Abdominal Aortic AneurysmNCT06491589
Feasibility and Outcomes of Endovascular Aneurysm Repairs (EVARs) Without Arterial Line Monitoring
An observational study of Abdominal Aortic Aneurysm, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2024to 1 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients undergoing percutaneous EVAR at the QEII Health Sciences center.
Who may be able to join
- Adult patients undergoing percutaneous EVAR at the Queen Elizabeth II Health Sciences center from June 1st 2024 - May 31st 2025.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
Loukman Ghouti, 782-641-7795, LoukmanGhouti@dal.ca
About this study
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.
Read the 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. Historically, aortic aneurysm repair was primarily conducted through open aneurysm repair (OAR), involving a large abdominal incision to access the diseased segment of the aorta directly. Although effective, OAR was characterized by extensive surgical trauma, prolonged operative times, and significant physiological disturbances, often requiring intensive care stays with associated morbidity and mortality. In recent decades, the landscape has greatly shifted such that aortic aneurysm repair has now become a streamlined procedure, with some medical centers offering endovascular repair as day procedures, and allowing most patients to return home the following day.
Endovascular Aneurysm Repair (EVAR) has been pivotal in this transformation, providing minimally invasive alternatives to traditional open surgery. Unlike conventional approaches, EVAR involves repairing aneurysms without a large laparotomy incision and aortic clamping, using instead stent grafts delivered from within the vessel to reinforce weakened sections of the aorta. This method offers numerous advantages over conventional surgery, including reduced surgical trauma and shorter recovery times. Historically, EVARs required general anesthesia and bilateral femoral surgical exposure. However, recent innovations, such as percutaneously inserted lower-profile devices and the use of local anesthesia, have further simplified the procedure, mitigating the complexities associated with general anesthesia induction and maintenance.
Usually, following the patient's entry into the operating room for an EVAR procedure, they are provided with an arterial line. Arterial lines ('art' lines) allow continuous monitoring of blood pressure, providing beat-to-beat measurements. They also offer a convenient method for obtaining arterial blood samples, eliminating the need for multiple needle punctures. Despite their utility, arterial lines carry potential complications (incidence rate of 1% for both minor and major complications across radial, femoral, and axillary artery cannulations among adult patients), including infection, thrombosis, vasospasm, hematoma formation, and air embolism. Inserting an arterial line also extends the procedure time, contingent on factors such as patient anatomy and physician expertise. Patient perception of arterial lines may vary, with some finding the insertion uncomfortable, particularly during initial placement and securing.
At our institution, standard EVARs are preferentially performed with a "simplest practice possible" approach. This idea removes any unnecessary instrumentation of the patient, while still prioritizing patient safety. Our approach so far includes omitting urinary catheterization, employing a percutaneous approach and performing the surgery under local anesthesia. In an effort to advance our understanding and optimize patient care, our institution has explored the possibility of EVARs without arterial line monitoring. Through collaborative discussions involving surgical, anesthesia, and nursing teams, patients deemed candidates have undergone EVAR procedures without arterial monitoring. In cases where beat-to-beat monitoring was necessary intra-operatively, a transducer connected to the femoral arterial sheath was used to provide information equivalent to traditional arterial lines. Similarly, if an arterial blood sample was required, it was obtained directly from the arterial sheath.
This novel approach, though not yet described in literature, holds promise for improving procedural efficiency and patient outcomes. Omitting arterial lines could potentially streamline procedures, enhance patient satisfaction, and reduce complication risks associated with arterial access. Reforming standard-of-care paradigms, whether in clinic or operating room, is a well-established practice in medicine. A similarly innovative approach was undertaken by the Vancouver Heart Team for transcatheter aortic valve replacement (TAVR) procedures. They developed a standardized clinical pathway for safe early discharge after TAVR. Following implementation, retrospective analysis revealed that patients discharged early exhibited more favorable clinical indicators compared to those with standard discharge protocols. This study, one among many, illustrates how simplifying procedures and care standards, while maintaining patient safety, can achieve positive outcomes.
However, several critical questions remain unanswered, including the impact on operating time, complication rates, and acceptance by the treating teams. As such, this proposal seeks to address these uncertainties by investigating the feasibility and outcomes of EVARs without arterial line monitoring. By systematically evaluating this approach, we aim to optimize patient care pathways and enhance procedural efficiency.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal aortic aneurysm, EVAR, Arterial monitoring
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | EVAR with arterial line monitoring | |
| Group B | EVAR with no arterial line monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Assess technical feasibility of no art-line EVAR.
Technical feasibility (time required for pre-op prep and setup; duration of procedure)
Measured: 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.
Measured: 12 months
Secondary outcomes (1)
Assess complication rates of no art-line EVAR as compared to traditional EVAR procedures using arterial line monitoring.
Assess the overall complication rates (incidence) of the no art-line approach to EVAR.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loukman Ghouti, Nova Scotia Health Authority
- Investigators
- Loukman Ghouti, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491589
- Sponsor's protocol ID
- 1030377
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This discussion has not been broached yet.
Publications
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.
PubMed 32276013Jessula 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.
