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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06141681
Other study ID # UCI-000004
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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