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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030208
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Umbulizer LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1) Patients needing mechanical ventilation

Exclusion Criteria:

1. Patients with significant airway resistance (i.e. severe chronic obstructive pulmonary disease or asthma) where clinical investigator is concerned about gas trapping or barotrauma

2. Patients with very low lung compliance (i.e. severe acute respiratory distress syndrome or restrictive disease) where clinical investigator is concerned about problems delivering sufficient tidal volume or end expiratory pressure

3. Patients who experienced a myocardial infarction within the last 6 weeks

4. Patients who are determined by a clinical investigator to be too hemodynamically unstable to be enrolled

Related Conditions & MeSH terms

• Apnea
• Pulmonary Valve Insufficiency
• Respiratory Arrest
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Services Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Umbulizer LLC

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of Comfort	Level of comfort on Umbulizer will be determined based on a 4-point scale assessing a combination of indicators (1 point will be assigned for the absence of each of the following: substantial deviation of heart rate from baseline, substantial deviation of blood pressure from baseline, grimacing, diaphoresis).	2 hours
Other	Ease of Use	Umbulizer's ease of use will be determined based on survey responses by doctors/medical staff at the end of each experiment	2 hours
Other	Partial Pressure of Oxygen (PaO2)	PaO2 in mmHg at t = 1 hr (from ABG readings) when patient is on Umbulizer compared to PaO2 at t = 1 hr when patient is on a traditional mechanical ventilator	2 hours
Other	O2 Saturation	O2 saturation (from pulse oximeter) when patient is on Umbulizer compared to when patient is on a traditional mechanical ventilator	2 hours
Primary	Partial Pressure of Carbon Dioxide (PaCO2)	PaCO2 in mmHg at t = 1 hr (from Arterial Blood Gas or ABG readings) when patient is on Umbulizer compared to PaCO2 at t = 1 hr when patient is on a traditional mechanical ventilator	2 hours
Primary	pH	pH at t = 1 hr (from ABG readings) when patient is on Umbulizer compared to pH at t = 1 hr when patient is on a traditional mechanical ventilator	2 hours
Secondary	Number of Adverse Events	Number of adverse events on Umbulizer compared to on a traditional ventilator	2 hours