The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute Respiratory Distress Syndrome (ARDS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients requiring long hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet
Hazm Mebaireek General Hospital (HMGH)
Doha, Qatar
Need for Endotracheal Intubation
Number of patients requiring endotracheal intubation after application of helmet device
Time frame: 6 weeks
Improvement in Oxygen Saturation
Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
Time frame: 2 weeks
Ventilator-free Days
Duration of mechanical ventilation via endotracheal tube
Time frame: 28 days
Intensive Care Unit Length of Stay
Number of days admitted to intensive care unit
Time frame: 4 weeks
Overall Mortality
Death from any cause during hospitalization at time of enrollment
Time frame: 90 days
Need for Proning
Need for proning during the hospital stay
Time frame: up to 24 weeks
Intensive Care Unit Mortality
Death from any cause during ICU hospitalization at time of enrollment
Time frame: 28 days
Patient Tolerability
the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance
Time frame: 28 days from randomization
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