Respiratory Failure Clinical Trial
Official title:
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical ventilators
Mechanical ventilators cost tens of thousands of dollars, rendering them difficult for low
and middle income countries to procure. Given chronic shortages of these devices in places
like Pakistan, patients are often ventilated manually with Ambu Bags for hours or days. This
method is not suitable for long term ventilation and is extremely life threatening.
Umbulizer seeks to reduce preventable deaths due to ventilator scarcity by providing a
reliable alternative. The device is accurate, low-cost, and portable, and is an ideal
solution for treating patients with respiratory diseases in low-resource settings. The
primary objective of this study is to test efficacy and determine non-inferiority of this
device in comparison to ventilation provided by traditional ventilators. Secondary objectives
of this study include:
1. Testing safety of the device for use over a predetermined period of time
2. Evaluating patient comfort during ventilation with this device
3. Assessing ease of use of this device for doctors and medical staff
;
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