Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491589
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-20
Brief Title:
Feasibility and Outcomes of Endovascular Aneurysm Repairs EVARs Without Arterial Line Monitoring
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
Feasibility and Outcomes of Endovascular Aneurysm Repairs EVARs Without Arterial Line Monitoring
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None