Non-Invasive Ventilation Via a Helmet Device for Patients With Shock and/or Hypoxemic Respiratory Failure

• Need for endotracheal intubation [ Time Frame: Measured during hospitalization, expected time frame to be up to 6weeks ] [ Designated as safety issue: No ]
  Percentage of patients requiring endotracheal intubation after application of helmet device
  
  
• Intensive care unit length of stay [ Time Frame: Measured during hospitalization, expected to be at most 4 weeks ] [ Designated as safety issue: No ]
  Number of days admitted to a medical intensive care unit
  
  

• ICU complications [ Time Frame: measured time to event data during hospitalization, estimated to be 6 weeks ] [ Designated as safety issue: No ]
  ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness
  
  
• Hospital length of stay [ Time Frame: measured during hospitalization expected to be on average 6 weeks or less ] [ Designated as safety issue: No ]
  Days spent in hospital at time of enrollment
  
  
• Readmission to the intensive care unit [ Time Frame: measured during hospitalization, expected to be on average up to 6 weeks ] [ Designated as safety issue: No ]
  Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment
  
  
• Discharge location [ Time Frame: collected on day of discharge from hospitalization, expected average of 6 weeks ] [ Designated as safety issue: Yes ]
  Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to
  
  
• Functional status after discharge [ 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) ] [ Designated as safety issue: No ]
  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)
  
  
• Improvement of oxygenation [ Time Frame: Measured during mechanical ventilation via endotracheal intubation or non-invasive ventilation via helmet, expected time frame of about 2 weeks ] [ Designated as safety issue: No ]
  Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
  
  
• Ventilator days [ Time Frame: measured during hospitalization with expected time frame of 2 weeks ] [ Designated as safety issue: No ]
  Duration of mechanical ventilation via endotracheal tube
  
  
• Hospital mortality [ Time Frame: measured during hospitalization with expected time frame of 6 weeks ] [ Designated as safety issue: Yes ]
  Death from any cause during hospitalization at time of enrollment
  
  

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.