AzTrials
AzTrials

Hip FracturesNCT05133648

Anesthesia Technique in COVID-19 Positive Hip Fracture Patients

An observational study of Hip Fractures and COVID-19, run by University of British Columbia at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Hip Fractures, COVID-19, General Anesthesia
What is being tested?
Hip Fracture Surgery and COVID-19 infection
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
1 siteCanada
Study dates
5 Jan 2023to 3 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Hip Fracture Surgery, COVID-19 infection
Medical subject headings
Hip Fractures, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hip Fracture SurgeryProcedure or surgery

    Hip fracture surgery

  • COVID-19 infectionOther

    COVID-19 infection

Study groups in NCT05133648
Study groupRoleWhat they receive
Hip Surgery without COVID-19 infectionJanuary to December 2021
Receives: Procedure: Hip Fracture Surgery
Hip Surgery with COVID-19 infectionJanuary to December 2021
Receives: Procedure: Hip Fracture Surgery; Other: COVID-19 infection
Hip Surgery pre-pandemicJanuary 2017 to December 2019
Receives: Procedure: Hip Fracture Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

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

    Measured: 30 days post operatively

Secondary outcomes (15)
  1. Stroke or cerebrovascular accident (CVA)

    Occurrence of a stroke or cerebrovascular accident (CVA) within 30 days following hip fracture surgery (Yes, or No).

    Measured: Within 30 days post operatively

  2. Myocardial Infarction (MI)

    Occurrence of a Myocardial Infarction intraoperatively or within 30 days following hip fracture surgery

    Measured: Within 30 days post operatively

  3. Postoperative Delirium

    Occurrence of postoperative delirium within 30 days following hip fracture surgery (Yes, or No).

    Measured: Within 30 days post operatively

  4. Pneumonia

    Occurrence of pneumonia within 30 days following hip fracture surgery (Yes, or No).

    Measured: Within 30 days post operatively

  5. Acute Renal Failure

    Occurrence of acute renal failure up to 30 days following hip fracture surgery (Yes, or No).

    Measured: Within 30 days post operatively

  6. Transfusion

    Participant had bleeding requiring a transfusion within 30 days following hip fracture surgery (Yes, or No).

    Measured: Within 30 days post operatively

  7. Post-Operative Ventilation

    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).

    Measured: Within 30 days post operatively

  8. Hospital Readmission

    Participant readmitted to hospital within 30 days following hip fracture surgery (Yes, or No).

    Measured: Within 30 days post operatively

  9. Unplanned Reoperation

    Occurrence of an unplanned reoperation within 30 days following hip fracture surgery (Yes, or No).

    Measured: Within 30 days post operatively

  10. Length of Stay

    Total number of days from the day of operation to the day of discharge from hospital

    Measured: Post-operative period in hospital, on average 5 days

  11. Hospital Stay greater than 30 days

    If the participant has not yet been discharged from the acute care setting within 30 days after the primary procedure (Yes, or No).

    Measured: Greater than 30 days postoperatively

  12. Discharge Destination

    Destination after discharge from hospital (home or not home)

    Measured: Postoperative Period at Time of discharge, on average 5 days

  13. Venous Thromboembolism

    Composite outcome of the occurrence of a pulmonary embolism or deep venous thrombosis within 30 days following hip fracture surgery.

    Measured: Within 30 days post operatively

  14. Sepsis

    Composite outcome of the occurrence of sepsis or septic shock within 30 days following hip fracture surgery.

    Measured: Within 30 days post operatively

  15. Any Complication or Death

    Composite outcome of the occurrence of any complication or participant deceased up to 30 days following hip fracture surgery.

    Measured: Within 30 days post operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start5 Jan 2023
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion3 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05133648
Sponsor's protocol ID
H22-03212
Status last verified
Jan 2023
First submitted
21 Nov 2021
Last updated
9 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hu F, Jiang C, Shen J, Tang P, Wang Y. Preoperative predictors for mortality following hip fracture surgery: a systematic review and meta-analysis. Injury. 2012 Jun;43(6):676-85. doi: 10.1016/j.injury.2011.05.017. Epub 2011 Jun 17.

    PubMed 21683355
  • Panula J, Pihlajamaki H, Mattila VM, Jaatinen P, Vahlberg T, Aarnio P, Kivela SL. Mortality and cause of death in hip fracture patients aged 65 or older: a population-based study. BMC Musculoskelet Disord. 2011 May 20;12:105. doi: 10.1186/1471-2474-12-105.

