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

Microcirculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141681
• Other study ID #: UCI-000004
• Status: Recruiting
• Start date: June 19, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: Hospital Privado de Comunidad de Mar del Plata
• Contact: Nora Fuentes, PhD
• Phone: +542234370088
• Email: nora.fuentes[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

An attempt is made to explore different physiological aspects that affect microcirculation such as vascular tone and blood volume.

Photoplethysmography usually examines the AC wave equivalent to the pulsatile wave, however the DC component has been less explored and can account for the microcirculation and volemia status of the subjects.

Since there is no gold standard, it will be compared against different validated methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Healthy Volunteers:

Inclusion Criteria:

• Written informed consent.

• Age > 18 years.

Exclusion Criteria:

• Pregnancy.

• Smokers.

• Respiratory and/or cardiovascular pathologies.

• Peripheral vascular disease.

Operation room or Critical care Unit patients

Inclusion criteria:

• Written informed consent.

• Age > 18 years.

• Critical patients ventilated in the ICU of any origin.

Exclusion criteria:

• Known peripheral vascular disease.

• Burns on both upper limbs.

• Trauma to both upper limbs.

Related Conditions & MeSH terms

• Microcirculation
• Photoplethysmography

Intervention

Other:
• photoplethysmography
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.

Locations

Country	Name	City	State
Argentina	Hospital Privado de Comunidad	Mar Del Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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