Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients

NCT04186416 | Recruiting

• 2 other identifiers: APHP1910362019-A02804-53
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system. The objectives of the study are to determine if the parameters measured by Mostcare® make it possible to predict the response to volume expansion in pediatric surgical critical care patients, sedated, intubated and ventilated, by comparing the changes in stroke volume, induced by a volume expansion, measured by trans-thoracic echocardiography.

Conditions

Hypovolemia; Hemorrhage; Fluid Responsiveness

Keywords

Volume expansion in children; Mostcare® device; Fluid responsiveness; Stroke volume; Transthoracic cardiac echocardiography

Outcome Measures

Primary Outcomes (1)

• Stroke volume variation from Mostcare®

  Predictability of stroke volume variation (SVV) from Mostcare® for fluid responsiveness. Patients are defined as responders if stroke volume obtained using echocardiography increased by ≥15% after volume expansion.

  5 minutes after infusion of bolus fluid

Secondary Outcomes (2)

• Absolute values and variation of cardiac output (CO) and cardiac index (CI) from Mostcare®

  5 minutes after infusion of bolus fluid

• Absolute values and variation of stroke volume (SV) and indexed stroke volume (SVi) from Mostcare®

  5 minutes after infusion of bolus fluid

Study Arms (4)

Patients less than 6 months old

Patients less than 6 months old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.

Other: Mostcare® device; Other: Transthoracic cardiac ultrasound

Patients between 6 and 12 months old

Patients between 6 and 12 months old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.

Other: Mostcare® device; Other: Transthoracic cardiac ultrasound

Patients between 1 and 6 years old

Patients between 1 and 6 years old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.

Other: Mostcare® device; Other: Transthoracic cardiac ultrasound

Patients between 6 and 10 years old

Patients between 6 and 10 years old admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.

Other: Mostcare® device; Other: Transthoracic cardiac ultrasound

Interventions

Mostcare® device OTHER

The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.

Patients between 1 and 6 years old; Patients between 6 and 10 years old; Patients between 6 and 12 months old; Patients less than 6 months old

Transthoracic cardiac ultrasound OTHER

Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.

Patients between 1 and 6 years old; Patients between 6 and 10 years old; Patients between 6 and 12 months old; Patients less than 6 months old

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients between birth and 10 years of age admitted to the pediatric surgical ICU of the Necker-Enfants Malades university hospital and for whom volume expansion is indicated.

You may qualify if:

• Children aged 0 to 10 years old, of both sexes.
• Perioperative period of surgery under general anesthesia requiring admission to surgical resuscitation (before and / or after the surgical procedure).
• Patients admitted for severe trauma.
• Patient installation: supine position.
• Intubation and mechanical ventilation: tidal volume: 7 to 8 ml / kg, Positive expiratory pressure : 3-4 cm H2O, inspiration / expiration: 1 / 1.5 to 1/2; respiratory rate: 1 month up to 2 years = 30 / min; children 2-8 years = 20 / min; children\> 8 years = 15 / min.
• Patients with arterial catheters.
• Need for a volume expansion : indication given by the doctor in charge of the patient.
• Non-opposition expressed by the holders of parental authority.

You may not qualify if:

• Cardiopathy: severe systolic dysfunction (shortening fraction \<28%, ejection fraction \<50%); valvulopathy (significant narrowing or valvular insufficiency); left-right shunt, persistent arterial duct.
• Unstable hemodynamic status related to active bleeding requiring vascular filling \> 2 mL / kg / min or requiring vasopressor or inotropic therapy whose dosage had to be changed in the last five minutes.
• Need for mechanical ventilation with a tidal volume\> 10 mL / kg or \<7 mL / kg.
• Refusal of the patient or the holders of parental authority to exploit the collected data.
• Impossibility to carry out measurements.

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Hypovolemia; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilles Orliaguet, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Estelle Vergnaud, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Gilles Orliaguet, MD, PhD

CONTACT

+33 1 44 49 44 58; gilles.orliaguet@aphp.fr

Hélène Morel

CONTACT

+33 1 71 19 63 46; helene.morel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: May 3, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)