The ALOFT Pilot Trial

NCT06067789 | Recruiting DMC

• 1 other identifier: CTO-TBD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Monthly recruitment

  Monthly recruitment of \>=2 participants per center means that the full trial should be feasible

  2 years

Secondary Outcomes (3)

• Intervention adherence

  1 day

• Retention

  30 days

• Elicitation of patient, clinician and researcher-identified barriers and facilitators

  30 days, 120 days

Other Outcomes (16)

• Rate of suspected spinal cord hematomas or infections

  1 year

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

  30 days, 90 days, 1 year

• EuroQol Health-related quality of life (EQ-5D-5L)

  30 days, 90 days, 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Procedure: neuraxial anesthesia

Control

NO INTERVENTION

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 PROCEDURE

Intervention arm participants will be allocated to neuraxial anesthesia.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Ottawa Hospital Academic Medical Association: collaborator
• University of Ottawa: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• Daniel McIsaac, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Hladkowicz, PhD (c)

CONTACT

613-798-5555; emhladkowicz@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group allocation will not be indicated in data analyzed by the outcome assessors.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 5, 2023
• Study Start: March 25, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.

Locations

CA (1)