PubMed 38301848
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Outcomes of Endovascular Aneurysm Repairs (EVARs) Without Arterial Line Monitoring
- ClinicalTrials.gov ID
- NCT06491589
- Acronym / sponsor ID
- 1030377
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal aortic aneurysm, EVAR, Arterial monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Historically, aortic aneurysm repair was primarily conducted through open aneurysm repair (OAR), involving a large abdominal incision to access the diseased segment of the aorta directly. Although effective, OAR was characterized by extensive surgical trauma, prolonged operative times, and significant physiological disturbances, often requiring intensive care stays with associated morbidity and mortality. In recent decades, the landscape has greatly shifted such that aortic aneurysm repair has now become a streamlined procedure, with some medical centers offering endovascular repair as day procedures, and allowing most patients to return home the following day.
Endovascular Aneurysm Repair (EVAR) has been pivotal in this transformation, providing minimally invasive alternatives to traditional open surgery. Unlike conventional approaches, EVAR involves repairing aneurysms without a large laparotomy incision and aortic clamping, using instead stent grafts delivered from within the vessel to reinforce weakened sections of the aorta. This method offers numerous advantages over conventional surgery, including reduced surgical trauma and shorter recovery times. Historically, EVARs required general anesthesia and bilateral femoral surgical exposure. However, recent innovations, such as percutaneously inserted lower-profile devices and the use of local anesthesia, have further simplified the procedure, mitigating the complexities associated with general anesthesia induction and maintenance.
Usually, following the patient's entry into the operating room for an EVAR procedure, they are provided with an arterial line. Arterial lines ('art' lines) allow continuous monitoring of blood pressure, providing beat-to-beat measurements. They also offer a convenient method for obtaining arterial blood samples, eliminating the need for multiple needle punctures. Despite their utility, arterial lines carry potential complications (incidence rate of 1% for both minor and major complications across radial, femoral, and axillary artery cannulations among adult patients), including infection, thrombosis, vasospasm, hematoma formation, and air embolism. Inserting an arterial line also extends the procedure time, contingent on factors such as patient anatomy and physician expertise. Patient perception of arterial lines may vary, with some finding the insertion uncomfortable, particularly during initial placement and securing.
At our institution, standard EVARs are preferentially performed with a "simplest practice possible" approach. This idea removes any unnecessary instrumentation of the patient, while still prioritizing patient safety. Our approach so far includes omitting urinary catheterization, employing a percutaneous approach and performing the surgery under local anesthesia. In an effort to advance our understanding and optimize patient care, our institution has explored the possibility of EVARs without arterial line monitoring. Through collaborative discussions involving surgical, anesthesia, and nursing teams, patients deemed candidates have undergone EVAR procedures without arterial monitoring. In cases where beat-to-beat monitoring was necessary intra-operatively, a transducer connected to the femoral arterial sheath was used to provide information equivalent to traditional arterial lines. Similarly, if an arterial blood sample was required, it was obtained directly from the arterial sheath.
This novel approach, though not yet described in literature, holds promise for improving procedural efficiency and patient outcomes. Omitting arterial lines could potentially streamline procedures, enhance patient satisfaction, and reduce complication risks associated with arterial access. Reforming standard-of-care paradigms, whether in clinic or operating room, is a well-established practice in medicine. A similarly innovative approach was undertaken by the Vancouver Heart Team for transcatheter aortic valve replacement (TAVR) procedures. They developed a standardized clinical pathway for safe early discharge after TAVR. Following implementation, retrospective analysis revealed that patients discharged early exhibited more favorable clinical indicators compared to those with standard discharge protocols. This study, one among many, illustrates how simplifying procedures and care standards, while maintaining patient safety, can achieve positive outcomes.
However, several critical questions remain unanswered, including the impact on operating time, complication rates, and acceptance by the treating teams. As such, this proposal seeks to address these uncertainties by investigating the feasibility and outcomes of EVARs without arterial line monitoring. By systematically evaluating this approach, we aim to optimize patient care pathways and enhance procedural efficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –EVAR with arterial line monitoring |
| Group B | – | –EVAR with no arterial line monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients undergoing percutaneous EVAR at the QEII Health Sciences center.
Key inclusion criteria (1 listed)
- Adult patients undergoing percutaneous EVAR at the Queen Elizabeth II Health Sciences center from June 1st 2024 - May 31st 2025.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess acceptability of no art-line EVAR.
Time frame: 12 months
Acceptability (user satisfaction, perceived appropriateness, perceived positive or negative effects on organization) will be determined by a Likert scale survey circulated to treating staff.
Assess technical feasibility of no art-line EVAR.
Time frame: 12 months
Technical feasibility (time required for pre-op prep and setup; duration of procedure)
Asess safety of no art-line EVAR.
Time frame: 12 months
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.
1 secondary outcome
Assess complication rates of no art-line EVAR as compared to traditional EVAR procedures using arterial line monitoring.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 32276013Dunn 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.
- Background: PubMed 38301848Jessula 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.
- Individual participant dataSharing planned: Undecided. This discussion has not been broached yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loukman Ghouti principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loukman Ghouti (782-641-7795, LoukmanGhouti@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess acceptability of no art-line EVAR. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06491589, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.