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

NCT05054452 | Unknown

• 1 other identifier: 2021-A00203-38
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Therapy; Hemodynamics; Hypovolemia; Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiac index measured by transthoracic echocardiography

  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 .

  Through the end of the hospitalisation, a maximum of 2 months

Secondary Outcomes (1)

• End-tidal carbon dioxide levels

  Through the end of the hospitalisation, a maximum of 2 months

Study Arms (1)

Echocardiographic assessment

EXPERIMENTAL

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.

Device: Echocardiographic assessment

Interventions

Echocardiographic assessment 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.

Echocardiographic assessment

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bicetre Hospital

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 18259726 BACKGROUND

MeSH Terms

Conditions

Hypovolemia; Shock; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Simon Barreault, Doctor

  Bicetre Hospital (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Barreault, Doctor

CONTACT

+33145213205; simon.barreault@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: September 23, 2021
• Study Start: June 25, 2021
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: December 8, 2021

Record last verified: 2021-09

Locations

FR (1)