Brief Title
Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA)
Official Title
Non-invasive Peri- and Postoperative Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm
Brief Summary
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
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
Primary Outcome
Pulse wave change from baseline during EVAR measured by a force sensor
Secondary Outcome
Pulse wave change from baseline after EVAR measured by a force sensor
Condition
Cardiovascular Diseases
Intervention
Noninvasive pulse wave analysis sensor, ECG-sensor
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
30
Start Date
April 8, 2018
Completion Date
August 30, 2021
Primary Completion Date
August 30, 2021
Eligibility Criteria
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
Gender
All
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
, 400591911, [email protected]
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT03493074
Organization ID
R17129
Responsible Party
Sponsor
Study Sponsor
Tampere University Hospital
Collaborators
Tampere University of Technology
Study Sponsor
, ,
Verification Date
October 2020