| Trial registration number
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NCT04632043 |
Full text link
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04632043
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First author
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Ilias Siempos, MD, DSc
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Contact
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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isiempos@yahoo.com
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Registration date
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2020-11-17
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Recruitment status
Last imported at : Feb. 3, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
adult patients with confirmed covid-19 and severe acute hypoxemic respiratory failure
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Exclusion criteria
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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- postoperative acute respiratory failure (within one week from surgery)
- after cardiac arrest
- chronic hypoxemic respiratory failure
- hypercapnic respiratory failure
- no full code
- lack of equipoise of the clinical team
- lack of informed consent
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Number of arms
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Evangelismos Hospital
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Inclusion age min
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Greece
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Type of patients
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Critical disease at enrollment
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Severity scale
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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8: Critical disease at enrollment
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Total sample size
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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80
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primary outcome
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Time from onset of severe acute hypoxemic respiratory failure to intubation
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Notes
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Nov. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 429, "treatment_name": "Early endotracheal intubation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 393, "treatment_name": "Delayed endotracheal intubation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]
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