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

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

• Registration Number: NCT05191433
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-03-31
• Status Verified: 2022-01
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Study Completion: 2022-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood test characteristics	One week post mortem	Evaluate if there are specific clusters in the study population and find different blood test characteristics.
Pathology characteristics	One week post mortem	Evaluate if there are specific clusters in the study population and find different pathology characteristics.
Clinical characteristics	One week post mortem	Evaluate if there are specific clusters in the study population and find different clinical characteristics.

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation	One week post mortem	Verify if there are correlations between the clusters characteristics and the other variables in the study population mechanical ventilation.
Arterial blood gas analysis	One week post mortem	Verify if there are correlations between the clusters characteristics and arterial blood gas in the study population.
Therapy	One week post mortem	Verify if there are correlations between the clusters characteristics and therapy in the study population.

Trial Locations

Locations (2)

Azienda ospedaliero universitaria Friuli Centrale, Clinica di Anestesia e Rianimazione; 🇮🇹 Udine, Italy

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD; 🇮🇹 Udine, Italy