The Application of the ELFI-TECH Monitor for Perioperativ... | NCT02628431

Studies
The Application of the ELFI-TECH Monitor for Perioperative Hemodynamic Measurements

NCT02628431

Sponsor

Leiden University Medical Center

Status

Completed

Last Update Posted

Sep 17, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Colon Carcinima

Interventions

Elfi tech monitor

Countries

Netherlands

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

Sep 2019

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

Oct 2015

Primary Completion Date

Sep 1, 2016Actual

Completion Date

Jan 1, 2017Actual

First Submitted Date

Dec 6, 2015

First Submission Date that Met QC Criteria

Dec 8, 2015

First Posted Date

Dec 11, 2015Estimated

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

Sep 13, 2019

Last Update Posted Date

Sep 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Albert Dahan, MD, PhD, Professor, Leiden University Medical CenterPrincipal Investigator

Lead Sponsor

Leiden University Medical CenterOTHER

Collaborators

Not provided

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

The elfitor device is a small non invasive device that uses dynamic light scattering to measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this study, the investigators will investigate whether the elfitor device is able to detect changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the investigators will investigate changes in cutanuous blood flow in different parts of the body during peripheral nerve or neuraxial block.Being able to monitor these entities, under- and overdosing of general and local anesthetics may be prevented, resulting in favorable hemodynamics and better intra and postoperative pain relieve.

Detailed Description

Not provided

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General anesthesia		Patients that will recieve general anesthesia for elective surgery	Device: Elfi tech monitor
Regional or neuraxial anesthesia		Patients that will revieve regional or neuraxial anesthesia for elective surgery	Device: Elfi tech monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elfi tech monitor	Device		General anesthesia Regional or neuraxial anesthesia	Elfitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure	bloodpressure will be compared using conventional techniques and elfitor	up to 1 day
Neuraxial block	neuraxial block will be compared using conventional techniques and elfitor	up to 1 day

Secondary Outcomes

Measure	Description	Time Frame
Cardiac output	during induction of anesthesia the effect of anesthetics or neuraxial blok on cardiac output will be recorded	up to 1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any elective surgery under general or neuraxial anesthesia

Exclusion Criteria:

non elective procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ASA 1-3 patients presenting for elective surgery under general or neuraxial anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden Medical University		Leiden	South Holland	2333ZA	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided