict this preload dependence, however with very variable sensitivities and specificities depending on the studies.
The end-expiratory occlusion test is a dynamic preload dependency test that can be performed in patients on invasive ventilation. The test consists in interrupting the ventilator at end-expiration for 15 seconds, delaying the next insufflation thus allowing an increase in venous return to the right heart and then to the left heart. If the heart is preload dependent, an increase in venous return is accompanied by an increase in stroke volume and cardiac output (Franck-Starling's law). Volume expansion is usually considered effective or positive if cardiac output increases by more than 15% from baseline.
To date, the end-expiratory occlusion test in infants or children has never been evaluated as a marker of preload dependence. It therefore appears clinically relevant to evaluate this new indicator to predict fluid responsiveness in all infants hospitalized in pediatric and neonatal intensive care.
The main objective of this study is to determine whether the hemodynamic effects of a 15-second end-expiratory occlusion were able to predict fluid responsiveness in the mechanically ventilated infant or newborn in pediatric intensive care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The test consists in interrupting the ventilator at end-expiration for 15 seconds and assessing the resulting changes in cardiac output. Delays necessary to allow sufficient pulmonary transit time to allow good pulmonary venous return and therefore an increase in cardiac preload.
Time frame: 25 minutes
Cardiac output measured by cardiac ultrasound before and during end-expiratory occlusion and after volume expansion.
A positive response to end-expiratory occlusion is defined as an increase in cardiac output ≥ 15%.
A positive response to the volume expansion test is defined as an increase in cardiac output ≥ 15%.
Time frame: 25 minutes
Heart rate measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Time frame: 25 minutes
Recorded using a bedside monitor before and during end-expiratory pause and after volume expansion.
Time frame: 25 minutes
Pressure waveform analysis was performed online with the soft tracing provided by the monitor.
∆PP (%) = PP max-PP min)/[(PP max+PP min)/2] × 100).
Time frame: 25 minutes
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Time frame: 25 minutes
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Time frame: 25 minutes
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Assistance Publique - Hôpitaux de Paris
Other
Predicting Fluid Responsiveness During Shock State by End-expiratory Occlusion Test in Newborns and Infants : EVEOC Study
Acronym: EVEOC
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