Recruiting

ALOFT

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06067789

Conditions

Vascular Diseases

Peripheral Artery Disease

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

neuraxial anesthesia

Study Details

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.

Conditions

Vascular Diseases

Peripheral Artery Disease

Surgery

Study ID

NCT06067789

Start date

Mar 25, 2024

Status verified date

Apr, 2024

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

neuraxial anesthesia

Intervention arm participants will be allocated to neuraxial anesthesia.

Primary outcome measure

  • Monthly recruitment [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Emily Hladkowicz, PhD (c)

613-798-5555emhladkowicz@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 4, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-04-04.