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)

NCT ID: NCT04383730

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 203 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-26
• Study Completion Date: 2021-04-30

Brief 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).

Detailed Description

The acute respiratory distress syndrome (ARDS) is the most severe and lethal complication of COVID-19, and healthcare resource utilizations are currently being heavily challenged in most countries worldwide, with a high risk that some intensive care resources, such as the number of ventilators to allow management all patients, may be insufficient to face the current surge in ARDS cases. There is, therefore, an urgent need to evaluate candidate therapies that may impact clinical outcomes in patients with COVID-19-related ARDS and potentially be relevant to current public health issues, in accordance with the international efforts by the World Health Organization (WHO) (Global research on coronavirus disease) and most international public health organizations. Beyond the current efforts to find specific antiviral therapies or vaccines, improving supportive care and treatment options for patients with COVID-19-related ARDS, in accordance with up-to-date guidelines on the management of critically ill patients with COVID-19 (Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019; The Australian and New Zealand Intensive Care Society (ANZICS) COVID-19 Guidelines; Recommandations d'experts SRLF-SFAR-SFMU-GFRUP-SPILF sur la prise en charge en réanimation des patients en période d'épidémie à SARS-CoV2), is of major importance.

Indeed, given the number of intensive care unit (ICU) patients for whom the question of sedation applies during the current COVID-19 outbreak, any sedation practice that would be associated with improved clinical outcomes could have significant economic and public health implications. In this perspective, the rationale supporting inhaled sedation with halogenated agents (such as isoflurane or sevoflurane) as a way to improve lung function, to decrease the inflammatory response, and to possibly improve patient outcome is strong.

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).

This study will be performed in accordance with the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) statement.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Usual practice of intravenous sedation

The choice of the intravenous sedative agent, including the type of and dosing of the agent, will be as per the treating clinicians at each center

Intravenous sedation

Intervention Type: DRUG

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

Usual practice of inhaled sedation

The choice of the inhaled sedative agent, including the type of and dosing of the agent, will be as per the treating clinicians at each center.

Inhaled sedation

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clínico Universitario de Valencia

OTHER

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu Jabaudon

Role: STUDY_CHAIR

University Hospital, Clermont-Ferrand

Locations

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

Countries

United States; France; Germany; Spain; Switzerland

References

Blondonnet R, Quinson A, Lambert C, Audard J, Godet T, Zhai R, Pereira B, Futier E, Bazin JE, Constantin JM, Jabaudon M. Use of volatile agents for sedation in the intensive care unit: A national survey in France. PLoS One. 2021 Apr 15;16(4):e0249889. doi: 10.1371/journal.pone.0249889. eCollection 2021.

Reference Type: DERIVED

PMID: 33857185 (View on PubMed)

Other Identifiers

ISCA Study

Identifier Type: -

Identifier Source: org_study_id