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NCT04179097 Clinical Trial

Photoplethysmographic Dichrotic Notch Reflexes Systemic Hemodynamics

Vascular Diseases Clinical Trial

Official title:
Dichrotic Notch Positioning in Finger Photoplethysmography Waveform Reflex Systemic Vascular Resistance

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04179097
Other study ID # 2919/1942/2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 5, 2019
Est. completion date December 31, 2023

Study information
Verified date May 2023
Source Hospital Privado de Comunidad de Mar del Plata
Contact Gerardo Tusman, MD
Phone 54-223-4990074
Email gtusman@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date December 31, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Written Inform Consent - Programmed surgery - Supine position Exclusion Criteria: - Emergency surgery - Peripheral vascular diseases

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Finger photoplethysmography
Bilateral finger photoplethysmogray, bilateral brachial artery Doppler, Aorta artery Doppler

Locations
Country Name City State
Argentina Cecilia M. Acosta Mar del Plata Buenos Aires
Argentina Hospital Privado de Comunidad Mar del Plata Buenos Aires

Sponsors (1)
Lead Sponsor Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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