Vascular DiseasesNCT06067789
The ALOFT Pilot Trial
A study testing neuraxial anesthesia in people with Vascular Diseases and Peripheral Artery Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Peripheral Artery Disease, Surgery
- What is being tested?
- neuraxial anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Emily Hladkowicz, PhD, 613-798-5555 ext. 18629, emhladkowicz@toh.ca
About this study
Official title: Anesthesia for Lower Limb Revascularization to Optimize Functional ouTcomes
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.
Read the detailed description
Background: Despite promising evidence suggesting benefit from neuraxial anesthesia for lower limb revascularization surgery, our data demonstrate that use of neuraxial anesthesia varies 6-fold between Canadian hospitals and is decreasing over time. Currently available evidence is largely observational. Only data from a multicenter, randomized trial of anesthesia type for lower limb revascularization surgery, powered for patient-reported outcomes and designed with patient and knowledge user partners, will provide the high-certainty evidence of the possible benefits of neuraxial anesthesia. Therefore, we are designing the Anesthesia for Lower limb revascularization to Optimize Functional ouTcomes (ALOFT) Trial to address this important question. Prior to conducting this full trial, the feasibility of the trial protocol must be demonstrated using a multicenter pilot design.
Overarching Aim: 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.
Methods:
Design, setting and participants:
The ALOFT Pilot Trial is an assessor blinded, multicenter, individual patient, parallel-arm randomized controlled trial.
People => 18 years with a planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy, patch angioplasty will be included.
Intervention: The 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.
Outcomes and sample size: Primary outcome is monthly recruitment. Secondary outcomes are intervention adherence, retention, and elicitation of patient, clinician and researcher-identified barriers. Our pilot trial sample size estimate is informed by a power calculation for the future full-scale trial. In the future trial, a sample of 778 (389/arm) will provide 90% power using ANCOVA to detect the 5% minimally important between group difference in the continuous WHODAS score assuming a common standard deviation of 20 and a correlation with baseline of 0.4 (as observed in our previous work4) as well as accounting for up to 10% attrition and up to 10% cross-over. For the pilot trial, a sample size of 90 directly links to our 3 feasibility outcomes.
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: Our objective is for results of the planned full trial to change practice in caring for lower limb revascularization surgery patients.
- Conditions
- Vascular Diseases, Peripheral Artery Disease, Surgery
- Being tested
- neuraxial anesthesia
- Medical subject headings
- Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuraxial anesthesiaProcedure or surgery
Intervention arm participants will be allocated to neuraxial anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly recruitment
Monthly recruitment of >=2 participants per center means that the full trial should be feasible
Measured: 2 years
Secondary outcomes (3)
Intervention adherence
>=90% of participants were treated with allocated randomization arm to minimize the risk of contamination bias
Measured: 1 day
Retention
>=90% of participants at the patient-reported primary outcome point of 30-days after surgery should minimize attrition bias in the definitive trial's primary outcome data
Measured: 30 days
Elicitation of patient, clinician and researcher-identified barriers and facilitators
For study participants, at 30-day follow-up, a survey will be administered focusing on the acts of enrolling and being followed up in the trial. For research team members, a survey focused on the acts of participant recruitment and study support will be done once per site for all researchers, inclusive of clinician researchers and research staff, at approximately 3-4 months after study launch at their site.
Measured: 30 days, 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start25 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Ottawa Hospital Academic Medical Association, University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Daniel McIsaac, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067789
- Sponsor's protocol ID
- CTO-TBD
- Status last verified
- Apr 2024
- First submitted
- 14 Sep 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia for Lower Limb Revascularization to Optimize Functional ouTcomes
- ClinicalTrials.gov ID
- NCT06067789
- Acronym / sponsor ID
- CTO-TBD
- Conditions
- Vascular Diseases, Peripheral Artery Disease, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Ottawa Hospital Academic Medical Association, University of Ottawa
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Despite promising evidence suggesting benefit from neuraxial anesthesia for lower limb revascularization surgery, our data demonstrate that use of neuraxial anesthesia varies 6-fold between Canadian hospitals and is decreasing over time. Currently available evidence is largely observational. Only data from a multicenter, randomized trial of anesthesia type for lower limb revascularization surgery, powered for patient-reported outcomes and designed with patient and knowledge user partners, will provide the high-certainty evidence of the possible benefits of neuraxial anesthesia. Therefore, we are designing the Anesthesia for Lower limb revascularization to Optimize Functional ouTcomes (ALOFT) Trial to address this important question. Prior to conducting this full trial, the feasibility of the trial protocol must be demonstrated using a multicenter pilot design.
Overarching Aim: 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.
Methods:
Design, setting and participants:
The ALOFT Pilot Trial is an assessor blinded, multicenter, individual patient, parallel-arm randomized controlled trial.
People => 18 years with a planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy, patch angioplasty will be included.
Intervention: The 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.
Outcomes and sample size: Primary outcome is monthly recruitment. Secondary outcomes are intervention adherence, retention, and elicitation of patient, clinician and researcher-identified barriers. Our pilot trial sample size estimate is informed by a power calculation for the future full-scale trial. In the future trial, a sample of 778 (389/arm) will provide 90% power using ANCOVA to detect the 5% minimally important between group difference in the continuous WHODAS score assuming a common standard deviation of 20 and a correlation with baseline of 0.4 (as observed in our previous work4) as well as accounting for up to 10% attrition and up to 10% cross-over. For the pilot trial, a sample size of 90 directly links to our 3 feasibility outcomes.
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: Our objective is for results of the planned full trial to change practice in caring for lower limb revascularization surgery patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: neuraxial anesthesiaIntervention 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuraxial anesthesiaIntervention arm participants will be allocated to neuraxial anesthesia. | Procedure or surgery | Intervention |
Primary outcome
Monthly recruitment
Time frame: 2 years
Monthly recruitment of >=2 participants per center means that the full trial should be feasible
3 secondary outcomes
Intervention adherence
Time frame: 1 day
Retention
Time frame: 30 days
Elicitation of patient, clinician and researcher-identified barriers and facilitators
Time frame: 30 days, 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Yes. Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel McIsaac, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuraxial anesthesia in people with Vascular Diseases and Peripheral Artery Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Hladkowicz, PhD (c) (613-798-5555 ext. 18629, emhladkowicz@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly recruitment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.