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Trial - NCT04325906


Column Value
Trial registration number NCT04325906
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04325906

First author
Last imported at : April 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Jie Li

Contact
Last imported at : April 25, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Jie_Li@rush.edu

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

2020-03-30

Recruitment status
Last imported at : April 25, 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

Parallel

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

single-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: - covid-19 induced adult ards patients admitted to the medical icu - pao2/fio2 is less than 200mmhg or fio2 ≥ 0.4 is required to maintain spo2 at 88-93% on hfnc treatment

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

if the patients have a consistent spo2<80% when on evaluation with a fio2 of 0.6, or signs of respiratory fatigue (rr > 40/min, paco2> 50mmhg / ph<7.30, and obvious accessory respiratory muscle use); immediate need for intubation (pao2/fio2< 50mmhg or spo2/fio2 <90, unable to protect airway or mental status change); unstable hemodynamic status(sbp<90mmhg, mbp below 65 mmhg or requirement for vasopressor); unable to collaborate with hfnc/pp with agitation or refuse hfnc/pp. chest trauma or any contraindication for pp pneumothorax age < 18 years

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

Rush University Medical Center

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

None

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

United States

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

Moderate/severe disease at enrollment

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

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : March 1, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

224

primary outcome
Last imported at : March 1, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Mortality;Number of Participants With Intubation;Treatment Failure (Intubation or Death)

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": 575, "treatment_name": "High flow nasal cannula", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 576, "treatment_name": "High flow nasal cannula plus prone positioning", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}]