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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04383730
Other study ID # ISCA Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 26, 2020
Est. completion date April 30, 2021

Study information

Verified date August 2021
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
France CHU Brest
France CHU Clermont-Ferrand
France Centre Hospitalier Dunkerque
France Pitié-Salpêtrière Hospital - APHP Paris
France CH Privé de la Loire Saint-Étienne
Germany Universitätsklinikum Bochum
Germany University Medical Center Schleswig-Holstein Kiel
Germany Universitätsklinikum Oldenburg
Spain Hospital Clínico Universitario de Valencia Valencia
Switzerland Cantonal Hospital Münsterlingen
Switzerland Universitätsspital Zürich
United States Beth Israel Deaconess Medical Center, Inc. Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Groupe Hospitalier Pitie-Salpetriere, Hospital Clínico Universitario de Valencia, University Hospital Schleswig-Holstein

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 All-cause mortality All-cause mortality Days 7, 14, and 28 after inclusion
Secondary Ventilator-free days Ventilator-free days to days 7 and 14 are defined as the number of days from the time of initiating unassisted breathing to day 7 and 14 after intubation, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to days 7 and 14 If a patient returns to assisted breathing and subsequently achieves unassisted breathing to days 7 and 14 , VFDs will be counted from the end of the last period of assisted breathing to days 7 and 14. 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 6 or 13 or died prior to days 7 and 14, respectively,VFDs to days 7 and 14 will be zero. Patients transferred to another hospital or other health care facility will be followed to days 7 and 14 to assess this endpoint. Days 7 and 14 after inclusion
Secondary ICU-free days Number of days alive and not in the ICU from inclusion to day 28 Day 28 after inclusion
Secondary Duration of invasive mechanical ventilation Total duration of controlled mechanical ventilation to day 28 Day 28 after inclusion
Secondary Duration of controlled mechanical ventilation Total duration of controlled mechanical ventilation to day 28 Day 28 after inclusion
Secondary Physiological measures of lung function Arterial hypoxemia, as assessed by the partial pressure of arterial oxygen-to-fraction of inspired oxygen ratio (PaO2/FiO2) Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Secondary Physiological measures of lung function Partial pressure of arterial carbon dioxide (PaCO2) Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Secondary Physiological measures of lung function Inspiratory plateau pressure Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Secondary Physiological measures of lung function Driving pressure Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Secondary Physiological measures of lung function Mode of mechanical ventilation (assisted versus controlled) Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Secondary Physiological measures of lung function If available, 100 ms occlusion pressure (P0.1), a marker of respiratory drive Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
Secondary Development of complications Development of pneumothorax Day 7 from inclusion
Secondary Development of complications Supraventricular tachycardia Day 7 from inclusion
Secondary Development of complications New onset atrial fibrillation Day 7 from inclusion
Secondary Duration of vasopressor use Total duration (in days) of vasopressor use Day 28 after inclusion
Secondary Duration of renal replacement therapy Total duration (in days)of renal replacement therapy Day 28 after inclusion
Secondary Duration (in days) of any adjuvant therapies Adjuvant therapies are defined as: prone position, recruitment maneuvers, inhaled nitric oxide, inhaled epoprostenol sodium, high frequency ventilation, ECMO, neuromuscular blockade Day 7 from inclusion
Secondary Duration of continuous neuromuscular blockade Number of days with continuous neuromuscular blockade Day 28 from inclusion
Secondary Type of sedation practices Sedation drug(s) used (name(s)) Day 28 from inclusion
Secondary Duration of sedation practices Number of days with sedation Day 28 from inclusion
Secondary Modalities of sedation practices If inhaled sedation, device used to deliver it Day 28 from inclusion
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