Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA) (VBA)

Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm

This study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (AAA) and endovascular treatment of AAA (EVAR) on arterial pulse wave

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Abdominal Aortic Aneurysm
• Intervention / Treatment: Diagnostic test: Noninvasive pulse wave analysis sensor, ECG-sensor

Detailed Description

Abdominal aortic aneurysm (AAA) develops slowly and degeneratively (increasing diameter, wall tension, thinning and decreased wall strength, altered compliance) which affects the aortic pressure and wave reflection. In 50% of cases, AAA rupture may lead to death and 50% of the remaining patients referred to hospital die. This results in high costs and preventable loss of lives. AAA can also be detected by pulse wave (PW) analysis. which could enable development of easy to use, affordable and accurate methodology for the detection of AAAs. The measurement system used in the present study is capable of wireless recording of PWs from several different locations utilizing two different sensor modalities (blood-volume related photoplethysmographic (PPG) PWs and dynamic blood pressure PWs). The objective is to study PWs in the detection of AAA and the effects of endovascular repair (EVAR) and whether adverse effects (i.e. endograft failure) can be detected. It is hypothesized that AAA and failure of the operation can be detected by PW features, especially by printed flexible sensors which will improve the usability, patient comfort and safety (hygiene). The technology could make it possible to screen AAAs at lower costs even in the municipal health centers or by the patients themselves, at similar accuracy, without skilled personnel operating the diagnostic devices and therefore improve the cost effectiveness of AAA screening resulting in significant savings, resource reallocation in the healthcare and also improved patient safety and prevention of deaths. It could also enable patient-centered, comfort follow-up for patients treated by EVAR.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Niku Oksala, Professor; Phone Number: 400591911; Email: niku.oksala@professori.fi

Study Locations

• Finland
  • Tampere, Finland, FI-33014
    • Recruiting
    • Tampere university Hospital
    • Contact: Niku Oksala, Professor; Phone Number: +358 31164844; Email: niku.oksala@professori.fi
    • Principal Investigator: Niku KJ Oksala, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Finnish, Caucasian

Description

Inclusion Criteria:

• The patient has been clinically examined at policlinic of vascular surgery
• The patient has been examined with computed tomography (CT) imaging
• The patient has been considered a candidate for the EVAR of the AAA

Exclusion Criteria:

• A patient has a pacemaker
• A medical doctor decides that the measurement disturbs or risks the subject's treatment process
• Subject's denial (or withdrawal)
• A patient has at least one amputated limb
• The age of the test subject candidate is less than 18 years
• A test subject candidate is not able to understand the study or is not legally competent
• A test subject candidate has Ehlers-Danlos syndrome or Marfan syndrome

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave change from baseline during EVAR measured by a force sensor	A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave	2 hours
Pulse wave change from baseline during EVAR measured by a optical photoplethysmographic (PPG) sensor	Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave change from baseline after EVAR measured by a force sensor	A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave	30 days
Pulse wave change from baseline after EVAR measured by a optical photoplethysmographic (PPG) sensor	Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements	30 days
Pulse wave change from baseline after EVAR measured by a force sensor	A force sensor node for dynamic pressure-PW measurements is utilized to detect pulse wave	12 months
Pulse wave change from baseline after EVAR measured by a optical	Optical photoplethysmographic (PPG) sensor node is used for volume pulse measurements	12 months

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Tampere University; Tampere University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2018
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Aortic Diseases; Cardiovascular Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: R17129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No