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Low recruitment ratio
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It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study.
Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours.
Patients will be randomized to one of the treatment groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEVOFLURANE Group | Experimental |
| |
| PROPOFOL Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | 25 patients sedated with Sevoflurane via inhalation, starting with 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50) |
| Measure | Description | Time Frame |
|---|---|---|
| PaO2/FiO2 | To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19 | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| TNFα | To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 | Day 2 |
| IL-1b | To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Cruces | Barakaldo | Bizkaia | 48903 | Spain | ||
| Hospital Universitario RamĂłn y Cajal |
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Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open study
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| Propofol | Drug | 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50) |
|
| Day 2 |
| IL-6 | To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 | Day 2 |
| IL-8 | To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 | Day 2 |
| Mortality | To evaluate the 30-day mortality. | Day 30 |
| Madrid |
| 28034 |
| Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital ClĂnico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| 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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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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