The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.
Respiratory failure is often treated with endotracheal intubation and mechanical ventilation. Although, the institution of mechanical ventilation is considered life saving, the associated complications of tracheal stenosis, ventilator associated pneumonia, barotrauma , and neuromuscular weakness are not without considerable morbidity and mortality. Non-invasive ventilation has demonstrated significant benefit in patients with hypercapnic respiratory failure from COPD, acute cardiogenic pulmonary edema, and hypoxemic respiratory failure in immunocompromised patients. Despite the advantages of non-invasive ventilation via facemask, some patients fail because of mask intolerance and severity of disease. Further limitation to facemask non-invasive ventilation is that the seal integrity is lost when higher pressures are required. Unfortunately, certain types of respiratory failure such as that due to hypoxemia or shock may require such higher pressures. In an attempt to improve patient tolerability and deliver higher pressures, a transparent helmet has been proposed as a novel interface for non-invasive ventilation. It encloses the entire head and neck of the patient. The design of the helmet confers some important advantages: 1) the transparency allows the patient to interact with the environment; 2) the lack of contact to the face lowers the risk of skin necrosis; 3) the helmet avoids problems of leaking with higher airway pressures that are seen with the face mask; 4) it can be applied to any patient regardless of facial contour.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
University of Chicago Medical Center
Chicago, Illinois, United States
Need for Endotracheal Intubation
Number of patients requiring endotracheal intubation after application of helmet device
Time frame: 6 weeks
Hospital Length of Stay
Days spent in hospital at time of enrollment
Time frame: Duration of hospital stay
Number of Participants Functional Status After Discharge
Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)
Time frame: Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)
Ventilator-free Days
Duration of mechanical ventilation via endotracheal tube
Time frame: number of days in the hospital
Hospital Mortality
Death from any cause during hospitalization at time of enrollment
Time frame: 90 days
Intensive Care Unit Length of Stay
Number of days admitted to a medical intensive care unit
Time frame: 4 weeks
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