NCT02854852

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

October 3, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

August 1, 2016

Last Update Submit

October 1, 2018

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Accuracy of photoplethysmography for the assessment of systemic vascular tone

    Comparison between pletysmography with the reference Doppler method

    5 hours

Study Arms (1)

Patients undergoing general anesthesia

Patients ASA 1-3, undergoing different types of general anesthesia, in supine position, with standard or advanced hemodynamic monitoring.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing general anesthesia

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 (1)

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

    Study Principal Investigato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 4, 2016

Study Start

March 15, 2017

Primary Completion

January 22, 2018

Study Completion

January 30, 2018

Last Updated

October 3, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)