The Impact of COVID-19 Pandemic on Critical Limb Threatening Ischemia and Emergency Vascular Practice

This is a retrospective analytical study conducted at Vascular and Endovascular surgery Department, Mansoura University Hospital, including all patients admitted at the two periods first six months of 2019 and 2020.To demonstrate the effect of COVID-19 pandemic on the practice of emergency vascular surgery and critical limb threatening ischemia interventions by comparison two periods first six months of 2019 and 2020.

Study Overview

• Status: Completed
• Conditions: COVID; Critical Limb Ischemia
• Intervention / Treatment: Other: COVID 19 impact

Detailed Description

INTRODUCTION:

The novel coronavirus pneumonia (COVID-19) pandemic has affected the globe, with Italy leading many reports of the incidence and mortalities. Recently reported studies have described the clinical characteristics and overall outcomes of patients with COVID-19 and the effects of treating these patients on the healthcare system.Two studies have reported associated coagulopathy disorders. These reports have highlighted the presence of a coexisting hypercoagulable state in patients with COVID-19, which might be associated with higher mortality.

The COVID-19 pandemic has had many impacts, both seen and unforeseen, all over the world. As expected, elective endovascular procedures have been halted, with a significant decrease in urgent/emergent procedures. This could reflect an understandable unwillingness on the part of patients who continue to self-isolate at home to come in for treatments, including those with Critical limb threatening ischemia. Also impacts on the supply chain side of performing interventions, had been reported, it is challenging to be in the middle of a complex CLTI (Critical limb threatening ischemia) case and request a routine device only to find out it is unavailable.

Aim of the work Evaluation the impact of COVID-19 pandemic on emergency vascular practice and critical limb ischemia.

Outcome

Primary outcomes:

• Frequencies of patients admitted at the Vascular.
• Predisposing Factors.
• Number of ICU admission.

Secondary outcomes:

• Mortality rates

Patients and methods Study location: The study will be conducted at the department of vascular surgery in Mansoura university hospitals Type of study: Observational analytical study Study duration: 2019-2020 Sample size: It will include all patients presented to our department at the first 6 months of 2019 and first 6 months of 2020. sample size will be 140-400 patients Inclusion criteria: all patients admitted to our department at that periods Exclusion criteria

1. Patients can't give consent (unconscious).
2. Those with mental or behavioral disorders will be excluded. Consent: Patients after signing informed consent that possible complication from the procedure ought to happen and what are the alternatives.

Data collection:

• All patients with complete medical records available will be documented
• Each patient's record will be analyzed to determine preexisting illnesses, admitting symptoms (including length of time to accessing medical care), admission physical findings, laboratory and results.
• Also, the type and duration of antibiotic therapy, the frequency and type of operative procedures performed and subsequent complications.
• Supporting modalities such as dialysis, blood product transfusion, and mechanical ventilation will be were reviewed.
• Each patient's premorbid medical profile, condition at admission, and subsequent treatment also will be analyzed to assess effect on mortality and development of complications.
• Standard treatment after admission including cardiovascular stabilization and assessment of extent of infection. Broad-spectrum antibiotics were administered to cover gram-positive cocci, gram-negative enteric rods, and anaerobic flora will be also reported.
• The procedure of Surgical Management will be described.

Statistical analysis

· The data will be analyzed using Statistical Package for the Social Sciences. The numerical outcomes e.g. age is calculated as median. Gender will be recorded as frequency and percentage. Chi Square test is applied to assess the association of various parameters. The results will be considered statistically significant if the p-value is found to be less than or equal to 0.05. To assess possible risk factors for mortality, univariate analyses will be completed initially to aid in determining the variables that should be included in a stepwise logistic regression model.

• Study Type: Observational
• Enrollment (Actual): 998

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35511
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

It will include all patients presented to our department at the first 6 months of 2019 and first 6 months of 2020.

Description

Inclusion Criteria:

• All patients admitted to our department at that periods.

Exclusion Criteria:

• Patients can't give consent (unconscious).
• Those with mental or behavioral disorders will be excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Era of COVID 19; Total number of cases admitted during first six months of 2020	Other: COVID 19 impact; The impact of COVID-19 pandemic on Critical limb threatening ischemia and emergency vascular practice
Era of Non COVID 19; Total number of cases admitted the first six months of 2019

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ICU admission with associated Pneumonia	The ICU admission caused by Pneumonia proved radio-logically at both periods	6 months
Impact of COVID-19 on the different presentation of vascular surgery at the emergency	percentage of different diagnoses at both periods	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rates	Mortality percentages at both periods	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): June 21, 2020
• Study Completion (Actual): June 21, 2020

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Emergencies; Ischemia
• Other Study ID Numbers: R.20.06.898 - 2020/06/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No