Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07298720

Acronym

hDOS-CO

Enrollment

200

Registered

2025-12-23

Start date

2025-01-07

Completion date

2027-01-01

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Fluid-responsiveness, Hemodynamic monitoring, Preload-responsiveness, Cardiac output

Brief summary

Proof-of-concept observational study including ICU patients undergoing a PLR maneuver. Local microvasculature will be assessed with the hDOS platform on the brachioradialis muscle, deriving the microvascular blood flow index (BFI) and tissue oxygen saturation (StO2). CO will be assessed via an invasive hemodynamic monitor based on pulse waveform analysis through the patient's arterial line. The correlation over time between CO and microvascular parameters, and the ability of microvascular variables for predicting a positive CO response (increase \> 10%) will be assessed.

Interventions

OTHERPassive Leg Raising maneuver

The PLR will be performed using automatic bed adjustment: Starting from a semi-recumbent position, the lower limbs will be elevated to a 45° angle while the trunk will be moved from semi-recumbent to supine. After three minutes, subjects will be returned to the initial semi-recumbent position.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Invasive blood pressure monitoring through an arterial line

Exclusion criteria

* Patients with suspected pregnancy * Intra-abdominal hypertension * Elevated intracranial pressure

Design outcomes

Primary

Measure	Time frame	Description
Cardiac Output Response	During procedure	The relative increase in % of the Cardiac Output (CO), from baseline during the Passive Leg Raising (PLR) test (at 60-120 seconds within the maneuver), will be calculated. Those subjects with a relative increase equal to or above 10% will be classified as CO-responders to the PLR. On the other hand, if the increase in CO during the PLR is below 10%, subjects will be classified as non-responders.

Countries

Spain

Contacts

CONTACTJaume Mesquida Senior Clinical Researcher, MD

jmesquida@tauli.cat+34 616722287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026