Acute Respiratory Distress Syndrome Clinical Trial
— ISCAOfficial title:
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 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 |
Verified date | August 2021 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Groupe Hospitalier Pitie-Salpetriere, Hospital Clínico Universitario de Valencia, University Hospital Schleswig-Holstein |
United States, France, Germany, Spain, Switzerland,
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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