Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography

Not Applicable

• Conditions: Shock; Fluid Therapy; Hemodynamics; Hypovolemia
• Interventions: Device: Echocardiographic assessment

• Registration Number: NCT05054452
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Initial fluid resuscitation remains the first treatment step for most children experiencing circulatory failure and/or systemic hypotension. Only one-half of these patients respond to fluid administration by a significant increase in cardiac output. A positive fluid balance is a poor prognostic factor that increases mortality. There are few markers validated in children to assess volume reactivity by dynamic ultrasound parameters mainly based on heart-lung interaction.

In this work, the investigators propose to investigate whether dynamic parameters validated in adults, such as the superior vena caval collapsibility and the variability of cardiac output during an end-expiratory and end-inspiratory occlusion, are also reliable indicators of volume responsiveness in sedated children under controlled-mode ventilation.

Detailed Description

After standardized volume expansion, patients who present an increase of cardiac index measured by transthoracic echocardiography greater than or equal to 15% of baseline measurement will be considered responders .

A previous similar study using respiratory variations in aortic blood flow to predict fluid responsiveness in ventilated children reported a ROC curve area 0.85, while the prevalence rate of circulatory failure was 50%. Given these assumptions, a sample size of 38 subjects per group (Responders / No responders) was estimated to provide a AUC equivalent. A total of 76 subjects should be included.

Study Timeline

• Study First Submitted: 2021-06-21
• Study Start: 2021-06-25
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-09-23
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-08
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Echocardiographic assessment	Echocardiographic assessment	At baseline before standardized volume expansion, a first set of echocardiographic measurements will be performed. Then, we will perform 15-second end-expiratory and end-inspiratory occlusions. Occlusions will be separated by 1 minute to allow the cardiac index to return to its baseline value. A last set of measurements will be performed after fluid administration. Ventilatory settings and other treatments will remain unchanged during the study period.

Primary Outcome Measures

Name	Time	Method
Cardiac index measured by transthoracic echocardiography	Through the end of the hospitalisation, a maximum of 2 months	After fluid administration, patients who present an increase of cardiac index measured by transthoracic echocardiography greater than or equal to 15% of baseline measurement will be considered responders .

Secondary Outcome Measures

Name	Time	Method
End-tidal carbon dioxide levels	Through the end of the hospitalisation, a maximum of 2 months	ETCO2 measurements using sidestream microstream technology before and after fluid administration will be compared to cardiac index measured by transthoracic echocardiography, ETCO2 increment of 5% is expected in responders patients.

Trial Locations

Locations (1)

Bicetre Hospital; 🇫🇷 Le Kremlin-Bicêtre, France