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| Name | Class |
|---|---|
| Hospital Clínico Universitario de Valencia | OTHER |
| University Hospital Schleswig-Holstein | OTHER |
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
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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:
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 :
This study will be performed in accordance with the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) statement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality | Days 7, 14, and 28 after inclusion |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted in ICUrequiring invasive mechanical ventilation and suspected or confirmed COVID19
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| Name | Affiliation | Role |
|---|---|---|
| Matthieu Jabaudon | University Hospital, Clermont-Ferrand | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center, Inc. | Boston | Massachusetts | 02215 | United States | ||
| CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33857185 | Derived | 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. |
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|
| 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 |
|
| Days 7 and 14 after inclusion |
| ICU-free days | Number of days alive and not in the ICU from inclusion to day 28 | Day 28 after inclusion |
| Duration of invasive mechanical ventilation | Total duration of controlled mechanical ventilation to day 28 | Day 28 after inclusion |
| Duration of controlled mechanical ventilation | Total duration of controlled mechanical ventilation to day 28 | Day 28 after inclusion |
| 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 |
| Physiological measures of lung function | Partial pressure of arterial carbon dioxide (PaCO2) | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion |
| Physiological measures of lung function | Inspiratory plateau pressure | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion |
| Physiological measures of lung function | Driving pressure | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion |
| Physiological measures of lung function | Mode of mechanical ventilation (assisted versus controlled) | Days 1, 2, 3, 4, 5, 6, and 7 from inclusion |
| 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 |
| Development of complications | Development of pneumothorax | Day 7 from inclusion |
| Development of complications | Supraventricular tachycardia | Day 7 from inclusion |
| Development of complications | New onset atrial fibrillation | Day 7 from inclusion |
| Duration of vasopressor use | Total duration (in days) of vasopressor use | Day 28 after inclusion |
| Duration of renal replacement therapy | Total duration (in days)of renal replacement therapy | Day 28 after inclusion |
| 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 |
| Duration of continuous neuromuscular blockade | Number of days with continuous neuromuscular blockade | Day 28 from inclusion |
| Type of sedation practices | Sedation drug(s) used (name(s)) | Day 28 from inclusion |
| Duration of sedation practices | Number of days with sedation | Day 28 from inclusion |
| Modalities of sedation practices | If inhaled sedation, device used to deliver it | Day 28 from inclusion |
| Brest |
| France |
| CHU | Clermont-Ferrand | 63000 | France |
| Centre Hospitalier | Dunkirk | France |
| Pitié-Salpêtrière Hospital - APHP | Paris | 75013 | 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 |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
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