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NCT03973320 Clinical Trial

Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty

Hypotension Clinical Trial

Official title:
Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03973320
Other study ID # 2018-2235
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 27, 2018
Est. completion date November 18, 2019

Study information
Verified date March 2024
Source Hospital for Special Surgery, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective chart review to determine if neuraxial anesthesia is associated with worse outcomes after Primary Total Hip Arthroplasty.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11292
Est. completion date November 18, 2019
Est. primary completion date November 18, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Chart Review
This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.

Locations
Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (1)
Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery
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