Non-invasive forearm optical monitoring to predict fluid response in critically ill patients
Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle
This study will try to see if a non-invasive optical sensor placed on the forearm can predict which critically ill patients will have their cardiac output increase after a passive leg-raising test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Corporacion Parc Tauli Academic / other |
| Locations | 1 site (Sabadell, Spain/ Barcelona) |
| Trial ID | NCT07298720 on ClinicalTrials.gov |
What this trial studies
This proof-of-concept observational study enrolls ICU patients undergoing a passive leg-raising (PLR) maneuver to provoke transient changes in preload. A hybrid diffuse optics (hDOS) probe is placed on the brachioradialis muscle to record microvascular blood flow index (BFI) and tissue oxygen saturation (StO2) while cardiac output (CO) is measured continuously from an arterial-line based pulse waveform monitor. Investigators will examine correlations over time between CO and the microvascular variables and determine whether changes in BFI or StO2 predict a positive CO response (>10% increase). Enrollment and measurements occur at a single center in Sabadell, Spain, for proof-of-concept performance rather than direct clinical decision-making.
Who should consider this trial
Good fit: Critically ill adults in the ICU who have an arterial line and are undergoing a passive leg-raising assessment and who do not meet exclusion criteria such as pregnancy, intra-abdominal hypertension, or elevated intracranial pressure.
Not a fit: Patients without an arterial line, non-ICU patients, pregnant patients, and those with intra-abdominal hypertension or raised intracranial pressure are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide a bedside, non-invasive way to identify who is likely to benefit from fluids, reducing unnecessary fluid administration and its complications.
How similar studies have performed: Prior work combining passive leg raising with arterial waveform CO and peripheral vascular/near-infrared measurements has shown promise, but using hybrid diffuse optics on muscle is novel and remains at the proof-of-concept stage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Invasive blood pressure monitoring through an arterial line Exclusion Criteria: * Patients with suspected pregnancy * Intra-abdominal hypertension * Elevated intracranial pressure
Where this trial is running
Sabadell, Spain/ Barcelona
- Parc Taulí Hospital Universitari — Sabadell, Spain/ Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Jaume Mesquida Senior Clinical Researcher, MD
- Email: jmesquida@tauli.cat
- Phone: +34 616722287
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.