Status:
RECRUITING
The ALOFT Pilot Trial
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
The Ottawa Hospital Academic Medical Association
Conditions:
Vascular Diseases
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The ALOFT Pilot Trial will evaluate three pragmatic elements (recruitment, adherence, and follow-up) of neuraxial versus general anesthesia for lower limb revascularization surgery that are necessary ...
Detailed Description
Background: Despite promising evidence suggesting benefit from neuraxial anesthesia for lower limb revascularization surgery, our data demonstrate that use of neuraxial anesthesia varies 6-fold betwee...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy, patch angioplasty
- Able to access a telephone for postoperative follow-up
Exclusion
- Absolute contraindications to neuraxial anesthesia: impaired coagulation state (due to intrinsic, congenital or extrinsic (i.e., anticoagulant not held for guideline recommended period based on the American Society of Regional Anesthesia recommendations) factors), infection at the needle insertion point, increased intracranial pressure or intracranial mass, uncorrected hypovolemia or hypotension (systolic blood pressure \<90 mmHg), severe uncorrected aortic stenosis)
- Traumatic arterial injuries as an indication for surgery
- Multiple sclerosis or demyelinating central nervous system conditions
- Known malignant hyperthermia or who require a malignant hyperthermia trigger-free anesthetic
- Pregnancy
- Prior enrollment in this study, or participating in another interventional trial that could interfere with interpretation of data for either study (may be acceptable if unrelated interventions/outcomes and study PIs mutually agree in writing to co-enrollment)
- Determination by the surgeon, anesthesiologist, or other clinician, that the patient would not be suitable for randomization
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06067789
Start Date
March 25 2024
End Date
January 1 2027
Last Update
April 4 2024
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6