- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04383730
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) (ISCA)
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:
- 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),
- 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),
- report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).
Study Overview
Status
Conditions
Intervention / Treatment
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 :
- 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),
- 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),
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brest, France
- CHU
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Clermont-Ferrand, France, 63000
- CHU
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Dunkerque, France
- Centre Hospitalier
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Paris, France, 75013
- Pitié-Salpêtrière Hospital - APHP
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Saint-Étienne, France
- CH Privé de la Loire
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Bochum, Germany
- Universitätsklinikum
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Kiel, Germany
- University Medical Center Schleswig-Holstein
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Oldenburg, Germany
- Universitätsklinikum
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Valencia, Spain
- Hospital Clinico Universitario de Valencia
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Münsterlingen, Switzerland
- Cantonal Hospital
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Zürich, Switzerland
- Universitätsspital
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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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
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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.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days off the ventilator (VFD28, for ventilator-free days), taking into account death as a competing event
Time Frame: Day 28 after inclusion
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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.
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Day 28 after inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: Days 7, 14, and 28 after inclusion
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All-cause mortality
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Days 7, 14, and 28 after inclusion
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Ventilator-free days
Time Frame: Days 7 and 14 after inclusion
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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.
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Days 7 and 14 after inclusion
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ICU-free days
Time Frame: Day 28 after inclusion
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Number of days alive and not in the ICU from inclusion to day 28
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Day 28 after inclusion
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Duration of invasive mechanical ventilation
Time Frame: Day 28 after inclusion
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Total duration of controlled mechanical ventilation to day 28
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Day 28 after inclusion
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Duration of controlled mechanical ventilation
Time Frame: Day 28 after inclusion
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Total duration of controlled mechanical ventilation to day 28
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Day 28 after inclusion
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Physiological measures of lung function
Time Frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Arterial hypoxemia, as assessed by the partial pressure of arterial oxygen-to-fraction of inspired oxygen ratio (PaO2/FiO2)
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Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Physiological measures of lung function
Time Frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Partial pressure of arterial carbon dioxide (PaCO2)
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Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Physiological measures of lung function
Time Frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Inspiratory plateau pressure
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Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Physiological measures of lung function
Time Frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Driving pressure
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Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Physiological measures of lung function
Time Frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Mode of mechanical ventilation (assisted versus controlled)
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Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Physiological measures of lung function
Time Frame: Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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If available, 100 ms occlusion pressure (P0.1), a marker of respiratory drive
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Days 1, 2, 3, 4, 5, 6, and 7 from inclusion
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Development of complications
Time Frame: Day 7 from inclusion
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Development of pneumothorax
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Day 7 from inclusion
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Development of complications
Time Frame: Day 7 from inclusion
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Supraventricular tachycardia
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Day 7 from inclusion
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Development of complications
Time Frame: Day 7 from inclusion
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New onset atrial fibrillation
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Day 7 from inclusion
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Duration of vasopressor use
Time Frame: Day 28 after inclusion
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Total duration (in days) of vasopressor use
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Day 28 after inclusion
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Duration of renal replacement therapy
Time Frame: Day 28 after inclusion
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Total duration (in days)of renal replacement therapy
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Day 28 after inclusion
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Duration (in days) of any adjuvant therapies
Time Frame: Day 7 from inclusion
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Adjuvant therapies are defined as: prone position, recruitment maneuvers, inhaled nitric oxide, inhaled epoprostenol sodium, high frequency ventilation, ECMO, neuromuscular blockade
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Day 7 from inclusion
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Duration of continuous neuromuscular blockade
Time Frame: Day 28 from inclusion
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Number of days with continuous neuromuscular blockade
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Day 28 from inclusion
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Type of sedation practices
Time Frame: Day 28 from inclusion
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Sedation drug(s) used (name(s))
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Day 28 from inclusion
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Duration of sedation practices
Time Frame: Day 28 from inclusion
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Number of days with sedation
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Day 28 from inclusion
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Modalities of sedation practices
Time Frame: Day 28 from inclusion
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If inhaled sedation, device used to deliver it
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Day 28 from inclusion
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Syndrome
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID Numbers
- ISCA Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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