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

September 13, 2019 updated by: Albert Dahan, Leiden University Medical Center

The Application of the ELFI-TECH Monitor for Measurement of Blood Pressure, Cardiac Output and Extend of Regional and Neuraxial Anesthesia: The Elfitor Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Leiden, Zuid Holland, Netherlands, 2333ZA
        • Leiden Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • any elective surgery under general or neuraxial anesthesia

Exclusion Criteria:

  • non elective procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anesthesia
Patients that will recieve general anesthesia for elective surgery
Device: Elfi tech monitor
Other Names:
  • Elfitor
Regional or neuraxial anesthesia
Patients that will revieve regional or neuraxial anesthesia for elective surgery
Device: Elfi tech monitor
Other Names:
  • Elfitor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 6, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • P14.173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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