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

Colon Carcinima Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628431
• Other study ID #: P14.173
• Status: Completed
• Start date: October 2015
• Est. completion date: January 1, 2017

Study information

• Verified date: September 2019
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• any elective surgery under general or neuraxial anesthesia

Exclusion Criteria:

• non elective procedures

Related Conditions & MeSH terms

• Colon Carcinima

Intervention

Device:
• Elfi tech monitor

Locations

Country	Name	City	State
Netherlands	Leiden Medical University	Leiden	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	bloodpressure will be compared using conventional techniques and elfitor	up to 1 day
Primary	Neuraxial block	neuraxial block will be compared using conventional techniques and elfitor	up to 1 day
Secondary	Cardiac output	during induction of anesthesia the effect of anesthetics or neuraxial blok on cardiac output will be recorded	up to 1 day