Anesthesia Technique in COVID-19 Positive Hip Fracture Patients

January 5, 2023 updated by: Janny Ke, University of British Columbia

Association of Anesthesia Technique With Morbidity and Mortality in Patients With COVID-19 and Surgery for Hip Fracture: a Retrospective Population Cohort Study

Patients with COVID undergoing hip fracture repair have high mortality rates. If spinal anesthesia is associated with decreased rates of mortality, this study could provide hypothesis generating data for prospective studies. Investigators hypothesize that spinal anesthesia (SA) is associated with decreased mortality compared to general anesthesia (GA) for patients undergoing hip fracture surgery. The primary objective is to determine for patients undergoing hip surgery with COVID-19 infection, whether SA, as compared to GA, is associated with a lower rate of mortality 30 days postoperatively. The secondary objective is to determine whether SA, as compared to GA, is associated with a lower rate of morbidity 30 days postoperatively. Investigators will be analyzing a data set provided by the National Surgical Quality Improvement Program (NSQIP). Descriptive statistics will be performed. Multivariable logistic regression will be performed for the primary and secondary objectives.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Patients with hip fracture have poor outcomes, attributed to risk factors that include advanced age and higher rates of underlying chronic comorbidities. COVID-19 infection is an independent risk factor for increased mortality in hip fracture patients in the perioperative period. A recent meta-analysis demonstrates COVID-19 infection is associated with higher than seven-fold increase in risk of mortality. Recommended management of hip fracture includes timely surgical repair, multimodal pain control, and multidisciplinary follow-up, to facilitate return to mobility and independent function.

Anesthesia for hip fracture surgery can be achieved by either general anesthesia (GA) or spinal anesthesia (SA). The potential advantages of SA include opioid-sparing effects, lessened impacts on the respiratory and gastrointestinal systems, and reduction in rates of adverse outcomes such as pneumonia, mechanical ventilation, intensive care unit (ICU) admission, venous thromboembolism (VTE), myocardial infarction (MI), stroke, transfusion, readmission, and prolonged postoperative length of stay. However, a recent randomized control trial found no difference between SA and GA for older adults undergoing hip fracture surgery for the primary outcome of survival and recovery of ambulation at 60 days.

While emerging evidence shows COVID-19 infection increases mortality after hip surgery, there is a lack of research examining whether the choice of anesthetic technique modifies the postoperative mortality and morbidity of hip fracture patients with COVID-19 infection. This is particularly important due to the high mortality (35% in COVID-positive patients, vs. 2% in patients without COVID), with the potential for SA to modify this risk by circumventing the need for airway interventions. SA may also offer superiority over general anesthesia for limiting aerosol generation and exposure of operating room staff during the pandemic. While SA may reduce the risk of pulmonary morbidity by reducing the need for airway interventions, its motor block on accessory muscles and the need for sedation may adversely impact ventilation. Investigators hypothesize that spinal anesthesia (SA) is associated with decreased mortality compared to general anesthesia (GA) for patients undergoing hip fracture surgery.

Study Design: The requirement for written informed consent will be waived for use of deidentified data. Patient information will be obtained for the retrospective cohort analysis using the NSQIP® (general dataset linked with the Hip Fracture Procedure Targeted Dataset), a prospectively-collected multicentre dataset with more than 150 clinical variables within 30 days after surgery. The setting of this study will be patient data obtained from the multicentre generated NSQIP Hip Fracture Procedure Targeted Dataset. The period of patient data obtained will include from January 2017 through December 2021. We will omit the data from January 2020 to December 2020 given there was no reporting of COVID status during this period. Data will only be obtained from patients undergoing hip surgery with mortality and morbidity gathered for 30 days postoperatively. In this study, the investigators goal is to evaluate the adjusted association between anesthesia technique and mortality and morbidity after hip fracture surgery for patients who tested positive for COVID-19.

The primary objective is to determine for patients undergoing hip surgery with COVID-19 infection, whether SA, as compared to GA, is associated with a lower rate of mortality 30 days postoperatively.

Our secondary objective is to determine whether SA, as compared to GA, is associated with a lower rate of morbidity 30 days postoperatively. To provide context for interpretation, we will describe the epidemiology of the following rates during versus before the 2020 COVID-19 pandemic (January to December 2021, compared to 2017 to 2019): 1) SA versus GA uti-lization for hip fracture surgery, and 2) mortality and morbidity for hip surgery patients without COVID-19 infection. Finally, we will quantify the mortality and morbidity for pa-tients with versus without COVID-19 infection undergoing hip fracture surgery, stratified by SA and GA.

Purpose: The purpose of this study is to evaluate the adjusted association between anesthesia technique and mortality and morbidity after hip fracture surgery

Population cohorts: The study will be divided into three cohorts: those undergoing hip surgery 1) without COVID-19 infection January to December 2021, 2) with COVID-19 infection January to December 2021, and 3) pre-pandemic from January 2017 to December 2019.

Due to the variable duration of asymptomatic period that can precede symptoms and diagnosis, COVID-19 infection status will be classified as follows.

In the primary analysis, COVID-negative patients will be defined as no preoperative COVID (within 14 days before surgery) and no postoperative COVID, and COVID-positive patients will be defined as yes (lab-confirmed) preoperative COVID and no postoperative COVID. In NSQIP, preoperative COVID status denotes within 14 days be-fore surgery, and patients with preoperative COVID are always coded "No" for postopera-tive COVID. NSQIP does not have previous history of COVID prior to 14 days, which is a major limitation given the increased mortality of patients with recent COVID undergoing surgery (24).

In NSQIP, preoperative COVID status denotes within 14 days before surgery, and patients with preoperative COVID are always coded "No" for postoperative COVID. NSQIP does not have previous history of COVID prior to 14 days, which is a major limitation given the increased mortality of patients with recent COVID undergoing surgery.

