Respiratory Arrest, Respiratory Failure, Respiratory Insufficiency
Conditions
Keywords
respiratory disease, low resource settings, mechanical ventilation, ventilator performance, comparative study, patient safety, ease of use
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
Interventions
DEVICEUmbulizer
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.
DEVICETraditional Mechanical Ventilator
A medical device designed to artificially perform breathing functions for patients who are unable to adequately perform these functions on their own.
Sponsors
Umbulizer LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 2 hours | Number of adverse events on Umbulizer compared to on a traditional ventilator |
Other
| Measure | Time frame | Description |
|---|---|---|
| Level of Comfort | 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). |
| O2 Saturation | 2 hours | O2 saturation (from pulse oximeter) when patient is on Umbulizer compared to when patient is on a traditional mechanical ventilator |
| Ease of Use | 2 hours | Umbulizer's ease of use will be determined based on survey responses by doctors/medical staff at the end of each experiment |
| Partial Pressure of Oxygen (PaO2) | 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 |
Countries
Pakistan
Outcome results
None listed