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

Not Applicable

Completed

• Conditions: Respiratory Failure; Respiratory Insufficiency; Respiratory Arrest
• Interventions: Device: Umbulizer; Device: Traditional Mechanical Ventilator

• Registration Number: NCT04030208
• Lead Sponsor: Umbulizer LLC

Brief 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

Study Timeline

• Study Start: 2018-09-04
• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-21
• Study First Posted: 2019-07-23
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Umbulizer	If patient is randomly assigned to Sequence A, they will be placed on a traditional ventilator for the first period. This period will be 1 hour in duration. Delivered tidal volume, respiratory rate (RR), and peak pressure will be recorded throughout the period using the ventilator. Heart rate (HR), Blood Pressure (BP), and oxygen (O2) saturation measurements will be recorded every 5 minutes. Arterial blood gas (ABG) data will be taken at t = 1 hour if the patient is stable on the traditional ventilator. ABGs may be taken more frequently if the patient is destabilizing. Next, the study participant will be transitioned to the Umbulizer to begin Period 2. This period will also be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using Umbulizer. HR, BP, O2 saturation measurements will be taken every 5 minutes. ABG data will be taken at t = 30 minutes and 1 hour.
Sequence A	Traditional Mechanical Ventilator	If patient is randomly assigned to Sequence A, they will be placed on a traditional ventilator for the first period. This period will be 1 hour in duration. Delivered tidal volume, respiratory rate (RR), and peak pressure will be recorded throughout the period using the ventilator. Heart rate (HR), Blood Pressure (BP), and oxygen (O2) saturation measurements will be recorded every 5 minutes. Arterial blood gas (ABG) data will be taken at t = 1 hour if the patient is stable on the traditional ventilator. ABGs may be taken more frequently if the patient is destabilizing. Next, the study participant will be transitioned to the Umbulizer to begin Period 2. This period will also be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using Umbulizer. HR, BP, O2 saturation measurements will be taken every 5 minutes. ABG data will be taken at t = 30 minutes and 1 hour.
Sequence B	Umbulizer	If patient is randomly assigned to Sequence B, they will be shifted to the Umbulizer for the first period. This period will be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using Umbulizer. HR, BP, O2 saturation measurements will be recorded every 5 minutes. ABG data will be taken at t = 30 minutes and 1 hour. Next, the study participant will be transitioned to a traditional ventilator to begin Period 2. This period will also be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using the ventilator. HR, BP, O2 saturation measurements will be recorded every 5 minutes. ABG data will be taken at t = 1 hour if the patient is stable on the traditional ventilator. ABGs may be taken more frequently if the patient is destabilizing.
Sequence B	Traditional Mechanical Ventilator	If patient is randomly assigned to Sequence B, they will be shifted to the Umbulizer for the first period. This period will be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using Umbulizer. HR, BP, O2 saturation measurements will be recorded every 5 minutes. ABG data will be taken at t = 30 minutes and 1 hour. Next, the study participant will be transitioned to a traditional ventilator to begin Period 2. This period will also be 1 hour in duration. Delivered tidal volume, RR, and peak pressure will be recorded throughout the period using the ventilator. HR, BP, O2 saturation measurements will be recorded every 5 minutes. ABG data will be taken at t = 1 hour if the patient is stable on the traditional ventilator. ABGs may be taken more frequently if the patient is destabilizing.

Primary Outcome Measures

Name	Time	Method
pH	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
Partial Pressure of Carbon Dioxide (PaCO2)	2 hours	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

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	2 hours	Number of adverse events on Umbulizer compared to on a traditional ventilator

Trial Locations

Locations (1)

Services Hospital; 🇵🇰 Lahore, Punjab, Pakistan