Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle (hDOS-CO)

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness
• Intervention / Treatment: Other: Passive Leg Raising maneuver

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jaume Mesquida Senior Clinical Researcher, MD; Phone Number: +34 616722287; Email: jmesquida@tauli.cat

Study Locations

• Spain
  • Spain/ Barcelona
    • Sabadell, Spain/ Barcelona, Spain, 08208
      • Recruiting
      • Parc Tauli Hospital Universitari
      • Contact: Jaume Mesquida Senior Clinical Researcher, MD; Phone Number: +34 616722287; Email: jmesquida@tauli.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Invasive blood pressure monitoring through an arterial line

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critical care patient; Critical care patients with their blood pressure invasively monitored through an arterial line	Other: Passive 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Institut de Ciències Fotòniques (ICFO)

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac output; Hemodynamic monitoring; Fluid-responsiveness; Preload-responsiveness
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: CEIm 2024/3001; INN2024003 (Other Grant/Funding Number: Institut d'Investigació i Innovació Parc Taulí); CIR2023014 (Other Grant/Funding Number: Institut d'Investigació i Innovació Parc Taulí)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No