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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Respiratory Insufficiency; Respiratory Arrest
• Intervention / Treatment: Device: Umbulizer; Device: Traditional Mechanical Ventilator

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence A; 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.	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.
Other: Sequence B; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	Number of adverse events on Umbulizer compared to on a traditional ventilator	2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
O2 Saturation	O2 saturation (from pulse oximeter) when patient is on Umbulizer compared to when patient is on a traditional mechanical ventilator	2 hours

Collaborators and Investigators

• Sponsor: Umbulizer LLC
• Investigators: Principal Investigator: Kamran Chima, MBBS, Services Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 21, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: mechanical ventilation; respiratory disease; patient safety; low resource settings; ventilator performance; comparative study; ease of use
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No