Fluid Therapy, Hemodynamics, Hypovolemia, Shock
Conditions
Keywords
children, critically ill, fluid therapy, fluid responsiveness, hemodynamics, hypovolemia, shock, echocardiography
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.
Interventions
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORSimon Barreault, Doctor
Bicetre Hospital (AP-HP)
Outcome results
None listed