AzTrials
AzTrials

Echocardiography in Intubated Children in Pediatric Intensive CarePVCECHONCT05195424

Estimation of Central Venous Pressure by Echocardiography in Intubated Children in Pediatric Intensive Care

An observational study of Echocardiography in Intubated Children in Pediatric Intensive Care and Intubation Complication, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Central venous pressure (CVP) is a parameter used very regularly in pediatric resuscitation units. According to international recommendations, it should be measured during resuscitation of acute circulatory failure, severe head trauma, renal transplantation in low weight children, or to indirectly assess systolic… Read more about this study

Who is it for?
Ages 2 days to 12 years
What is being tested?
Estimation of central venous pressure by echocardiography in intubated children in pediatric intensive care
How many people
120 participants
Where
1 siteFrance
Study dates
3 Nov 2021to 3 Nov 2022
Phase
Observational
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 2 days to 12 years
  • All sexes
  • Child

Study population: Intubated pediatric patients in an PICU

Who may be able to join

  • Newborns and children from 2 days post term to 12 years Mechanical ventilation
  • Carriers of a central venous catheter in the superior vena cava and ending in the right atrium"

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

France1 site
  • Robert Debre Hospital

    Paris, 75019

Other trials in France

About this study

Official title: Estimation of Central Venous Pressure by Echocardiography in Intubated Children in Pediatric Intensive Care: a Prospective Multicenter Study

Central venous pressure (CVP) is a parameter used very regularly in pediatric resuscitation units. According to international recommendations, it should be measured during resuscitation of acute circulatory failure, severe head trauma, renal transplantation in low weight children, or to indirectly assess systolic pulmonary artery pressure by the tricuspid leak gradient. The baseline measurement should be performed using a central venous catheter placed at the right atrial outlet. However, in clinical practice, trans-thoracic echocardiography (TTE) is the most widely used hemodynamic examination in PRU because of its simplicity of use and the excellent echogenicity of patients. While this technique allows assessment of CVP in spontaneously ventilated adults, it is not recommended in positively ventilated adults. Similarly, no pediatric study has formally demonstrated that TTE parameters allow reliable estimation of CVP in mechanically ventilated children, who represent a significant proportion of patients hospitalized in PRUs. The investigators therefore propose to validate TTE assessment of CVP in children on MV in PRU.

The investigators wish to carry out a prospective, non-interventional study over 12 months in 6 pediatric intensive care units in France. The main objective will be to study the correlation between the measurement of the collapsibility index, the distensibility index of the inferior vena cava and the ratio of the maximum diameter of the IVC to the diameter of the abdominal aorta with the measurement of the CVP.

Read more

When a patient meets the inclusion criteria, oral information and a paper record will be given to the parental authority holders by the investigator or a physician representing the investigator. After a reflection period of at least 3 hours, the non-objection will be sought and noted in the file. The patient will then be managed according to standard ICU care. The CVP measurements and ultrasound parameters, collected as part of the study, must be carried out in succession, without modifying the ventilator settings or the current therapies.

The first step will be to measure the CVP on 3 occasions, at 30 second intervals, checking for the absence of spontaneous respiration or extra systole that has modified the appearance of the curve. The 2nd step will be to perform the cardiac ultrasound with measurements taken 3 times, at 30 second intervals, repositioning the ETT probe each time.

The investigators hypothesize that the cardiac ultrasound allows to estimate the central venous pressure in pediatric patients, intubated and ventilated in positive pressure thanks to the measurement of these parameters. If confirmed, this data would allow validation of CVP estimation via a simple and noninvasive examination in children in VM. Furthermore, according to the recommendations, the examination of CVP via the catheter requires strict criteria on the position of the catheter (in the superior vena cava territory and at the right atrial junction). Estimation of CVP via ultrasound would therefore make it possible to obtain this data in patients whose catheter does not respect the required position, particularly patients with a catheter in the lower territory.

