Photoplethysmographic Dichrotic Notch Reflexes Systemic Hemodynamics

May 22, 2023 updated by: Hospital Privado de Comunidad de Mar del Plata

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Cecilia M. Acosta
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Hospital Privado de Comunidad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Written Inform Consent
  • Programmed surgery
  • Supine position

Exclusion Criteria:

  • Emergency surgery
  • Peripheral vascular diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Privado de Comunidad de Mar del Plata

Investigators

  • Principal Investigator: Gerardo Tusman, MD, Hospital Privado de Comunidad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2019

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 30, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2919/1942/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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