| Trial registration number
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NCT05178160 |
Full text link
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05178160
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First author
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Fabio G Numis, MD
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Contact
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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2022-01-05
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Recruitment status
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
age > 18 years;
diagnosis of sars-cov-2 infection confirmed by means of rt-pcr on specimen from nasopharyngeal swab;
bilateral interstitial pneumonia at ct scan;
hypoxemic respiratory failure defined as pao2/fio2 < 200 at blood gas analyses.
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Exclusion criteria
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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type 2 respiratory failure;
hemodynamic instability requiring vasopressors and/or inotropes support;
ct evidence of pneumothorax/pneumomediastinum;
concomitant acute medical disease (stroke; myocardial infarction; septic shock; gastrointestinal bleeding; acute renal failure requiring dialysis)
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Number of arms
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Santa Maria delle Grazie Hospital
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Inclusion age min
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Italy
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Type of patients
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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60
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primary outcome
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Primary outcome
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Notes
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 2106, "treatment_name": "Lung ultrasound-guided peep titration", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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