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

NCT ID: NCT07298720

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-07

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness

Keywords

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Fluid-responsiveness Hemodynamic monitoring Preload-responsiveness Cardiac output

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critical care patient

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

Passive Leg Raising maneuver

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Invasive blood pressure monitoring through an arterial line

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Ciències Fotòniques (ICFO)

UNKNOWN

Sponsor Role collaborator

Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Jaume Mesquida

Senior Clinical Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Parc Taulí Hospital Universitari

Sabadell, Spain/ Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jaume Mesquida Senior Clinical Researcher, MD

Role: CONTACT

Phone: +34 616722287

Email: [email protected]

Facility Contacts

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Jaume Mesquida Senior Clinical Researcher, MD

Role: primary

Other Identifiers

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CEIm 2024/3001

Identifier Type: -

Identifier Source: org_study_id

INN2024003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIR2023014

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id