Status:
NOT_YET_RECRUITING
Feasibility and Outcomes of Endovascular Aneurysm Repairs (EVARs) Without Arterial Line Monitoring
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
Brief Summary
Endovascular Aortic Aneurysm Repairs (EVARs) are typically performed with arterial line monitoring, however our institution has successfully omitted this practice in select cases without complications...
Detailed Description
The management of aortic aneurysms has undergone a remarkable transformation in recent years, moving from traditional open surgical approaches to minimally invasive endovascular techniques. Historical...
Eligibility Criteria
Inclusion
- Adult patients undergoing percutaneous EVAR at the Queen Elizabeth II Health Sciences center from June 1st 2024 - May 31st 2025.
Exclusion
- Patients requiring surgical femoral exposure.
- Patients requiring fenestrated endografts: these are more complex cases, take a longer duration, usually require a general anesthetic and are at higher risk of arterial rupture, and thus cannot safely be performed without an arterial line.
- Patients undergoing EVAR with an Endologix endograft: there is a small risk of anaphylaxis with the polymer used with the Endologix endograft, and thus the arterial line is required for beat-to-beat monitoring during graft deployment.
- Patients with heavily calcified iliac or femoral arteries: this increases the risk of arterial rupture, and thus requires beat-to-beat arterial monitoring.
- Absence of significant co-morbidities: no severe aortic stenosis (AS) (suspected AS and echo diagnostic criteria: max jet velocity \>4.0 m/s, mean gradient \>40 mmHg, valve area \<1 cm²); No congestive heart failure (CHF) (CHF diagnostic criteria: ejection fraction (EF) below 50% and natriuretic (NT) pro-Brain Natriuretic Peptide (BNP) levels based on the following age-adjusted cutoff limits.
- Age \< 50 years: NT pro-BNP greater than 450 ng/L.
- Age 50-75 years: NT pro-BNP greater than 900 ng/L.
- Age \> 75 years: NT pro-BNP greater than 1800 ng/L.); Blood pressure below 180/120 on the morning of the operation day; Surgeon and/or anesthesiologist discretion.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06491589
Start Date
August 1 2024
End Date
December 1 2025
Last Update
July 9 2024
Active Locations (1)
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1
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7