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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)

NCT04383730 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 203

Last updated 2021-09-05

No results posted yet for this study

Summary

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).

Conditions

  • Critically Illness
  • Sedation
  • Invasive Mechanical Ventilation
  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Intravenous sedation

Patients will be included retrospectively in the study by local investigators at each participating center. As this is a non-interventional study, sedation practices will be those currently used as standard practices in participating centers, including both intravenous and inhaled sedation practices

DRUG

Inhaled sedation

Patients will be included retrospectively in the study by local investigators at each participating center. As this is a non-interventional study, sedation practices will be those currently used as standard practices in participating centers, including both intravenous and inhaled sedation practices

Sponsors & Collaborators

  • Hospital Clínico Universitario de Valencia

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    collaborator OTHER

  • Groupe Hospitalier Pitie-Salpetriere

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Matthieu Jabaudon · University Hospital, Clermont-Ferrand

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • United States
  • France
  • Germany
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383730 on ClinicalTrials.gov