NCT04030208

Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Umbulizer LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Arrest

Interventions

Type	Name	Description
DEVICE	Umbulizer	Umbulizer is a reliable, user-friendly, and portable system that provides consistent air to the patient by quantitatively delivering a pre-determined tidal volume, inhale/exhale (I/E) ratio, peak pressure, and breathing rate (BPM). It can be configured to deliver either controlled ventilation or assist-controlled ventilation.
DEVICE	Traditional Mechanical Ventilator	A medical device designed to artificially perform breathing functions for patients who are unable to adequately perform these functions on their own.

Timeline

• Start date: 2018-09-04
• Primary completion: 2019-11-30
• Completion: 2019-12-31
• First posted: 2019-07-23
• Last updated: 2020-08-06

Locations

1 site across 1 country: Pakistan