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

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: Colon Carcinima
• Intervention / Treatment: Device: Elfi tech monitor

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center

Study record dates

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