COVID-19 Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study.
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.
| Status | Recruiting |
| Enrollment | 41 |
| Est. completion date | January 20, 2022 |
| Est. primary completion date | March 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD | Udine | |
| Italy | Azienda ospedaliero universitaria Friuli Centrale, Clinica di Anestesia e Rianimazione | Udine |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Sanitaria-Universitaria Integrata di Udine |
Italy,
Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15. Review. — View Citation
Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC. — View Citation
Hooijman PE, Beishuizen A, Witt CC, de Waard MC, Girbes AR, Spoelstra-de Man AM, Niessen HW, Manders E, van Hees HW, van den Brom CE, Silderhuis V, Lawlor MW, Labeit S, Stienen GJ, Hartemink KJ, Paul MA, Heunks LM, Ottenheijm CA. Diaphragm muscle fiber weakness and ubiquitin-proteasome activation in critically ill patients. Am J Respir Crit Care Med. 2015 May 15;191(10):1126-38. doi: 10.1164/rccm.201412-2214OC. — View Citation
McCool FD, Manzoor K, Minami T. Disorders of the Diaphragm. Clin Chest Med. 2018 Jun;39(2):345-360. doi: 10.1016/j.ccm.2018.01.012. Review. — View Citation
Shi Z, Bogaards SJP, Conijn S, Onderwater Y, Espinosa P, Bink DI, van den Berg M, van de Locht M, Bugiani M, van der Hoeven H, Boon RA, Heunks L, Ottenheijm CAC. COVID-19 is associated with distinct myopathic features in the diaphragm of critically ill patients. BMJ Open Respir Res. 2021 Sep;8(1). pii: e001052. doi: 10.1136/bmjresp-2021-001052. — View Citation
Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical characteristics | Evaluate if there are specific clusters in the study population and find different clinical characteristics. | One week post mortem | |
| Primary | Blood test characteristics | Evaluate if there are specific clusters in the study population and find different blood test characteristics. | One week post mortem | |
| Primary | Pathology characteristics | Evaluate if there are specific clusters in the study population and find different pathology characteristics. | One week post mortem | |
| Secondary | 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 | |
| Secondary | Therapy | Verify if there are correlations between the clusters characteristics and therapy in the study population. | One week post mortem | |
| Secondary | 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 |