As patients with postoperative COVID-positive status are difficult to interpret due to variable incubation period and the possibility of COVID-19 contraction while in hospital postoperatively, investigators will perform sensitivity analysis using alternative definitions for the COVID-positive cohort, including 1) laboratory confirmed preoperatively or postoperatively, 2) laboratory confirmed or symptomatic preoperatively, and 3) suspected and laboratory confirmed anytime preoperatively or postoperatively).

Data analysis: Investigators will be analyzing a data set provided by the National Surgical Quality Improvement Program (NSQIP). Descriptive statistics will be performed. Multivariable logistic regression will be performed for the primary and secondary objectives.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will include all patients 19 years or older who are sampled in the NSQIP Hip Fracture Procedure Targeted Dataset from January 2017 through December 2019 and January 2021 to December 2021 undergoing surgical fixation of hip fractures using either general and/or spinal anesthesia.

Description

Inclusion Criteria:

  • Sampled in the NSQIP Hip Fracture Procedure Targeted Dataset from January 2017 through December 2019 and from January 2021 to December 2021.
  • undergoing surgical fixation of hip fractures using either general and/or spinal anesthesia.
  • In case of reduced Procedure-Targeted data collection during the COVID-19 pandemic, investigators will also create a total open hip fracture cohort using relevant Current Procedural Terminology codes (27244, 27245, 27269, 27236, or 27248)

Exclusion Criteria:

  • Primary or secondary anesthetic technique listed as local anesthesia alone, local anesthesia with intravenous sedation, epidural, and those with no reported anesthesia technique
  • American Society of Anesthesiologists (ASA) Physical Status (PS) V (defined as "5-Moribund"), and
  • Ventilator-dependence preoperatively.
  • Platelet counts less than 80,000/mm3 within 90 days before surgery,
  • International normalized ratio (INR) greater than or equal to 1.5, or
  • Partial thromboplastin time (PTT) greater than 35 seconds (likelihood of being ineligible for SA)

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hip Surgery without COVID-19 infection
January to December 2021
Procedure: Hip Fracture Surgery
Hip fracture surgery
Hip Surgery with COVID-19 infection
January to December 2021
Procedure: Hip Fracture Surgery
Hip fracture surgery
Other: COVID-19 infection
COVID-19 infection
Hip Surgery pre-pandemic
January 2017 to December 2019
Procedure: Hip Fracture Surgery
Hip fracture surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 30 days post operatively
All-cause 30-day mortality following hip fracture surgery.
30 days post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke or cerebrovascular accident (CVA)
Time Frame: Within 30 days post operatively
Occurrence of a stroke or cerebrovascular accident (CVA) within 30 days following hip fracture surgery (Yes, or No).
Within 30 days post operatively
Myocardial Infarction (MI)
Time Frame: Within 30 days post operatively
Occurrence of a Myocardial Infarction intraoperatively or within 30 days following hip fracture surgery
Within 30 days post operatively
Postoperative Delirium
Time Frame: Within 30 days post operatively
Occurrence of postoperative delirium within 30 days following hip fracture surgery (Yes, or No).
Within 30 days post operatively
Pneumonia
Time Frame: Within 30 days post operatively
Occurrence of pneumonia within 30 days following hip fracture surgery (Yes, or No).
Within 30 days post operatively
Acute Renal Failure
Time Frame: Within 30 days post operatively
Occurrence of acute renal failure up to 30 days following hip fracture surgery (Yes, or No).
Within 30 days post operatively
Transfusion
Time Frame: Within 30 days post operatively
Participant had bleeding requiring a transfusion within 30 days following hip fracture surgery (Yes, or No).
Within 30 days post operatively
Post-Operative Ventilation
Time Frame: Within 30 days post operatively
Participant having a total cumulative duration of ventilator-assisted respirations greater than 48 hours during the postoperative hospitalization or any other time within 30 days following hip fracture surgery (Yes, or No).
Within 30 days post operatively
Hospital Readmission
Time Frame: Within 30 days post operatively
Participant readmitted to hospital within 30 days following hip fracture surgery (Yes, or No).
Within 30 days post operatively
Unplanned Reoperation
Time Frame: Within 30 days post operatively
Occurrence of an unplanned reoperation within 30 days following hip fracture surgery (Yes, or No).
Within 30 days post operatively
Length of Stay
Time Frame: Post-operative period in hospital, on average 5 days
Total number of days from the day of operation to the day of discharge from hospital
Post-operative period in hospital, on average 5 days
Hospital Stay greater than 30 days
Time Frame: Greater than 30 days postoperatively
If the participant has not yet been discharged from the acute care setting within 30 days after the primary procedure (Yes, or No).
Greater than 30 days postoperatively
Discharge Destination
Time Frame: Postoperative Period at Time of discharge, on average 5 days
Destination after discharge from hospital (home or not home)
Postoperative Period at Time of discharge, on average 5 days
Venous Thromboembolism
Time Frame: Within 30 days post operatively
Composite outcome of the occurrence of a pulmonary embolism or deep venous thrombosis within 30 days following hip fracture surgery.
Within 30 days post operatively
Sepsis
Time Frame: Within 30 days post operatively
Composite outcome of the occurrence of sepsis or septic shock within 30 days following hip fracture surgery.
Within 30 days post operatively
Any Complication or Death
Time Frame: Within 30 days post operatively
Composite outcome of the occurrence of any complication or participant deceased up to 30 days following hip fracture surgery.
Within 30 days post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Janny Xue Chen Ke, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 5, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 3, 2023

Study Registration Dates

First Submitted

November 21, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22-03212

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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