Using right-sided (sub-pulmonary) Doppler changes on echo to see who needs a fluid bolus
Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness Prospective Observational Study
This research will test whether changes in the sub-pulmonary velocity-time integral on ultrasound during leg-raising or a mini fluid challenge can tell if a critically ill adult with suspected low blood volume will respond to a fluid bolus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 205 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Nord Academic / other |
| Locations | 2 sites (Marseille 15 and 1 other locations) |
| Trial ID | NCT07202637 on ClinicalTrials.gov |
What this trial studies
This is an observational ICU study that compares changes in sub-pulmonary VTI measured from parasternal short-axis or subcostal windows with sub-aortic VTI changes during a passive leg raise or mini-fluid challenge. Patients with suspected hypovolemia or receiving vasopressors undergo bedside echocardiography before and after maneuvers, and a fluid bolus is given per protocol. The design aims to validate sub-pulmonary VTI as an alternative index when aortic VTI measurements are not feasible due to poor echogenicity. Standard exclusions include severe left or right ventricular dysfunction, arrhythmia, pregnancy, intracranial hypertension, abdominal compartment syndrome, amputations, and minors.
Who should consider this trial
Good fit: Adult ICU patients with suspected hypovolemia or on vasopressors who have measurable sub-pulmonary VTI (parasternal short-axis or subcostal) and measurable sub-aortic VTI before and after a passive leg raise are ideal candidates.
Not a fit: Patients with severe LV or RV dysfunction, cardiac arrhythmias, abdominal compartment syndrome, intracranial hypertension, lower-limb amputations, pregnancy, minors, or those without usable echocardiographic windows are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this could provide clinicians with an alternative bedside ultrasound measure to guide fluid therapy in patients who cannot have reliable aortic VTI measurements.
How similar studies have performed: Sub-aortic VTI changes during passive leg raising are established predictors of fluid responsiveness, while the use of sub-pulmonary VTI is relatively novel and has only limited prior validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with measurable sub-pulmonary VTI in at least one of the two windows: parasternal short-axis or subcostal. * Patient with measurable sub-aortic VTI in apical 4-chamber view before and after PLR maneuver. * Patient with suspected hypovolemia or whose hemodynamic status justifies vasopressor infusion. Exclusion Criteria: * Severe left ventricular dysfunction defined by left ventricular ejection fraction (LVEF) \< 30%. * Severe right ventricular dysfunction defined by TAPSE \< 12 mm. * Cardiac arrhythmia or atrial fibrillation. * Abdominal compartment syndrome. * Amputation of one or both lower limbs. * Intracranial hypertension. * Pregnant women (ruled out by systematic pregnancy test at ICU admission). * Minors.
Where this trial is running
Marseille 15 and 1 other locations
- Service de réanimation polyvalente - Hopital Nord — Marseille 15, France (Recruiting)
- Hopital Caremeau Nimes — Nîmes, France (Recruiting)
Study contacts
- Study coordinator: Gary DUCLOS, MD, MSc
- Email: gary.duclos@ap-hm.fr
- Phone: +33 4919665531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.