Stima della pressione venosa centrale mediante ecocardiografia nei bambini intubati in terapia intensiva pediatrica (PVCECHO)
Stima della pressione venosa centrale mediante ecocardiografia nei bambini intubati in terapia intensiva pediatrica: uno studio prospettico multicentrico
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Contatti e Sedi
Luoghi di studio
-
-
-
Paris, Francia, 75019
- Robert Debre Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Intubated pediatric patients in an PICU
Descrizione
Inclusion Criteria:
- 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"
Exclusion Criteria:
-
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 1 day
|
Correlation coefficient value between CI, DI, and IVC dmax /AO measurements and reference method CVP measurement |
1 day
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Perrine SEE, MD, Assistace Publique Hopitaux de Paris
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- APHP21
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