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

NCT ID: NCT07099664

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Measurement of aortic Vmax and VTI with suprasternal doppler.

Intervention Type: 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.

Interventions

Measurement of aortic Vmax and VTI with suprasternal doppler.

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Martin DUBERNET, Dr

Role: CONTACT

Martin.DUBERNET@chu-lille.fr

+33 3 20 44 59 62

Julien COROUGE, Dr

Role: CONTACT

julien.corouge@chu-lille.fr

+33 3 20 44 59 62

Other Identifiers

2024-A01473-44

Identifier Type: OTHER

Identifier Source: secondary_id

2023_0708

Identifier Type: -

Identifier Source: org_study_id