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NCT02854852 Clinical Trial

Photoplethysmography Detects Changes in Vascular Tone

Vascular Diseases Clinical Trial

Official title:
Accuracy of Photoplethysmography to Detect Changes in Vascular Tone: a Doppler Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02854852
Other study ID # 359/16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2017
Est. completion date January 30, 2018

Study information
Verified date January 2018
Source Hospital Privado de Comunidad de Mar del Plata
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The present study was designed to determine if photoplethysmography can detect changes in the systemic vascular resistance using Doppler as the reference method.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 30, 2018
Est. primary completion date January 22, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Written Inform Consent

- Programmed surgery

- Supine position

Exclusion Criteria:

- Emergency surgery

- Peripheral vascular diseases

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
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 Accuracy of photoplethysmography for the assessment of systemic vascular tone Comparison between pletysmography with the reference Doppler method 5 hours
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