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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05191433
Enrollment
41
Registered
2022-01-13
Start date
2020-11-01
Completion date
2022-01-20
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical characteristicsOne week post mortemEvaluate if there are specific clusters in the study population and find different clinical characteristics.
Blood test characteristicsOne week post mortemEvaluate if there are specific clusters in the study population and find different blood test characteristics.
Pathology characteristicsOne week post mortemEvaluate if there are specific clusters in the study population and find different pathology characteristics.

Secondary

MeasureTime frameDescription
Mechanical ventilationOne week post mortemVerify if there are correlations between the clusters characteristics and the other variables in the study population mechanical ventilation.
TherapyOne week post mortemVerify if there are correlations between the clusters characteristics and therapy in the study population.
Arterial blood gas analysisOne week post mortemVerify if there are correlations between the clusters characteristics and arterial blood gas in the study population.

Countries

Italy

Contacts

Primary ContactLuigi Vetrugno, MD
luigi.vetrugno@asufc.sanita.fvg.it+ 39 0432559509

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026