Evaluating anesthesia types for lower limb surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ALOFT Pilot Trial aims to assess the feasibility of a larger trial comparing neuraxial and general anesthesia for lower limb revascularization surgery. It will focus on three key elements: recruitment, adherence, and follow-up, using implementation science methodologies to refine processes. The trial will involve participants aged 18 and older who are scheduled for specific surgical procedures. This pilot study will help establish the groundwork for a multicenter, randomized controlled trial to evaluate the effectiveness of anesthesia types in improving patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Daniel McIsaac, MD — The Ottawa Hospital
• Study coordinator: Emily Hladkowicz, PhD (c)
• Email: emhladkowicz@toh.ca
• Phone: 613-798-5555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.