Evaluation of Microcirculation With Photoplethysmography (Pulse Oximetry) in Healthy Volunteers and Ventilated Patients

NCT06141681 | Unknown

• 1 other identifier: UCI-000004
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational study is to explore microcirculation in healthy volunteers and in ventilated patients in the operating room and in critical care. The general objective of this study is to evaluate microcirculation with photoplethysmography (PPG) in different pathophysiological situations and to compare PPG with available standard methods. Specifically, evaluate the correlation between the determinations of AC-DC waves obtained by Photoplethysmography (PPG) and those obtained in different dynamic tests in healthy volunteers. To compare microcirculation assessments \[capillary refill time (CRT), perfusion index (PI), perfusion index variability (PIV)\] with measurements obtained by PPG in the context of critically ill patients. To compare microcirculation assessments (CRT, PI PVI) with measurements obtained by PPG in the context of patients on invasive mechanical ventilation (IMV) in the operating room and in critical care.

Conditions

Microcirculation; Photoplethysmography

Outcome Measures

Primary Outcomes (2)

• variations in AC signal of photoplethysmography

  Changes in the AC wave of photoplethysmography (it does not currently have standardized measurement units) will be evaluated in each functional test (CRT, LPR, venous occlusion test, progressive arterial occlusion test). It will be treated as a continuous numerical variable.

  Through study completion, an average of 1 year

• variations in DC signal of photoplethysmography

  Changes in the DC wave of photoplethysmography (it does not currently have standardized measurement units) will be evaluated in each functional test (CRT, LPR, venous occlusion test, progressive arterial occlusion test). It will be treated as a continuous numerical variable.

  Through study completion, an average of 1 year

Study Arms (3)

Healthy volunteers

\>18 years old healthy

Other: photoplethysmography

Patients in critical care unit

patient in ICU with requirement for hemodynamic monitoring

Other: photoplethysmography

Patients with ventilatory support in the operating room or critical care unit

patient in the ICU or operating room with a requirement for hemodynamic monitoring and ventilatory support

Other: photoplethysmography

Interventions

photoplethysmography OTHER

Photoplethysmography (BluePoint, Frankfurt, Germany) is the pulse wave measured by a pulse oximeter. It is obtained based on the absorbance of red/infrared light in a given tissue. The signal is made up of two components: 1) the alternating component (AC), which is the pulse wave itself, which is determined by the absorbance of pulsatile arterial blood. 2) The continuous component (DC), which represents the absorbance of venous blood and the rest of the tissues. Within these tests the investigators find vascular occlusion, elevation of the legs, raising or lowering the tested hand above/below the phlebostatic level, cold/heat test, etc. Each of them evaluates different aspects of circulation such as endothelial function, myogenic response to blood flow, perfusion pressure, autonomic reflexes, preload-dependence, or venous flow among other aspects of microcirculation.

Healthy volunteers; Patients in critical care unit; Patients with ventilatory support in the operating room or critical care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy volunteers or operating room or intensive care patients- See inclusion and exclusion criteria

You may qualify if:

• Written informed consent.
• Age \> 18 years.

You may not qualify if:

• Pregnancy.
• Smokers.
• Respiratory and/or cardiovascular pathologies.
• Peripheral vascular disease.
• Operation room or Critical care Unit patients
• Written informed consent.
• Age \> 18 years.
• Critical patients ventilated in the ICU of any origin.
• Known peripheral vascular disease.
• Burns on both upper limbs.
• Trauma to both upper limbs.

Sponsors & Collaborators

• Hospital Privado de Comunidad de Mar del Plata: lead

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

RECRUITING

Study Officials

• Nora Fuentes, PhD

  Hospital Privado de Comunidad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora Fuentes, PhD

CONTACT

+542234370088; nora.fuentes@hospitalitaliano.org.ar

Gerarado Tusman, MD

CONTACT

gtusman@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 21, 2023
• Study Start: June 19, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

AR (1)