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Trial - NCT04543760


Column Value
Trial registration number NCT04543760
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04543760

First author
Last imported at : May 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Hospital St. Joseph, Marseille, France

Contact
Last imported at : May 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-10

Recruitment status
Last imported at : May 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Crossover

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - aged ≥ 18 years, - admitted to icu within 72 hours, - having confirmed or highly suspected covid-19 infection (positive rt-pcr and/or computed tomography), - having acute hypoxemic respiratory failure with a [pao2/fio2] ratio between 100 mmhg and 300 mmhg, - having given free and informed written consent, - being affiliated with or benefiting from a social security scheme.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- unable to achieve a prone position for mobility reasons, - unable to achieve a prone position due to agitation whatever the cause, - with clinical occlusive syndrome in order to limit the risk of inhalation, - having a contraindication to the use of the esophageal catheter, - having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours, - having hypercapnia indicating the use of non-invasive ventilation (pao2> 50 mmhg), - having severe hypoxemia defined by pao2 / fio2 <100mmhg, - ongoing pregnancy or breastfeeding, - subject to a measure for the protection of justice.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Hospital St. Joseph, Marseille, France

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

France

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

8: Critical disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[PaO2 / FiO2] ratio

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1027, "treatment_name": "Prone position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1247, "treatment_name": "Supine position", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]