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Helmet non-invasive ventilationWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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There is one clinical trial.

Clinical Trials


1 Helmet Non-Invasive Ventilation for COVID-19 Patients

Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure

NCT04477668 COVID-19 Acute Hypoxemic Respiratory Failure Device: Helmet non-invasive ventilation
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: all cause mortality

Measure: 28-day all-cause mortality

Time: 28 days from randomization

Secondary Outcomes

Description: endotracheal intubation

Measure: Requirement for endotracheal intubation within 28 days

Time: 28 days from randomization

Description: ICU death

Measure: ICU mortality

Time: 180 days from randomization

Description: hospital death

Measure: Hospital mortality

Time: 180 days from randomization

Description: days not in ICU

Measure: ICU free days at day 28

Time: 28 days from randomization

Description: days without ventilator support

Measure: Ventilator free days at day 28

Time: 28 days from randomization

Description: days without renal replacement therapy received

Measure: Renal replacement therapy free days at day 28

Time: 28 days from randomization

Description: days without vasopressor support

Measure: Vasopressor free days at day 28

Time: 28 days from randomization

Description: presence of pressure ulcers

Measure: Skin pressure ulcers

Time: 28 days from randomization

Description: tolerance to intervention

Measure: Tolerance of helmet (>1-hour use)

Time: 28 days from randomization

Description: vital status

Measure: 180-day mortality

Time: 180 days from randomization

Description: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Measure: 180-day 5-level EQ-5D version

Time: 180 days from randomization


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