Photoplethysmography Detects Changes in Vascular Tone | NCT02854852

Studies
Photoplethysmography Detects Changes in Vascular Tone

NCT02854852

Sponsor

Hospital Privado de Comunidad de Mar del Plata

Status

Completed

Last Update Posted

Oct 3, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Vascular Diseases

Interventions

Not provided

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2017Actual

Primary Completion Date

Jan 22, 2018Actual

Completion Date

Jan 30, 2018Actual

First Submitted Date

Aug 1, 2016

First Submission Date that Met QC Criteria

Aug 3, 2016

First Posted Date

Aug 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2018

Last Update Posted Date

Oct 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of photoplethysmography for the assessment of systemic vascular tone	Comparison between pletysmography with the reference Doppler method	5 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written Inform Consent
Programmed surgery
Supine position

Exclusion Criteria:

Emergency surgery
Peripheral vascular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerardo Tusman, MD	Study Principal Investigato	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Privado de Comunidad		Mar del Plata	Buenos Aires	7600	Argentina

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided