Feasibility and Outcomes of Endovascular Aneurysm Repairs (EVARs) Without Arterial Line Monitoring

NCT06491589 | Not Yet Recruiting

• 1 other identifier: 1030377
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 or patient safety concerns. To investigate this further, our planned study will compare patients undergoing EVAR with and without arterial line monitoring. Data will be collected on pre-operative characteristics (patient age, sex, comorbidities), intraoperative details (procedural time, need for emergent intra-operative arterial monitoring or blood draws), and postoperative outcomes (complications, time in post-operative recovery unit). Operating room staff satisfaction and acceptability will be measured using a survey developed by our team. The findings from this study hold promise for improvement the treatment of aortic aneurysms, as well as enhancing patient safety and experience.

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal aortic aneurysm; EVAR; Arterial monitoring

Outcome Measures

Primary Outcomes (3)

• Assess acceptability of no art-line EVAR.

  Acceptability (user satisfaction, perceived appropriateness, perceived positive or negative effects on organization) will be determined by a Likert scale survey circulated to treating staff.

  12 months

• Assess technical feasibility of no art-line EVAR.

  Technical feasibility (time required for pre-op prep and setup; duration of procedure)

  12 months

• Asess safety of no art-line EVAR.

  Although this has already been established to be a safe and viable surgical technique, it would still be interesting to collect data on the incidence of intra-op and post-op complications.

  12 months

Secondary Outcomes (1)

• Assess complication rates of no art-line EVAR as compared to traditional EVAR procedures using arterial line monitoring.

  12 months

Study Arms (2)

Group A

EVAR with arterial line monitoring

Group B

EVAR with no arterial line monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing percutaneous EVAR at the QEII Health Sciences center.

You may qualify if:

• Adult patients undergoing percutaneous EVAR at the Queen Elizabeth II Health Sciences center from June 1st 2024 - May 31st 2025.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (2)

• Dunn K, Jessula S, Herman CR, Smith M, Lee MS, Casey P. Safety and effectiveness of single ProGlide vascular access in patients undergoing endovascular aneurysm repair. J Vasc Surg. 2020 Dec;72(6):1946-1951. doi: 10.1016/j.jvs.2020.03.028. Epub 2020 Apr 8.

  PMID: 32276013 BACKGROUND

• Jessula S, Cote C, Khoury M, DeCarlo C, Bellomo TR, Grant-Gorveatt A, Herman C, Smith M, Dua A, Eagleton M, Casey P, Zacharias N. Local Anesthesia for Endovascular Repair of Abdominal Aortic Aneurysm Allows for Accurate Graft Deployment with Durable Results. Ann Vasc Surg. 2024 May;102:64-73. doi: 10.1016/j.avsg.2023.11.033. Epub 2024 Jan 30.

  PMID: 38301848 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Loukman Ghouti

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loukman Ghouti

CONTACT

782-641-7795; LoukmanGhouti@dal.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 9, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CA (1)