    PubMed 21599967
  • Sheikh HQ, Hossain FS, Aqil A, Akinbamijo B, Mushtaq V, Kapoor H. A Comprehensive Analysis of the Causes and Predictors of 30-Day Mortality Following Hip Fracture Surgery. Clin Orthop Surg. 2017 Mar;9(1):10-18. doi: 10.4055/cios.2017.9.1.10. Epub 2017 Feb 13.

    PubMed 28261422
  • De C, Harbham PK, Postoyalko C, Bhavanasi B, Paringe V, Theivendran K. Mortality Following Hip Fracture Surgery During COVID-19 Pandemic Compared to Pre-COVID-19 Period: A Case Matched Cohort Series. Malays Orthop J. 2021 Jul;15(2):107-114. doi: 10.5704/MOJ.2107.016.

    PubMed 34429830
  • Fell A, Malik-Tabassum K, Rickman S, Arealis G. Thirty-day mortality and reliability of Nottingham Hip Fracture Score in patients with COVID19 infection. J Orthop. 2021 Jul-Aug;26:111-114. doi: 10.1016/j.jor.2021.07.009. Epub 2021 Jul 16.

    PubMed 34305350
  • Zamora T, Sandoval F, Demandes H, Serrano J, Gonzalez J, Lira MJ, Klaber I, Carmona M, Botello E, Schweitzer D. Hip Fractures in the Elderly During the COVID-19 Pandemic: A Latin-American Perspective With a Minimum 90-Day Follow-Up. Geriatr Orthop Surg Rehabil. 2021 Jul 9;12:21514593211024509. doi: 10.1177/21514593211024509. eCollection 2021.

    PubMed 34290897
  • Cuthbert R, Ferguson D, Kayani B, Haque S, Ali A, Parkar A, Bates P, Vemulapalli K. Evidence-based approach to providing informed consent for hip fracture surgery during the COVID-19 era. World J Orthop. 2021 Jun 18;12(6):386-394. doi: 10.5312/wjo.v12.i6.386. eCollection 2021 Jun 18.

    PubMed 34189076
  • Kumar A, Haider Y, Passey J, Khan R, Gaba S, Kumar M. Mortality Predictors in Covid-19 Positive Patients with Fractures: A Systematic Review. Bull Emerg Trauma. 2021 Apr;9(2):51-59. doi: 10.30476/BEAT.2021.87742.

    PubMed 34150914
  • Grassi A, Andriolo L, Golinelli D, Tedesco D, Rosa S, Gramegna P, Ciaffi J, Meliconi R, Landini MP, Filardo G, Fantini MP, Zaffagnini S. Higher 90-Day Mortality after Surgery for Hip Fractures in Patients with COVID-19: A Case-Control Study from a Single Center in Italy. Int J Environ Res Public Health. 2021 May 13;18(10):5205. doi: 10.3390/ijerph18105205.

    PubMed 34068405
  • Balakumar B, Nandra RS, Woffenden H, Atkin B, Mahmood A, Cooper G, Cooper J, Hindle P. Mortality risk of surgically managing orthopaedic trauma during the COVID-19 pandemic. Bone Jt Open. 2021 May;2(5):330-336. doi: 10.1302/2633-1462.25.BJO-2020-0189.R1.

    PubMed 34027674
  • Alcock H, Moppett EA, Moppett IK. Early mortality outcomes of patients with fragility hip fracture and concurrent SARS-CoV-2 infection : a systematic review and meta-analysis. Bone Jt Open. 2021 May;2(5):314-322. doi: 10.1302/2633-1462.25.BJO-2020-0183.R1.

    PubMed 34003031
  • Lim MA, Pranata R. Coronavirus disease 2019 (COVID-19) markedly increased mortality in patients with hip fracture - A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 Jan;12(1):187-193. doi: 10.1016/j.jcot.2020.09.015. Epub 2020 Sep 17.

    PubMed 32958988
  • Mittal R, Banerjee S. Proximal femoral fractures: Principles of management and review of literature. J Clin Orthop Trauma. 2012 Jun;3(1):15-23. doi: 10.1016/j.jcot.2012.04.001. Epub 2012 Jun 16.

    PubMed 25983451
  • Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.

    PubMed 33289066
  • Jakobsson J, Johnson MZ. Perioperative regional anaesthesia and postoperative longer-term outcomes. F1000Res. 2016 Oct 11;5:F1000 Faculty Rev-2501. doi: 10.12688/f1000research.9100.1. eCollection 2016.

    PubMed 27785357

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fractures and COVID-19, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 30 days post operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05133648, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in