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Clinical Trial Summary

Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical ventilators


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04030208
Study type Interventional
Source Umbulizer LLC
Contact
Status Completed
Phase N/A
Start date September 4, 2018
Completion date December 31, 2019

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