Read the detailed description

Central venous pressure (CVP) is a parameter used very regularly in pediatric resuscitation units. According to international recommendations, it should be measured during resuscitation of acute circulatory failure, severe head trauma, renal transplantation in low weight children, or to indirectly assess systolic pulmonary artery pressure by the tricuspid leak gradient. The baseline measurement should be performed using a central venous catheter placed at the right atrial outlet. However, in clinical practice, trans-thoracic echocardiography (TTE) is the most widely used hemodynamic examination in PRU because of its simplicity of use and the excellent echogenicity of patients. While this technique allows assessment of CVP in spontaneously ventilated adults, it is not recommended in positively ventilated adults. Similarly, no pediatric study has formally demonstrated that TTE parameters allow reliable estimation of CVP in mechanically ventilated children, who represent a significant proportion of patients hospitalized in PRUs. The investigators therefore propose to validate TTE assessment of CVP in children on MV in PRU.

The investigators wish to carry out a prospective, non-interventional study over 12 months in 6 pediatric intensive care units in France. The main objective will be to study the correlation between the measurement of the collapsibility index, the distensibility index of the inferior vena cava and the ratio of the maximum diameter of the IVC to the diameter of the abdominal aorta with the measurement of the CVP.

When a patient meets the inclusion criteria, oral information and a paper record will be given to the parental authority holders by the investigator or a physician representing the investigator. After a reflection period of at least 3 hours, the non-objection will be sought and noted in the file. The patient will then be managed according to standard ICU care. The CVP measurements and ultrasound parameters, collected as part of the study, must be carried out in succession, without modifying the ventilator settings or the current therapies.

The first step will be to measure the CVP on 3 occasions, at 30 second intervals, checking for the absence of spontaneous respiration or extra systole that has modified the appearance of the curve. The 2nd step will be to perform the cardiac ultrasound with measurements taken 3 times, at 30 second intervals, repositioning the ETT probe each time.

The investigators hypothesize that the cardiac ultrasound allows to estimate the central venous pressure in pediatric patients, intubated and ventilated in positive pressure thanks to the measurement of these parameters. If confirmed, this data would allow validation of CVP estimation via a simple and noninvasive examination in children in VM. Furthermore, according to the recommendations, the examination of CVP via the catheter requires strict criteria on the position of the catheter (in the superior vena cava territory and at the right atrial junction). Estimation of CVP via ultrasound would therefore make it possible to obtain this data in patients whose catheter does not respect the required position, particularly patients with a catheter in the lower territory.

Being tested
Estimation of central venous pressure by echocardiography in intubated children in pediatric intensive care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estimation of central venous pressure by echocardiography in intubated children in pediatric intensive careDiagnostic test

    Estimation of central venous pressure by echocardiography in intubated children in pediatric intensive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The correlation between the measurement of the Collapsibility Index, the Distensibility Index of the inferior vena cava and the ratio of the maximum diameter of the IVC to the diameter of the Abdominal Aorta with the measurement of the CVP.

    Correlation coefficient value between CI, DI, and IVC dmax /AO measurements and reference method CVP measurement

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2022
  2. Study start3 Nov 2021
  3. Primary completion3 Nov 2022
  4. Study completion3 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195424
Sponsor's protocol ID
APHP21
Acronym
PVCECHO
Status last verified
Nov 2026
First submitted
4 Jan 2022
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • See P, Hayotte A, Le Roux E, Guilbert AS, Collignon C, Denante S, Klifa R, Rambaud J, Brissaud O, Dauger S. Estimation of Central Venous Pressure Using Cardiac Ultrasound of Inferior Vena Cava in Ventilated Children: A Prospective Multicenter Observational Study, 2021-2023. Pediatr Crit Care Med. 2025 Dec 1;26(12):e1421-e1426. doi: 10.1097/PCC.0000000000003834. Epub 2025 Sep 29.

    PubMed 41020643

Questions about this trial

What is this clinical trial studying?

An observational study of Echocardiography in Intubated Children in Pediatric Intensive Care and Intubation Complication, 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 2 inclusion and 1 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 6 Nov 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?

The correlation between the measurement of the Collapsibility Index, the Distensibility Index of the inferior vena cava and the ratio of the maximum diameter of the IVC to the diameter of the Abdominal Aorta with the measurement of the CVP. (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05195424, which also lists 1 linked publication.

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 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in