COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04477668

None

None

2020-07-20

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - suspected or confirmed covid-19 - aged ≥14 years old at the participating icu. icus that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years) - acute hypoxemic respiratory failure based on pao2/fio2 ratio <200 despite supplemental oxygen with a partial or non-rebreathing mask at a flow rate >10 l/min or above - intact airway protective gag reflex - able to follow instructions (e.g. squeeze hand on command, eye contact with care provider, stick out tongue on command, etc.)

- prior intubation during this hospital admission - cardiopulmonary arrest - glasgow coma scale <12 - tracheostomy - upper airway obstruction - active epistaxis - requirement for more than one vasopressor to maintain mean arterial pressure > 65 mm hg - pregnancy - imminent intubation - patients with do not intubate orders or equivalent - enrolled in another trial for which co-enrolment is not approved including trials on mechanical ventilation - patients already treated with helmet - patients with chronic carbon dioxide retention (paco2 >45) - previous enrolment in this trial - the primary cause of respiratory failure is not heart failure as judged by the treating team

2

King Abdullah International Medical Research Center

14

100

Saudi Arabia

Severe disease at enrollment

6: Severe disease at enrollment

322

28-day all-cause mortality

None

Not reported

[{"arm_notes": "", "treatment_id": 565, "treatment_name": "Helmet non-invasive ventilation", "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"}]