- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544775
Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Shoulder Surgery
May 31, 2018 updated by: Ottawa Hospital Research Institute
Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Ambulatory Shoulder Surgery
This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ontario.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
First, investigators will validate health administrative data codes to demonstrate the accuracy of Ontario-wide anesthesia type and regional anesthesia interventions using a reference standard (Ottawa Hospital Data Warehouse data).
Then, these validated exposures, in combination with validated outcome measures, will be used to examine the impact of anesthesia interventions on patient and health system outcomes for ambulatory shoulder surgery.
Study Type
Observational
Enrollment (Actual)
15000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This will be a retrospective, population-based, cohort study based in Ontario, Canada.
Our study population will include all Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery.
The study period extends from April 2009 to March 2016.
Description
Inclusion Criteria:
- Ontario residents
- Aged 18 years and older
- Elective ambulatory shoulder surgery performed in Ontario between April 2009 and December 2016.
Exclusion Criteria:
- Emergency Surgery
- If a patient undergoes multiple elective shoulder surgeries within the time period, only the first surgery will be included for any participant in the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Isolated General Anesthesia
Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have not had a nerve block identified using physician billing codes.
|
No nerve block identified through physician billing codes
Other Names:
|
Peripheral Nerve Block
Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery in Ontario and have a nerve block identified using physician billing codes.
|
Nerve block identified through physician billing codes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative death, admission, readmission or emergency department visits
Time Frame: Date of surgery to 7 days after surgery or death date, whichever came first
|
Composite outcome of: 1) unplanned admissions on the day of surgery , 2) post-discharge emergency department visits within 7 days of surgery, 3) readmission within 7 days of surgery, and 4) death from any cause
|
Date of surgery to 7 days after surgery or death date, whichever came first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health system costs
Time Frame: Date of surgery to 7 days after surgery or death date, whichever came first
|
Costs will be calculated using standardized patient-level costing algorithms.
|
Date of surgery to 7 days after surgery or death date, whichever came first
|
Neurology consultations or diagnostics
Time Frame: Date of surgery to 90 days after surgery or death date, whichever came first
|
Occurrence of neurology consult and/or nerve conduction study
|
Date of surgery to 90 days after surgery or death date, whichever came first
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel McIsaac, MD, MPH, Department of Anesthesiology and Pain Medicine, University of Ottawa, Ontario, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2009
Primary Completion (Actual)
March 31, 2016
Study Completion (Actual)
March 31, 2018
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
May 31, 2018
First Posted (Actual)
June 4, 2018
Study Record Updates
Last Update Posted (Actual)
June 4, 2018
Last Update Submitted That Met QC Criteria
May 31, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMH2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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