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Grant: Project Grant

Ottawa Hospital Research Institute

$202,725.00

The Anesthesia for Lower limb revascularization to Optimize Functional OuTcomes (ALOFT) Trial: a pilot multicenter randomized trial

FY 2021-22

Summary
More than 700,000 Canadians have blockages in leg blood vessels that can cause trouble walking, and painful sores on the ankles and feet. Blockages can also cause loss of the leg through amputation. Surgery is an important treatment for blocked blood vessels but has risks. One in 5 patients having surgery get a complication like heart, lung or kidney problems. These make it hard to recover from surgery and prevent people from gaining benefits from surgery. Having a major surgery means that patients need an anesthetic, either by being put completely to sleep (called general anesthesia) or having the nerves to the lower legs frozen through an injection in the low back (called spinal anesthesia). When we look across all patients having surgery on their leg blood vessels, our data tell us that having a spinal anesthetic may lead to fewer complications, faster recovery and a lower risk of dying. Even though spinal anesthesia looks good in giving patients better outcomes, most don't get spinal anesthesia. This may be because the data that support spinal anesthesia don't come from the right kind of study to figure out what treatments work best. To truly know if spinal anesthesia is better than general, we need to do a study where the type of anesthesia is decided by the flip of a coin, called a randomized trial. We also need to know if the type of anesthesia leads to better outcomes in ways that really matter to patients. Results from randomized trials like this can be used to better inform patients of their options and change doctors' practices to give patients better outcomes. Randomized trials need a big commitment from patients and doctors, and can be costly. To make sure that a randomized trial can be done in a way that respects patients' time and can be done efficiently, a mini version called a 'pilot' is first performed. We propose to do a pilot study to figure out if a big trial of anesthesia type for leg blood vessel surgery should be done in the future.
Program
Project Grant
Location
Ontario, Canada
Recipient Type
Other
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
461907
Name
McIsaac Daniel I
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Health Services and Policy Research
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
The Anesthesia for Lower limb revascularization to Optimize Functional OuTcomes (ALOFT) Trial: a pilot multicenter randomized trial
Programtype2
Operating Grants
Orgnameinp2
Ottawa Hospital Research Institute
Cihramount2
$202,725
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Anesthesia; Barriers And Facilitators; Function; Patient Reported Outcomes; Peripheral Vascular Disease; Pilot Trial; Randomized Trial
Abstract
More than 700,000 Canadians have blockages in leg blood vessels that can cause trouble walking, and painful sores on the ankles and feet. Blockages can also cause loss of the leg through amputation. Surgery is an important treatment for blocked blood vessels but has risks. One in 5 patients having surgery get a complication like heart, lung or kidney problems. These make it hard to recover from surgery and prevent people from gaining benefits from surgery. Having a major surgery means that patients need an anesthetic, either by being put completely to sleep (called general anesthesia) or having the nerves to the lower legs frozen through an injection in the low back (called spinal anesthesia). When we look across all patients having surgery on their leg blood vessels, our data tell us that having a spinal anesthetic may lead to fewer complications, faster recovery and a lower risk of dying. Even though spinal anesthesia looks good in giving patients better outcomes, most don't get spinal anesthesia. This may be because the data that support spinal anesthesia don't come from the right kind of study to figure out what treatments work best. To truly know if spinal anesthesia is better than general, we need to do a study where the type of anesthesia is decided by the flip of a coin, called a randomized trial. We also need to know if the type of anesthesia leads to better outcomes in ways that really matter to patients. Results from randomized trials like this can be used to better inform patients of their options and change doctors' practices to give patients better outcomes. Randomized trials need a big commitment from patients and doctors, and can be costly. To make sure that a randomized trial can be done in a way that respects patients' time and can be done efficiently, a mini version called a 'pilot' is first performed. We propose to do a pilot study to figure out if a big trial of anesthesia type for leg blood vessel surgery should be done in the future.
Competitiondate
202203
Approvedterm2
2 yrs 6 mths
Pinamesdelim
McIsaac, Daniel I; Jerath, Angela; Kidd, Gurlavine D; Roberts, Derek J; Saha, Tarit; Taljaard, Monica; Wijeysundera, Duminda N
Approvedterm
2 ans 6 mois
Cihrcontribution2
~ $202,725~ $0~
Ottawa Hospital Research Institute - $202,725 Grant (… | Canada Spends