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 | Completed

• 1 other identifier: ISCA Study
• Study Type: observational
• Target: 203
• Locations: 5 countries
• Sites: 12

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. 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. 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. 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

Keywords

Mechanical ventilation; Acute Respiratory Distress Syndrome; Inhaled sedation; Intravenous sedation; Covid-19

Outcome Measures

Primary Outcomes (1)

• Number of days off the ventilator (VFD28, for ventilator-free days), taking into account death as a competing event

  Ventilator-free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after intubation, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. A period of assisted breathing lasting less than 24 hours and for the purpose of a surgical procedure will not count against the VFD calculation. If a patient was receiving assisted breathing at day 27 or died prior to day 28, VFDs will be zero. Patients transferred to another hospital or other health care facility will be followed to day 28 to assess this endpoint.

  Day 28 after inclusion

Secondary Outcomes (21)

• All-cause mortality

  Days 7, 14, and 28 after inclusion

• Ventilator-free days

  Days 7 and 14 after inclusion

• ICU-free days

  Day 28 after inclusion

• Duration of invasive mechanical ventilation

  Day 28 after inclusion

• Duration of controlled mechanical ventilation

  Day 28 after inclusion

Study Arms (2)

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

Drug: Intravenous sedation

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.

Drug: Inhaled sedation

Interventions

Intravenous sedation 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 intravenous sedation

Inhaled sedation 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted in ICUrequiring invasive mechanical ventilation and suspected or confirmed COVID19

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Hospital Clínico Universitario de Valencia: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Groupe Hospitalier Pitie-Salpetriere: collaborator

Study Sites (12)

Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, 02215, United States

Location

CHU

Brest, France

Location

CHU

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier

Dunkirk, France

Location

Pitié-Salpêtrière Hospital - APHP

Paris, 75013, France

Location

CH Privé de la Loire

Saint-Etienne, France

Location

Universitätsklinikum

Bochum, Germany

Location

University Medical Center Schleswig-Holstein

Kiel, Germany

Location

Universitätsklinikum

Oldenburg, Germany

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Cantonal Hospital

Münsterlingen, Switzerland

Location

Universitätsspital

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33857185 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Matthieu Jabaudon

  University Hospital, Clermont-Ferrand

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: June 26, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

FR (5); CH (2); DE (3); ES (1); US (1)