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

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

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.

Study Overview

• Status: Completed
• Conditions: Shock
• Intervention / Treatment: Other: End-expiratory occlusion test

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Hôpital Armand Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Newborn and infant <2 years.
• Born at or near term (> 36 weeks of amenorrhea).
• Hospitalized in pediatric and neonatal intensive care.
• Requiring the use of invasive mechanical ventilation.
• In a state of shock defined by a cardio-circulatory dysfunction associating arterial hypotension, an alteration in organ perfusion, one or more organ dysfunctions or vasopressor's requirement. Clinical signs retained: heart rate ≥ 90th percentile associated with at least one sign of peripheral hypoperfusion represented by a a capillary refill time ≥ 3sec, or the presence of mottling or coldness of the extremities or urine output ≤ 0.5ml / kg / h or disturbance of consciousness.
• The practitioner in charge of the patient has decided to perform volume expansion.
• Non-opposition expressed by the holders of parental authority.

Exclusion Criteria:

• Any serious and urgent clinical hemodynamic situation, the management of which would be delayed by inclusion in the protocol.
• Patient with unoperated congenital heart disease.
• Patient in spontaneous or non-invasive ventilation or with spontaneous ventilatory cycles in invasive ventilation.
• Patient in prolonged cardiac arrest (> 5min) or refractory.
• Patient under venous-arterial extracorporeal membrane oxygenation.
• Refusal of the holders of parental authority to exploit the collected data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; Patients less than 2 years old admitted in the pediatric intensive care unit of the Armand-Trousseau hospital, under invasive mechanical ventilation and in whom a volume expansion is planned by the attending physicians.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output	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%.	25 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.	25 minutes
Systolic and diastolic blood pressures and mean arterial pressure	Recorded using a bedside monitor before and during end-expiratory pause and after volume expansion.	25 minutes
Arterial pulse pressure	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).	25 minutes
Stroke volume	Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.	25 minutes
Aortic velocity time integral	Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.	25 minutes
Aortic blood flow velocity	Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.	25 minutes

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Yaël LEVY, MD, Assistance Publique - Hôpitaux de Paris; Study Director: Pierre-Louis LEGER, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2021
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Shock; Fluid responsiveness; Invasive mechanical ventilation; End-expiratory occlusion test; Heart-lung interactions; Newborns and infants
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock
• Other Study ID Numbers: APHP201320; ID RCB 2020-A02 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No