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Intervention for Peripheral Arterial Disease

N/A

Recruiting

Led By Daniel McIsaac, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will first look at how well they can recruit, get participants to follow instructions, and keep in touch with them for lower limb surgery. This will help them plan a bigger study in the future

Who is the study for?

The ALOFT Pilot Trial is for adults over 18 who are scheduled for lower limb revascularization surgery, like arterial bypass or angioplasty. Participants need to be able to use a phone for follow-up. It's not specified who can't join the trial.Check my eligibility

What is being tested?

This pilot study tests neuraxial anesthesia against general anesthesia in surgeries for Peripheral Arterial Disease. It aims to assess recruitment, adherence, and follow-up processes needed for a larger future trial on anesthesia effectiveness.See study design

What are the potential side effects?

While specific side effects aren't listed here, generally neuraxial anesthesia may cause low blood pressure, headache, backache or difficulty urinating; general anesthesia might lead to nausea, vomiting, sore throat and confusion post-surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Monthly recruitment

Secondary outcome measures

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

Intervention adherence

Retention

Other outcome measures

Complications

Days at home

Delirium

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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.

Group II: ControlActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Ottawa Hospital Academic Medical AssociationOTHER

22 Previous Clinical Trials

2,806 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,424 Total Patients Enrolled

2 Trials studying Peripheral Arterial Disease

2,948 Patients Enrolled for Peripheral Arterial Disease

University of OttawaOTHER

208 Previous Clinical Trials

267,066 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research actively seeking participants at the moment?

"Affirmative. According to clinicaltrials.gov, this investigation is in active pursuit of candidates. The trial was initially publicized on March 25th, 2024 and last revised on April 2nd, 2024. Enrollment seeks to enlist a total of 90 participants from a single designated site."

Answered by AI

What is the upper limit for the total number of participants who can enroll in this clinical trial?

"Indeed, clinicaltrials.gov details that this investigation is actively pursuing suitable candidates. The trial was initially published on March 25th, 2024 and last revised on April 2nd, 2024. Enrollment of 90 participants will be conducted at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The ALOFT Pilot Trial

2024. "The ALOFT Pilot Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067789.

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