Use of the Aortic Time-velocity Integral Via Suprasternal Ultrasound to Search Preload Dependence in Paediatric Surgery : Kid's Fluid Management (FM)

NCT07099664 | Not Yet Recruiting

• 2 other identifiers: 2023_07082024-A01473-44
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

After major surgery, fluid overload is associated with an increase of morbidity and mortality. Fluid administration should therefore be given wisely. However, there is a paucity of monitor to predict preload dependence in paediatric anaesthesia. The aim of this study is to determine if VTI variation, measured through the suprasternal window, with a cardiac doppler probe, can predict preload dependence. Indeed, cardiac probe are present in most operating room and suprasternal window is reachable in most surgical case, which should allow VTI monitoring for the vast majority of our patient.

Conditions

Hemodynamic

Keywords

Suprasternal doppler; paediatric anaesthesia; hemodynamic; fluid management

Outcome Measures

Primary Outcomes (1)

• Aortic VTI variation (%) measured by suprasternal doppler in percent of mean aortic VTI.

  During preoperative, after induction and fasting compensation, before incision.

Secondary Outcomes (3)

• Proportion of patient (%) in whom we can use suprasternal aortic measurements.

  During preoperative period, after induction and fasting compensation, before incision.

• Optimal threshold of aortic VTI variation (%) measured by suprasternal doppler to determine wether the patient is preload dependant or independent as defined above.

  During preoperative period, after induction and fasting compensation, before incision.

• Correlation between : - fasting duration in hours, determined by patient or parent interrogation. - preload dependence as defined above. More than one outcome measure appears to be described.

  During preoperative period, after induction and fasting compensation, before incision.

Study Arms (1)

Measurement of VTI variation and cardiac output after general anaesthesia.

Measurement of VTI variation and cardiac output after general anaesthesia. Patients responding to volume expansion (more than 10% increase of cardiac output measured by transthoracic ultrasound after a 10ml/kg perfusion of cristalloids)

Diagnostic Test: Measurement of aortic Vmax and VTI with suprasternal doppler.

Interventions

Measurement of aortic Vmax and VTI with suprasternal doppler. DIAGNOSTIC_TEST

Measurement of aortic Vmax and VTI with suprasternal doppler. Measurement of VTI variation and cardiac output after general anaesthesia. After preoperative fasting compensation, measurement of cardiac output (CO). Search of a difference in the suprasternale VTI variability between the patients who have increased their CO after fasting compensation and the patient who haven't.

Measurement of VTI variation and cardiac output after general anaesthesia.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient under 18 admitted to paediatric operating room for a surgical intervention, an endoscopy, an interventional radiology procedure or an imagery and needing a general anaesthesia

You may qualify if:

• Patient under 18 admitted to paediatric operating room for a surgical intervention, an endoscopy, an interventional radiology procedure or an imagery and needing a general anaesthesia.

You may not qualify if:

• Condition preventing a suprasternal ultrasound (tracheostomy, spinal immobilization, suprasternal bandage)
• Pathology disturbing respiratory variation of left ventricular stroke volume (PAH, constrictive pericarditis, pericardial effusion, right ventricular dysfunction, complex congenital heart disease, aortic coarctation, patent ductus arteriosus
• Every medical condition where Berry's rule of fasting compensation could be unsafe (anuric kidney failure, oedema, heart failure with reduce left ventricular ejection fraction, patient under vasoactive drugs
• Opposition to the participation in the study
• Pregnant women
• Patient with no security coverage
• Inability to determine baseline cardiac output

Sponsors & Collaborators

• University Hospital, Lille: lead

Central Study Contacts

Martin DUBERNET, Dr

CONTACT

+33 3 20 44 59 62; Martin.DUBERNET@chu-lille.fr

Julien COROUGE, Dr

CONTACT

+33 3 20 44 59 62; julien.corouge@chu-lille.fr

Study Design

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

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share