NCT04179097

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

4.7 years

First QC Date

September 30, 2019

Last Update Submit

September 2, 2024

Conditions

Vascular Diseases

Keywords

DopplerPhotoplethysmography

Outcome Measures

Primary Outcomes (1)

  • 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).

    4 hours

Interventions

Finger photoplethysmographyDIAGNOSTIC_TEST

Bilateral finger photoplethysmogray, bilateral brachial artery Doppler, Aorta artery Doppler

Also known as: Brachial and aorta Doppler

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing regional anesthesia (brachial plexus block) for upper limb surgeries

You may qualify if:

  • Written Inform Consent
  • Programmed surgery
  • Supine position

You may not qualify if:

  • Emergency surgery
  • Peripheral vascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cecilia M. Acosta

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Gerardo Tusman, MD

    Hospital Privado de Comunidad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

November 26, 2019

Study Start

November 5, 2019

Primary Completion

August 1, 2024

Study Completion

August 10, 2024

Last Updated

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

AR(2)