Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients (MOSTCARE-PED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhage; Hypovolemia; Fluid Responsiveness
• Intervention / Treatment: Other: Mostcare® device; Other: Transthoracic cardiac ultrasound

Detailed Description

Children undergoing major surgery or severe trauma with bleeding require regular hemodynamic evaluation, including cardiac output measurement, to maintain adequate organ perfusion. In fact, administration of fluid to improve cardiac output is the mainstay of hemodynamic resuscitation. However, not all patients respond to fluid therapy, and excessive fluid administration is harmful. Therefore, the vascular filling strategy requires a thorough hemodynamic evaluation.

Many predictive tools for fluid responsiveness have been validated in adults, and are based on heart-lung interaction in ventilated patients. Up to now, respiratory variation in aortic blood flow peak velocity, measured by transthoracic or transoesophageal cardiac echocardiography, is the only variable shown to effectively predict fluid responsiveness in children.

However, the use of these methods does not allow continuous monitoring (trans-thoracic echocardiography) or is not easily achievable in current practice (trans-esophageal echocardiography). In addition, these monitoring tools require learning and inter- and intra-individual variability is not negligible, ranging from 1% to 20%.

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 of 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 goal of this study is to assess the ability of dynamic cardiovascular variables measured using Mostcare® to predict fluid responsiveness in pediatric surgical critical care patients, sedated, intubated and ventilated, in prone position, by comparing the changes in stroke volume (SV), induced by a volume expansion (VE), measured by trans-thoracic echocardiography. For the purpose of the study, responders (Rs) to VE are patients showing an increase in SV measured using transthoracic echocardiography of at least 15% after VE.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gilles Orliaguet, MD, PhD; Phone Number: +33 1 44 49 44 58; Email: gilles.orliaguet@aphp.fr
• Study Contact Backup: Name: Hélène Morel; Phone Number: +33 1 71 19 63 46; Email: helene.morel@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hopital Necker-Enfants Malades
    • Contact: Gilles Orliaguet, MD, PhD; Phone Number: +33 1 44 49 44 58; Email: gilles.orliaguet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Cardiac rhythm disorders (in particular atrial fibrillation, junctional tachycardia, ventricular arrhythmias), with the exception of sinus tachycardia, respiratory variations of heart rate and sporadic atrial / ventricular extrasystoles whom will allow inclusion.
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.; Other: Transthoracic cardiac ultrasound; Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.
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; The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.; Other: Transthoracic cardiac ultrasound; Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.
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; The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.; Other: Transthoracic cardiac ultrasound; Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.
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; The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.; Other: Transthoracic cardiac ultrasound; Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute values and variation of cardiac output (CO) and cardiac index (CI) from Mostcare®	Correlation with CO and CI measured by transthoracic cardiac ultrasound before and after volume expansion.	5 minutes after infusion of bolus fluid
Absolute values and variation of stroke volume (SV) and indexed stroke volume (SVi) from Mostcare®	Correlation with SV and SVi by transthoracic cardiac ultrasound before and after volume expansion.	5 minutes after infusion of bolus fluid

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Gilles Orliaguet, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Estelle Vergnaud, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Fluid responsiveness; Volume expansion in children; Mostcare® device; Stroke volume; Transthoracic cardiac echocardiography
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hypovolemia
• Other Study ID Numbers: APHP191036; 2019-A02804-53 (Other Identifier: IDRCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No