Vascular DiseasesNCT02854852
Photoplethysmography Detects Changes in Vascular Tone
An observational study of Vascular Diseases, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
Trial summary
Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The monitoring of such changes in vascular resistance using simple and non-invasive tools is lacking. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Vascular Diseases
- How many people
- 50 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Mar 2017to 30 Jan 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing general anesthesia
Who may be able to join
- Written Inform Consent
- Programmed surgery
- Supine position
Who cannot join
- Emergency surgery
- Peripheral vascular diseases
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Privado de Comunidad
Mar del Plata, Buenos Aires, 7600
About this study
Official title: Accuracy of Photoplethysmography to Detect Changes in Vascular Tone: a Doppler Study
Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The monitoring of such changes in vascular resistance using simple and non-invasive tools is lacking. The present study was designed to determine if photoplethysmography can detect changes in the systemic vascular resistance using Doppler as the reference method.
Read the detailed description
This is a prospective and observational study designed to test the reliability of photoplethysmography to diagnose changes in the vascular resistance during anesthesia. The investigators will studied 50 mechanically ventilated patients undergoing general anesthesia. Photoplethysmography will be continuously recorded in the right thumb during anesthesia. Duplex color and power Doppler will measure flow in the radial artery of the right hand.The contour analysis of both, photoplethysmogram and radial artery flow will be analyzed, correlated and compared using the Bland-Altman plot.
- Conditions
- Vascular Diseases
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing general anesthesia | Patients ASA 1-3, undergoing different types of general anesthesia, in supine position, with standard or advanced hemodynamic monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of photoplethysmography for the assessment of systemic vascular tone
Comparison between pletysmography with the reference Doppler method
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start15 Mar 2017
- Primary completion22 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerardo Tusman, MD, Principal investigator, Study Principal Investigato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854852
- Sponsor's protocol ID
- 359/16
- Status last verified
- Jan 2018
- First submitted
- 1 Aug 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Photoplethysmography to Detect Changes in Vascular Tone: a Doppler Study
- ClinicalTrials.gov ID
- NCT02854852
- Acronym / sponsor ID
- 359/16
- Conditions
- Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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.
Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The monitoring of such changes in vascular resistance using simple and non-invasive tools is lacking. The present study was designed to determine if photoplethysmography can detect changes in the systemic vascular resistance using Doppler as the reference method.
Detailed description
This is a prospective and observational study designed to test the reliability of photoplethysmography to diagnose changes in the vascular resistance during anesthesia. The investigators will studied 50 mechanically ventilated patients undergoing general anesthesia. Photoplethysmography will be continuously recorded in the right thumb during anesthesia. Duplex color and power Doppler will measure flow in the radial artery of the right hand.The contour analysis of both, photoplethysmogram and radial artery flow will be analyzed, correlated and compared using the Bland-Altman plot.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing general anesthesia | – | –Patients ASA 1-3, undergoing different types of general anesthesia, in supine position, with standard or advanced hemodynamic monitoring. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing general anesthesia
Key inclusion criteria (3 listed)
- Written Inform Consent
- Programmed surgery
- Supine position
Key exclusion criteria (2 listed)
- Emergency surgery
- Peripheral vascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of photoplethysmography for the assessment of systemic vascular tone
Time frame: 5 hours
Comparison between pletysmography with the reference Doppler method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Vascular Diseases
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
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.
Gerardo Tusman, MD principal investigator
Study Principal Investigato
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 Vascular Diseases, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of photoplethysmography for the assessment of systemic vascular tone (time frame: 5 hours). 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 3 Oct 2018.