Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study

Study Overview
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Brief Summary
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The diaphragm is the fundamental muscle of the respiratory system. The diaphragmatic dysfunction is present in 60% of critical patients at hospital admission and up to 80% after prolonged mechanical ventilation and difficult weaning. Risk factors associated with diaphragm dysfunction and atrophy are sepsis, trauma, sedatives, steroids, and muscle relaxants. The main pathology characteristics of diaphragm biopsies of mechanically ventilated patients are atrophy and a reduction in contractility, determining an impact on the clinical outcome. Shi et al. found a higher section area of the diaphragm muscle fiber in biopsies of post mortem COVID-19 patients versus negative patients, independently from days of mechanical ventilation. The hypothesis of our study is to identify different clusters of pathological presentation in post-mortem COVID-19 mechanically ventilated patients.

Official Title
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Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study.

Conditions
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Diaphragm Injury, Pathology, COVID-19 Acute Respiratory Distress Syndrome, Ventilation Therapy; Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients deceased in the intensive care unit positive to SARS-CoV-2 and mechanically ventilated post-mortem examination of the diaphragm Exclusion Criteria: patients with a terminal disease and a prognosis of less than 48 hours at admission.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical characteristics | Evaluate if there are specific clusters in the study population and find different clinical characteristics. | One week post mortem | 
| Blood test characteristics | Evaluate if there are specific clusters in the study population and find different blood test characteristics. | One week post mortem | 
| Pathology characteristics | Evaluate if there are specific clusters in the study population and find different pathology characteristics. | One week post mortem | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation | Verify if there are correlations between the clusters characteristics and the other variables in the study population mechanical ventilation. | One week post mortem | 
| Therapy | Verify if there are correlations between the clusters characteristics and therapy in the study population. | One week post mortem | 
| Arterial blood gas analysis | Verify if there are correlations between the clusters characteristics and arterial blood gas in the study population. | One week post mortem |