Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Other | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbulizer | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Number of adverse events on Umbulizer compared to on a traditional ventilator | 2 hours |
| 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 |
Inclusion Criteria:
1) Patients needing mechanical ventilation
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kamran Chima, MBBS | Services Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Hospital | Lahore | Punjab Province | Pakistan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Traditional Mechanical Ventilator | Device | A medical device designed to artificially perform breathing functions for patients who are unable to adequately perform these functions on their own. |
|
| 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 |