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

C

Corporacion Parc Tauli

Status

Enrolling

Conditions

Critical Illness

Treatments

Other: Passive Leg Raising maneuver

Study type

Observational

Funder types

Other

Identifiers

NCT07298720
CIR2023014 (Other Grant/Funding Number)
INN2024003 (Other Grant/Funding Number)
CEIm 2024/3001

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Invasive blood pressure monitoring through an arterial line

Exclusion criteria

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

Trial design

200 participants in 1 patient group

Critical care patient
Description:
Critical care patients with their blood pressure invasively monitored through an arterial line
Treatment:
Other: Passive Leg Raising maneuver

Trial contacts and locations

1

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Central trial contact

Jaume Mesquida Senior Clinical Researcher, MD

Data sourced from clinicaltrials.gov

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