Clinical trial NCT06067789: The ALOFT Pilot Trial
Official title: Anesthesia for Lower Limb Revascularization to Optimize Functional ouTcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Diseases
Peripheral Artery Disease
Surgery
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Ottawa Hospital Academic Medical Association
name: University of Ottawa
First posted: 2023-10-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 between Canadian hospitals and is decreasing over time. Currently available evidence is largely observational. Only data from a multicenter, randomized trial of anesthesia type for lower limb revascularization surgery, powered for patient-reported outcomes and designed with patient and knowledge user partners, will provide the high-certainty evidence of the possible benefits of neuraxial anesthesia. Therefore, we are designing the Anesthesia for Lower limb revascularization to Optimize Functional ouTcomes (ALOFT) Trial to address this important question. Prior to conducting this full trial, the feasibility of the trial protocol must be demonstrated using a multicenter pilot design.

Overarching Aim: 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.

Methods:

Design, setting and participants:

The ALOFT Pilot Trial is an assessor blinded, multicenter, individual patient, parallel-arm randomized controlled trial.

People =\> 18 years with a planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy, patch angioplasty will be included.

Intervention: The 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.

Outcomes and sample size: Primary outcome is monthly recruitment. Secondary outcomes are intervention adherence, retention, and elicitation of patient, clinician and researcher-identified barriers. Our pilot trial sample size estimate is informed by a power calculation for the future full-scale trial. In the future trial, a sample of 778 (389/arm) will provide 90% power using ANCOVA to detect the 5% minimally important between group difference in the continuous WHODAS score assuming a common standard deviation of 20 and a correlation with baseline of 0.4 (as observed in our previous work4) as well as accounting for up to 10% attrition and up to 10% cross-over. For the pilot trial, a sample size of 90 directly links to our 3 feasibility outcomes.

Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.

Expected outcomes: Our objective is for results of the planned full trial to change practice in caring for lower limb revascularization surgery patients.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy, patch angioplasty
3. Able to access a telephone for postoperative follow-up

Exclusion Criteria:

1. 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)
2. Traumatic arterial injuries as an indication for surgery
3. Multiple sclerosis or demyelinating central nervous system conditions
4. Known malignant hyperthermia or who require a malignant hyperthermia trigger-free anesthetic
5. Pregnancy
6. 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)
7. Determination by the surgeon, anesthesiologist, or other clinician, that the patient would not be suitable for randomization

Primary outcomes:
measure: Monthly recruitment
timeFrame: 2 years
Secondary outcomes:
measure: Intervention adherence
timeFrame: 1 day
measure: Retention
timeFrame: 30 days
measure: Elicitation of patient, clinician and researcher-identified barriers and facilitators
timeFrame: 30 days, 120 days
Other outcomes:
measure: Rate of suspected spinal cord hematomas or infections
timeFrame: 1 year
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: 30 days, 90 days, 1 year
measure: EuroQol Health-related quality of life (EQ-5D-5L)
timeFrame: 30 days, 90 days, 1 year
measure: Pain Score
timeFrame: up to 3 days, 30 days, 90 days, 1 year
measure: Satisfaction with anesthesic technique: 'Likelihood to recommend', reflecting on a 10-point scale their likelihood to recommend their anesthetic technique to a future patient having the same surgery
timeFrame: up to 3 days
measure: Quality of Recovery Score: How well the patient feels they have recovered from their anesthetic and operation
timeFrame: up to 3 days
measure: Delirium
timeFrame: 1 month
measure: Complications
timeFrame: 1 month
measure: Index hospitalization
timeFrame: 1 month
measure: Major adverse limb events
timeFrame: 30 days, 90 days, 1 year
measure: Days at home
timeFrame: 30 days
measure: Readmission
timeFrame: up to 1 year
measure: Emergency department visits
timeFrame: up to 1 year
measure: Survival
timeFrame: up to 1 year
measure: Healthy system costs
timeFrame: up to 1 year
measure: Rate of spinal hematomas or infections
timeFrame: 1 year
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Daniel McIsaac, MD
role: PRINCIPAL_INVESTIGATOR
References: