ShockEVEOCNCT04932590
Predicting Fluid Responsiveness During Shock in Newborns and Infants by End-expiratory Occlusion Test
A study testing End-expiratory occlusion test in people with Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 years
- Conditions the study is for
- Shock
- What is being tested?
- End-expiratory occlusion test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2021to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- End-expiratory occlusion test
- Keywords
- Shock, Invasive mechanical ventilation, Fluid responsiveness, Heart-lung interactions, End-expiratory occlusion test, Newborns and infants
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-expiratory occlusion testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: End-expiratory occlusion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 25 minutes
Secondary outcomes (6)
Heart rate
Heart rate measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Measured: 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.
Measured: 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).
Measured: 25 minutes
Stroke volume
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Measured: 25 minutes
Aortic velocity time integral
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Measured: 25 minutes
Aortic blood flow velocity
Measured by cardiac ultrasound before and during end-expiratory pause and after volume expansion.
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start24 Dec 2021
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yaël LEVY, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisPierre-Louis LEGER, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932590
- Sponsor's protocol ID
- APHP201320
- Other IDs
- ID RCB 2020-A02
- Acronym
- EVEOC
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Fluid Responsiveness During Shock State by End-expiratory Occlusion Test in Newborns and Infants : EVEOC Study
- ClinicalTrials.gov ID
- NCT04932590
- Acronym / sponsor ID
- EVEOC / APHP201320
- Conditions
- Shock
- Keywords
- Shock, Invasive mechanical ventilation, Fluid responsiveness, Heart-lung interactions, End-expiratory occlusion test, Newborns and infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: End-expiratory occlusion testPatients 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. |
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| End-expiratory occlusion testThe 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. | Other | Patients |
Primary outcome
Cardiac output
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%.
6 secondary outcomes
Heart rate
Time frame: 25 minutes
Systolic and diastolic blood pressures and mean arterial pressure
Time frame: 25 minutes
Arterial pulse pressure
Time frame: 25 minutes
Stroke volume
Time frame: 25 minutes
Aortic velocity time integral
Time frame: 25 minutes
Aortic blood flow velocity
Time frame: 25 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaël LEVY, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Pierre-Louis LEGER, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-expiratory occlusion test in people with Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: 25 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.