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

NCT ID: NCT05054452

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-25
• Study Completion Date: 2023-08-30

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.

Conditions

Fluid Therapy; Hemodynamics; Hypovolemia; Shock

Keywords

children; critically ill; fluid therapy; fluid responsiveness; hemodynamics; hypovolemia; shock; echocardiography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Echocardiographic assessment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient < 18 years (child and neonate)
• Sedated and mechanically ventilated under controlled-mode ventilation
• In whom fluid administration was planned by the attending physicians

Exclusion Criteria

• High-frequency oscillatory ventilation
• Cardiac arrhythmia
• Congenital heart defect

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Barreault, Doctor

Role: PRINCIPAL_INVESTIGATOR

Bicetre Hospital (AP-HP)

Locations

Bicetre Hospital

Le Kremlin-Bicêtre, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Simon Barreault, Doctor

Role: CONTACT

Phone: +33145213205

Email: simon.barreault@aphp.fr

Facility Contacts

Simon BARREAULT, Doctor

Role: primary

References

Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.

Reference Type: BACKGROUND

PMID: 18259726 (View on PubMed)

Other Identifiers

2021-A00203-38

Identifier Type: -

Identifier Source: org_study_id