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Anesthesia for Lower Limb Revascularization to Optimize Functional ouTcomes

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 to support a successful, large-scale evaluation. We will concurrently use implementation science methodology to further refine processes for the larger trial. The future full ALOFT trial will be designed to evaluate the comparative effectiveness of two different anesthesia types for improving outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Contact Information
Primary
Emily Hladkowicz, PhD (c)
emhladkowicz@toh.ca
613-798-5555
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 90
Treatments
Experimental: Intervention
Intervention arm participants will be allocated to neuraxial anesthesia. The specific approach (spinal, epidural, or combined spinal and epidural) will be at the discretion of the treating anesthesiologist, as the underlying physiologic mechanisms and impacts are similar for both approaches. Allowing clinician discretion will reflect routine standard of care practice and support generalizability. Specific choice of neuraxial anesthetic medications, doses, and adjuncts will also be at the discretion of the attending anesthesiologist, supporting pragmatism. While existing randomized data do not suggest that the sedation level during neuraxial anesthesia leads to differences in outcomes, providers will be requested to maintain sedation at or below a 3 on the Observer's Assessment of Alertness/Sedation scale (OAAS; mild to moderate sedation consistent to responding to verbal stimuli), the same approach used in a recent large pragmatic trial of anesthesia in hip fracture patients.
No_intervention: Control
Control group participants will be allocated to general anesthesia. Choice of anesthetic medications and doses will be at the discretion of each anesthesiologist as per routine standard of care, again supporting conduct of a pragmatic and generalizable trial. Similarly, choice of airway management strategies and anesthetic depth will also be based on patient and provider preference, as a recent large randomized trial demonstrates that anesthetic depth is not causally linked to risk of morbidity or mortality after surgery. Details of general anesthesia management and medications will be collected for all patients.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), University of Ottawa, The Ottawa Hospital Academic Medical Association
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov

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