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NCT Number: NCT07298720

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parc Taulí Hospital Universitari

Sabadell, Spain/ Barcelona, 08208, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Invasive blood pressure monitoring through an arterial line

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Cardiac Output Response

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Institut de Ciències Fotòniques (ICFO)

Registry information

Acronym: hDOS-CO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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