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

NCT04932590 | Completed

• 2 other identifiers: APHP201320ID RCB 2020-A02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shock

Keywords

Shock; Invasive mechanical ventilation; Fluid responsiveness; Heart-lung interactions; End-expiratory occlusion test; Newborns and infants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Heart rate

  25 minutes

• Systolic and diastolic blood pressures and mean arterial pressure

  25 minutes

• Arterial pulse pressure

  25 minutes

• Stroke volume

  25 minutes

• Aortic velocity time integral

  25 minutes

Study Arms (1)

Patients

EXPERIMENTAL

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

Interventions

End-expiratory occlusion test OTHER

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.

Patients

Eligibility Criteria

• Age: 0 Years - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Armand Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yaël LEVY, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Pierre-Louis LEGER, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 21, 2021
• Study Start: December 24, 2021
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)