MicrocirculationNCT06141681
Evaluation of Microcirculation With Photoplethysmography (Pulse Oximetry) in Healthy Volunteers and Ventilated Patients
An observational study of Microcirculation and Photoplethysmography, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microcirculation, Photoplethysmography
- What is being tested?
- photoplethysmography
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 19 Jun 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers or operating room or intensive care patients- See inclusion and exclusion criteria
Who may be able to join
- Written informed consent.
- Age > 18 years.
- Written informed consent.
- Age > 18 years.
- Critical patients ventilated in the ICU of any origin.
Who cannot join
- Pregnancy.
- Smokers.
- Respiratory and/or cardiovascular pathologies.
- Peripheral vascular disease.
- Operation room or Critical care Unit patients
- Known peripheral vascular disease.
- Burns on both upper limbs.
- Trauma to both upper limbs.
Trial locations and contacts
1 site in 1 country.
Gerarado Tusman, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Privado de Comunidad
Mar del Plata, Buenos Aires, 7600
Nora Fuentes, PhD, +5492234370088, nora.fuentes@hospitalitaliano.org.ar
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Microcirculation, Photoplethysmography
- Being tested
- photoplethysmography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photoplethysmographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | >18 years old healthy Receives: Other: photoplethysmography | |
| Patients in critical care unit | patient in ICU with requirement for hemodynamic monitoring Receives: 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 Receives: Other: photoplethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start19 Jun 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Angélica Fuentes, Hospital Privado de Comunidad de Mar del Plata
- Investigators
- Nora Fuentes, PhD, Principal investigator, Hospital Privado de Comunidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141681
- Sponsor's protocol ID
- UCI-000004
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microcirculation With Photoplethysmography (Pulse Oximetry) in Healthy Volunteers and Ventilated Patients
- ClinicalTrials.gov ID
- NCT06141681
- Acronym / sponsor ID
- UCI-000004
- Conditions
- Microcirculation, Photoplethysmography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: photoplethysmography>18 years old healthy |
| Patients in critical care unit | – | Other: photoplethysmographypatient in ICU with requirement for hemodynamic monitoring |
| Patients with ventilatory support in the operating room or critical care unit | – | Other: photoplethysmographypatient in the ICU or operating room with a requirement for hemodynamic monitoring and ventilatory support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers or operating room or intensive care patients- See inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- Written informed consent.
- Age > 18 years.
- Written informed consent.
- Age > 18 years.
- Critical patients ventilated in the ICU of any origin.
Key exclusion criteria (8 listed)
- Pregnancy.
- Smokers.
- Respiratory and/or cardiovascular pathologies.
- Peripheral vascular disease.
- Operation room or Critical care Unit patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photoplethysmographyPhotoplethysmography (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. | Other | Healthy volunteers, Patients in critical care unit, Patients with ventilatory support in the operating room or critical care unit |
Primary outcome
variations in AC signal of photoplethysmography
Time frame: Through study completion, an average of 1 year
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.
variations in DC signal of photoplethysmography
Time frame: Through study completion, an average of 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerarado Tusman, MD contact
Nora Fuentes, PhD principal investigator
Hospital Privado de Comunidad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcirculation and Photoplethysmography, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nora Fuentes, PhD (+542234370088, nora.fuentes@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variations in AC signal of photoplethysmography (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.