Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)
Completed
Conditions studied: Critically Illness, Sedation, Invasive Mechanical Ventilation, Acute Respiratory Distress Syndrome
In brief
The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation. The authors therefore designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to: 1. assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective), 2. investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective), 3. report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).
Key facts
- Study ID
- NCT04383730
- Run by
- University Hospital, Clermont-Ferrand
- People needed
- 203
- Starts
- 2020-06-26
- Expected to finish
- 2021-04-30
- Last updated by the study team
- 2021-09-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients (18 years old),
- Admitted to a participating ICU (or any other ICU-like setting that may be deployed as a result of the COVID-19 pandemics, such as in the operating room, post-anesthesia care unit, step-down unit or any COVID-19-specific unit set in response to the pandemics in a participating center),
- Requiring invasive mechanical ventilation,
- With suspected or confirmed COVID-19 on day 0.
You may not qualify if…
- None
Where it is running
- Beth Israel Deaconess Medical Center, Inc. — Boston, Massachusetts, United States
- CHU — Brest, France
- CHU — Clermont-Ferrand, France
- Centre Hospitalier — Dunkirk, France
- Pitié-Salpêtrière Hospital - APHP — Paris, France
- CH Privé de la Loire — Saint-Etienne, France
- Universitätsklinikum — Bochum, Germany
- University Medical Center Schleswig-Holstein — Kiel, Germany
- Universitätsklinikum — Oldenburg, Germany
- Hospital Clínico Universitario de Valencia — Valencia, Spain
- Cantonal Hospital — Münsterlingen, Switzerland
- Universitätsspital — Zurich, Switzerland
Full record on ClinicalTrials.gov
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