Database, Hypotension, Primary Total Hip Arthroplasty, Total Hip Arthroplasty
Conditions
Brief summary
This is a retrospective chart review to determine if neuraxial anesthesia is associated with worse outcomes after Primary Total Hip Arthroplasty.
Detailed description
The goal of this study is to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty. The plan to analyze the outcomes is listed below: Primary outcomes: Multiple logistic regression will be used to compute the adjusted odds ratios of any postoperative complications (MI, CVA, death) , adjusting for covariates including duration of intraoperative mean arterial pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure. Sensitivity analyses will also consider the effects of intra-operative hypotension (IOH) defined as mean blood pressure of less than 40, 45, 50, 55, 60, and 65 mm Hg. Secondary outcomes: Multiple logistic regression will be to compute the adjusted odds ratios of individual postoperative complications, (such as MI, CVA, stroke) , adjusting for covariates including duration of intraoperative mean blood pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure. Sensitivity analyses will also be conducted to test the effects of extend of IOH on complications.
Interventions
OTHERChart Review
This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.
Sponsors
Hospital for Special Surgery, New York
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* All primary total hip arthroplasty patient data with sufficiently complete intraoperative vital signs
Exclusion criteria
* Revision primary total hip arthroplasty * Incomplete intraoperative vital signs * Anterior total hip arthroplasty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality | Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery | The association between levels and length of intraoperative controlled hypotension and incidence rates of individual and composite outcome of any of the following events: (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death. If any of these events are positive, then the composite outcome will be positive. The units of measurement will be the same. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Total Hip Arthroplasty Without Complications This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty
Chart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients. | 11,224 |
| Primary Total Hip Arthroplasty With Common Complications This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty
Chart Review: This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients. | 68 |
| Total | 11,292 |
Baseline characteristics
| Characteristic | Primary Total Hip Arthroplasty With Common Complications | Total | Primary Total Hip Arthroplasty Without Complications |
|---|---|---|---|
| Age, Continuous | 75.6 years | 64 years | 64 years |
| Anesthetic type: Epidural/CSE | 52 Participants | 7692 Participants | 7640 Participants |
| Anesthetic type: Spinal | 16 Participants | 3600 Participants | 3584 Participants |
| ASA of 1 & 2 | 37 Participants | 9291 Participants | 9254 Participants |
| ASA of 3 | 31 Participants | 2001 Participants | 1970 Participants |
| BMI (Body Mass Index) | 28 kg/m^2 | 28.1 kg/m^2 | 28.1 kg/m^2 |
| Race/Ethnicity, Customized Race: White | 49 Participants | 9891 Participants | 9842 Participants |
| Sex: Female, Male Female | 30 Participants | 5985 Participants | 5955 Participants |
| Sex: Female, Male Male | 38 Participants | 5307 Participants | 5269 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 11,292 |
| other Total, other adverse events | 18 / 11,292 |
| serious Total, serious adverse events | 0 / 11,292 |
Outcome results
Primary
Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality
The association between levels and length of intraoperative controlled hypotension and incidence rates of individual and composite outcome of any of the following events: (i) myocardial infarction (MI), (ii) cerebrovascular accident (CVA), (iii) death. If any of these events are positive, then the composite outcome will be positive. The units of measurement will be the same.
Time frame: Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery
Population: 21 patients out of 11,292 fit complication definition.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Total Hip Arthroplasty | Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality | Myocardial Infarction | 16 Participants |
| Primary Total Hip Arthroplasty | Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality | Stroke | 2 Participants |
| Primary Total Hip Arthroplasty | Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality | In-Hospital mortality | 0 Participants |
| Primary Total Hip Arthroplasty | Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality | 30-day mortality | 3 Participants |