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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04030208
Recruitment Status : Completed
First Posted : July 23, 2019
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Umbulizer LLC

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

Condition or disease Intervention/treatment Phase
Respiratory Failure Respiratory Insufficiency Respiratory Arrest Device: Umbulizer Device: Traditional Mechanical Ventilator Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Partial Pressure of Carbon Dioxide (PaCO2) [ Time Frame: 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

  2. pH [ 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


Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 hours ]
    Number of adverse events on Umbulizer compared to on a traditional ventilator


Other Outcome Measures:
  1. Level of Comfort [ Time Frame: 2 hours ]
    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. Ease of Use [ Time Frame: 2 hours ]
    Umbulizer's ease of use will be determined based on survey responses by doctors/medical staff at the end of each experiment

  3. Partial Pressure of Oxygen (PaO2) [ Time Frame: 2 hours ]
    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

  4. O2 Saturation [ Time Frame: 2 hours ]
    O2 saturation (from pulse oximeter) when patient is on Umbulizer compared to when patient is on a traditional mechanical ventilator



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030208


Locations
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Pakistan
Services Hospital
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Umbulizer LLC
Investigators
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Principal Investigator: Kamran Chima, MBBS Services Hospital
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Responsible Party: Umbulizer LLC
ClinicalTrials.gov Identifier: NCT04030208    
Other Study ID Numbers: 1
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Umbulizer LLC:
respiratory disease
low resource settings
mechanical ventilation
ventilator performance
comparative study
patient safety
ease of use
Additional relevant MeSH terms:
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Respiratory Insufficiency
Apnea
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory