NCT04932590

Predicting Fluid Responsiveness During Shock in Newborns and Infants by End-expiratory Occlusion Test

Predicting Fluid Responsiveness During Shock State by End-expiratory Occlusion Test in Newborns and Infants : EVEOC Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 0 Years – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Shock

Interventions

Type	Name	Description
OTHER	End-expiratory occlusion test	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.

Timeline

• Start date: 2021-12-24
• Primary completion: 2023-09-15
• Completion: 2023-09-15
• First posted: 2021-06-21
• Last updated: 2026-03-31

Locations

1 site across 1 country: France