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

NCT07298720 | Recruiting

• 3 other identifiers: CEIm 2024/3001INN2024003CIR2023014
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiac Output Response

  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.

  During procedure

Study Arms (1)

Critical care patient

Critical care patients with their blood pressure invasively monitored through an arterial line

Other: Passive Leg Raising maneuver

Interventions

Passive Leg Raising maneuver OTHER

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.

Critical care patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients with their blood pressure invasively monitored through an arterial line

You may qualify if:

• Invasive blood pressure monitoring through an arterial line

You may not qualify if:

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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Institut de Ciències Fotòniques (ICFO): collaborator

Study Sites (1)

Parc Taulí Hospital Universitari

Sabadell, Spain/ Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jaume Mesquida Senior Clinical Researcher, MD

CONTACT

+34 616722287; jmesquida@tauli.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Researcher

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 23, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES (1)