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Clinical Trials/NCT07298720
NCT07298720
Recruiting
Not Applicable

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

Corporacion Parc Tauli1 site in 1 country200 target enrollmentStarted: January 7, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Corporacion Parc Tauli
Enrollment
200
Locations
1
Primary Endpoint
CO Response

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Invasive blood pressure monitoring through an arterial line

Exclusion Criteria

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

Arms & Interventions

Critical care patient

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

Intervention: Passive Leg Raising maneuver (Other)

Outcomes

Primary Outcomes

CO Response

Time Frame: During procedure

The relative increase in % of the CO, from baseline during the PLR (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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Corporacion Parc Tauli
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jaume Mesquida

Senior Clinical Researcher

Corporacion Parc Tauli

Study Sites (1)

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