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Recruiting NCT07298720

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

— Observational Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Passive Leg Raising maneuver.
Who it may be relevant to
Registry conditions: Critical Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • Cardiac Output Response [Time frame: During procedure]

Eligibility criteria

Inclusion criteria

  • Invasive blood pressure monitoring through an arterial line

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Parc Taulí Hospital Universitari — Sabadell

Identifiers

NCT: NCT07298720 · CEIm 2024/3001 · INN2024003 · CIR2023014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