Trial registration number
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NCT04821973 |
Full text link
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04821973
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First author
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Pierre MICHELET
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Contact
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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pierre.michelet@ap-hm.fr
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Registration date
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-03-30
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Recruitment status
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : April 1, 2021, 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 : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- patient with covid 19 pneumonia assessed by pcr and ct scann.
- patient admited in a dedicated medical ward
- patient with oxygen supply less or equal to 4 liters per minute.
- written informed consent
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Exclusion criteria
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- patient with limitation of care.
- patient with immediate risk to icu transfer within the first 12 hours
- patient with neurological or psychiatric symptoms that interfere with respiratory
parameters interpretation.
- patient with acute or chronic respiratory disease such as copd, cancer.
- pregnancy, age < 18 of vulnerable profile.
- patient refusal to participate or previously included in a clinical research trial.
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Number of arms
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Assistance Publique Hopitaux De Marseille
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Inclusion age min
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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10
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Inclusion age max
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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France
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Type of patients
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Moderate disease at enrollment
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Severity scale
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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3: Moderate disease at enrollment
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Total sample size
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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80
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primary outcome
Last imported at : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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respiratory degradation event 1;respiratory degradation event 2
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Notes
Last imported at : April 1, 2021, 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 : April 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": " ", "treatment_id": 1057, "treatment_name": "Radius ppg tetherless pulse oximetry", "treatment_type": "Medical device", "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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