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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04030208
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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