Vascular DiseasesNCT04179097
Photoplethysmographic Dichrotic Notch Reflexes Systemic Hemodynamics
An observational study of Vascular Diseases, run by Hospital Privado de Comunidad de Mar del Plata at 2 sites in Argentina.
Trial summary
Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The investigators have previously demonstrated that the shape of the pulse oximetry waveform (photoplethysmography) is closely related to the changes observed in systemic vascular resistence. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Finger photoplethysmography
- How many people
- 15 participants
- Where
- 2 sitesArgentina
- Study dates
- 5 Nov 2019to 10 Aug 2024
- How long will I take part?
- 1 Day
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing regional anesthesia (brachial plexus block) for upper limb surgeries
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
2 sites in 1 country.
Argentina2 sites
Cecilia M. Acosta
Mar del Plata, Buenos Aires, 7600
Hospital Privado de Comunidad
Mar del Plata, Buenos Aires, 7600
About this study
Official title: Dichrotic Notch Positioning in Finger Photoplethysmography Waveform Reflex Systemic Vascular Resistance
Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The investigators have previously demonstrated that the shape of the pulse oximetry waveform (photoplethysmography) is closely related to the changes observed in systemic vascular resistence. The main change in pulse waveform is based to the dichrotic notch position. The present study was designed to determine if the dichrotic notch position is related to a local or a systemic change in the vascular tone.
Read the detailed description
This is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform of surgical patients is related to a local or a sistemic changes in the vascular tone. The investigators will studied 15 patients undergoing regional brachial plexus anesthesia for upper limb surgeries. Photoplethysmography will be continuously recorded in the thumb of the tested hand (anesthetized hand) and in the thumb of the control, opposite hand. Duplex color and power Doppler will measure flow in the both brachial arteries and in the aorta (supraesternal view). The contour analysis of both, photoplethysmogram and arterial flow velocities will be analyzed, correlated and compared.
- Conditions
- Vascular Diseases
- Being tested
- Finger photoplethysmography
- Keywords
- Doppler, Photoplethysmography
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger photoplethysmographyDiagnostic test
Also called Brachial and aorta Doppler
Bilateral finger photoplethysmogray, bilateral brachial artery Doppler, Aorta artery Doppler
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis in the position of the dichrotic notch between photoplethysmogram and spectral Doppler waveforms.
The position of the dichrotic notch of pulse waveform in photoplethysmogram (time arrival of diastolic wave expressed in seconds) was compared to the one observed in the spectral Doppler waveform (seconds).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start5 Nov 2019
- Primary completion1 Aug 2024
- Study completion10 Aug 2024
Why it stopped: COVID pandemic changed completely the surgical schedule and human resources in our hospital. It was impossible to coordinate the anesthesiologists involved in the study with the kind of patients need for this particular study.
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
- 15 participants (actual)
- Target duration
- 1 Day
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, Hospital Privado de Comunidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179097
- Sponsor's protocol ID
- 2919/1942/2019
- Status last verified
- Aug 2024
- First submitted
- 30 Sep 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dichrotic Notch Positioning in Finger Photoplethysmography Waveform Reflex Systemic Vascular Resistance
- ClinicalTrials.gov ID
- NCT04179097
- Acronym / sponsor ID
- 2919/1942/2019
- Conditions
- Vascular Diseases
- Keywords
- Doppler, Photoplethysmography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID pandemic changed completely the surgical schedule and human resources in our hospital. It was impossible to coordinate the anesthesiologists involved in the study with the kind of patients need for this particular study.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 26 Nov 2019 (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.
Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The investigators have previously demonstrated that the shape of the pulse oximetry waveform (photoplethysmography) is closely related to the changes observed in systemic vascular resistence. The main change in pulse waveform is based to the dichrotic notch position. The present study was designed to determine if the dichrotic notch position is related to a local or a systemic change in the vascular tone.
Detailed description
This is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform of surgical patients is related to a local or a sistemic changes in the vascular tone. The investigators will studied 15 patients undergoing regional brachial plexus anesthesia for upper limb surgeries. Photoplethysmography will be continuously recorded in the thumb of the tested hand (anesthetized hand) and in the thumb of the control, opposite hand. Duplex color and power Doppler will measure flow in the both brachial arteries and in the aorta (supraesternal view). The contour analysis of both, photoplethysmogram and arterial flow velocities will be analyzed, correlated and compared.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing regional anesthesia (brachial plexus block) for upper limb surgeries
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger photoplethysmographyAlso: Brachial and aorta DopplerBilateral finger photoplethysmogray, bilateral brachial artery Doppler, Aorta artery Doppler | Diagnostic test | – |
Primary outcome
Analysis in the position of the dichrotic notch between photoplethysmogram and spectral Doppler waveforms.
Time frame: 4 hours
The position of the dichrotic notch of pulse waveform in photoplethysmogram (time arrival of diastolic wave expressed in seconds) was compared to the one observed in the spectral Doppler waveform (seconds).
Results and safety
The study was stopped early (reason given: COVID pandemic changed completely the surgical schedule and human resources in our hospital. It was impossible to coordinate the anesthesiologists involved in the study with the kind of patients need for this particular study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Gerardo Tusman, MD principal investigator
Hospital Privado de Comunidad
2 sites 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 2 sites 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: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: COVID pandemic changed completely the surgical schedule and human resources in our hospital. It was impossible to coordinate the anesthesiologists involved in the study with the kind of patients need for this particular study.). Results are not available in the source record.
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?
Analysis in the position of the dichrotic notch between photoplethysmogram and spectral Doppler waveforms. (time frame: 4 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 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.