Microcirculation Clinical Trial
Official title:
Evaluation of Microcirculation With Photoplethysmography (Pulse Oximetry) in Healthy Volunteers and Ventilated Patients
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Privado de Comunidad | Mar Del Plata | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Hospital Privado de Comunidad de Mar del Plata |
Argentina,
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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