Anesthesia Technique in COVID-19 Positive Hip Fracture Patients

NCT05133648 | Unknown

• 1 other identifier: H22-03212
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures; COVID-19; General Anesthesia; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  All-cause 30-day mortality following hip fracture surgery.

  30 days post operatively

Secondary Outcomes (15)

• Stroke or cerebrovascular accident (CVA)

  Within 30 days post operatively

• Myocardial Infarction (MI)

  Within 30 days post operatively

• Postoperative Delirium

  Within 30 days post operatively

• Pneumonia

  Within 30 days post operatively

• Acute Renal Failure

  Within 30 days post operatively

Study Arms (3)

Hip Surgery without COVID-19 infection

January to December 2021

Procedure: Hip Fracture Surgery

Hip Surgery with COVID-19 infection

January to December 2021

Procedure: Hip Fracture Surgery; Other: COVID-19 infection

Hip Surgery pre-pandemic

January 2017 to December 2019

Procedure: Hip Fracture Surgery

Interventions

Hip Fracture Surgery PROCEDURE

Hip fracture surgery

Hip Surgery pre-pandemic; Hip Surgery with COVID-19 infection; Hip Surgery without COVID-19 infection

COVID-19 infection OTHER

COVID-19 infection

Hip Surgery with COVID-19 infection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (26)

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  PMID: 38129357 DERIVED

MeSH Terms

Conditions

Hip Fractures; COVID-19

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Janny Xue Chen Ke, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: November 24, 2021
• Study Start: January 5, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 3, 2023
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

CA (1)