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

Umbulizer LLC24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Respiratory Failure Respiratory Insufficiency Respiratory Arrest

Interventions

UmbulizerDEVICE

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 VentilatorDEVICE

A medical device designed to artificially perform breathing functions for patients who are unable to adequately perform these functions on their own.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Services Hospital

Lahore, Punjab Province, Pakistan

Outcomes

Primary Outcomes

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

Time frame: 2 hours

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

Time frame: 2 hours

Secondary Outcomes

Number of Adverse Events

Number of adverse events on Umbulizer compared to on a traditional ventilator

Time frame: 2 hours

Data from ClinicalTrials.gov

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