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

Primary Purpose

Shock

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
End-expiratory occlusion test
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock focused on measuring Shock, Invasive mechanical ventilation, Fluid responsiveness, Heart-lung interactions, End-expiratory occlusion test, Newborns and infants

Eligibility Criteria

0 Years - 2 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Armand TrousseauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2021
Last Updated
January 24, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04932590
Brief Title
Predicting Fluid Responsiveness During Shock in Newborns and Infants by End-expiratory Occlusion Test
Acronym
EVEOC
Official Title
Predicting Fluid Responsiveness During Shock State by End-expiratory Occlusion Test in Newborns and Infants : EVEOC Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock
Keywords
Shock, Invasive mechanical ventilation, Fluid responsiveness, Heart-lung interactions, End-expiratory occlusion test, Newborns and infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
End-expiratory occlusion test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac output
Description
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
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Time Frame
25 minutes
Title
Systolic and diastolic blood pressures and mean arterial pressure
Description
Recorded using a bedside monitor before and during end-expiratory pause and after volume expansion.
Time Frame
25 minutes
Title
Arterial pulse pressure
Description
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
Title
Stroke volume
Description
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Time Frame
25 minutes
Title
Aortic velocity time integral
Description
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Time Frame
25 minutes
Title
Aortic blood flow velocity
Description
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Time Frame
25 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaël LEVY, MD
Phone
1 87 89 26 83
Ext
+33
Email
yael.levy@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène MOREL
Phone
1 71 19 63 46
Ext
+33
Email
helene.morel@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaël LEVY, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Louis LEGER, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Armand Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaël LEVY
Phone
1 87 89 26 83
Ext
+33
Email
yael.levy@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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