Regional Anesthesia, Vascular Grafting, Vascular Patency Clinical Trial
Official title:
Association of Anesthesia Technique With Graft Patency Rates After Open Lower Limb Revascularization: a Retrospective Population Cohort Study
| NCT number | NCT04730310 |
| Other study ID # | H20-03437 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 1, 2021 |
| Est. completion date | March 31, 2022 |
| Verified date | January 2023 |
| Source | University of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The role of regional anesthesia in lower extremity revascularization procedures on reducing graft failure and need for reoperation remains unclear. In this study, we will analyze data from the multicenter National Surgical Quality Improvement Program (ACS NSQIP®) to assess the association between regional anesthesia (RA) and graft outcomes, as compared to general anesthesia (GA). Our primary objective is to determine for patients undergoing elective open lower limb revascularization, whether RA (spinal, epidural, and peripheral nerve block), compared to GA or general anesthesia with regional anesthesia (GA+RA), is associated with higher rates of patent graft within 30 days postoperatively (primary outcome).
| Status | Completed |
| Enrollment | 8893 |
| Est. completion date | March 31, 2022 |
| Est. primary completion date | February 28, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 110 Years |
| Eligibility | Inclusion Criteria: - All elective cases within the NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019 will be included. - Hybrid procedures (where patients had both open and endovascular repair) are included, as long as there is an open component. Exclusion Criteria: - Patients will be excluded if they underwent urgent or emergency surgery (identified using NSQIP variable EMERGNCY=1 OR ELECTSURG=0) - local was the only anesthetic technique listed in principal and additional anesthesia technique. - missing data on exposure, procedure name, or status of elective surgery. This includes having "other" or "unknown" for BOTH principal and additional anesthesia technique - Patients with INR >= 1.5 on day of surgery |
| Country | Name | City | State |
|---|---|---|---|
| Canada | St. Paul's Hospital | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia |
Canada,
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* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Confounders | age, bleeding diathesis, severe COPD, total operating, time, renal failure, functional status, cardiac valvular disease, diabetes | day of surgery | |
| Other | Confounders | INR, PTT | day of surgery | |
| Primary | Graft Patency | Derived using NSQIP variables "Most Severe Procedural Outcome" LEO_MOSTSEVOUTCOME and "Untreated Loss of Patency" (i.e. not patent and no procedure done) LEO_ULP
Yes if LEO_MOSTSEVOUTCOME is any of Clinically Patent Graft Patent graft, no stenosis Patent graft with stenosis No if LEO_MOSTSEVOUTCOME is any of Death Image-proven graft thrombosis or clinically evident thrombosis with no planned intervention Major Amputation New bypass in the treated arterial segment Not documented Other Revised graft with stenosis Revised graft, no current stenosis No if LEO_ULP = "yes" |
30 days | |
| Secondary | Major reintervention | 1. Major reintervention, using NSQIP variable "Major Reintervention on the Bypass" defined as ""Yes" if the patient underwent a subsequent procedure (new or revision lower extremity bypass operation, jump/interposition graft revision, bypass graft thrombectomy/thrombolysis) within 30 days of the original primary operation." | 30 days | |
| Secondary | Amputation | 2. Amputation, using NSQIP variable "Major Amputation (Transtibial or Proximal)", defined as ""Yes" if the patient underwent transtibial or more proximal amputation on the ipsilateral leg within 30 days of the original primary operation." | 30 days | |
| Secondary | Bleeding requiring transfusion | 30 days | ||
| Secondary | Venous thromboembolism | 30 days | ||
| Secondary | MI or stroke | 30 days | ||
| Secondary | Pneumonia | 30 days | ||
| Secondary | length of postoperative hospital stay | 30 days | ||
| Secondary | Discharge destination | dichotomize as home vs. not home | 30 days | |
| Secondary | Readmission rate | 30 days | ||
| Secondary | death | 30 days or in-hospital admission | ||
| Secondary | Composite thromboembolism | combination of venothromboembolism, MI, stroke | 30 days | |
| Secondary | Composite Morbidity and Mortality | combination of bleeding requiring transfusion, venothromboembolism, MI, stroke, pneumonia, death | 30 days |