University of Chicago Medical Center
Chicago, Illinois, 60637, United States
NCT Number: NCT01680783
The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Chicago, Illinois, 60637, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Sea-Long medical treatment hood
Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
Other names: mechanical ventilation
Time frame: 6 weeks
Number of patients requiring endotracheal intubation after application of helmet device
Time frame: Duration of hospital stay
Days spent in hospital at time of enrollment
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)
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: number of days in the hospital
Duration of mechanical ventilation via endotracheal tube
Time frame: 90 days
Death from any cause during hospitalization at time of enrollment
Time frame: 4 weeks
Number of days admitted to a medical intensive care unit
Time frame: 6 weeks
ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness
Time frame: 6 weeks
Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment
Time frame: 6 weeks
Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to
Time frame: 2 weeks
Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100
University of Chicago
Other
Mechanical Ventilation in Patients With \Respiratory Failure: A Comparison of Face Mask and Non Invasive Ventilation Via a Helmet Device
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