Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Corona Virus Disease, Noninvasive Ventilation
Conditions
Brief summary
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)
Interventions
DEVICENon invasive ventilation via helmet
Patients requiring long hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet
Sponsors
Hamad Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with (Acute Respiratory Distress Syndrome) ARDS as per Berlin definition * Age: 18 and more
Exclusion criteria
* Patients with altered sensorium \[Glasgow Coma Scale (GCS) less than 13\] * Pregnancy * Hemodynamic instability * Morbidly obese * Patients with tracheostomy * Severe acidosis \[PH less than 7.15\] * Patients with glaucoma * Patients with history of vertigo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for Endotracheal Intubation | 6 weeks | Number of patients requiring endotracheal intubation after application of helmet device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free Days | 28 days | Duration of mechanical ventilation via endotracheal tube |
| Intensive Care Unit Length of Stay | 4 weeks | Number of days admitted to intensive care unit |
| Overall Mortality | 90 days | Death from any cause during hospitalization at time of enrollment |
| Improvement in Oxygen Saturation | 2 weeks | Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100 |
| Intensive Care Unit Mortality | 28 days | Death from any cause during ICU hospitalization at time of enrollment |
| Patient Tolerability | 28 days from randomization | the degree to which overt adverse effects of a drug can be tolerated by a patient including feeding tolerance |
| Need for Proning | up to 24 weeks | Need for proning during the hospital stay |
Countries
Qatar
Contacts
Primary ContactMohamed Z Peediyakkal, MD
Backup ContactAbdulqadir J Nashwan, MSc
Outcome results
None listed