The ALOFT Pilot Trial

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Sep 27, 2023

Keywords

ClinConnect Summary

The ALOFT Pilot Trial is a study designed to look at two types of anesthesia—neuraxial anesthesia (which numbs the lower body) and general anesthesia (which puts you to sleep)—for patients undergoing surgery to improve blood flow in the legs. This trial is important because it will help researchers understand how to better recruit participants, ensure they stick with the study, and follow up with them after surgery. The goal is to prepare for a larger trial that will compare the effectiveness of these two anesthesia types in helping patients recover and improve their health outcomes after surgery.

To be part of this study, you need to be at least 18 years old and scheduled for a specific type of leg surgery, such as a bypass or artery repair. You should also be able to use a phone for follow-up calls after your surgery. However, there are certain conditions that may exclude you, such as having issues with blood clotting or certain medical conditions like multiple sclerosis. If you join the trial, you can expect to have close follow-up and support from the research team, helping to ensure your safety and health during this important time.

Gender

ALL

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