Clinical trial NCT04030208: Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
Official title: Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Respiratory Insufficiency
Respiratory Arrest
Keywords: respiratory disease
low resource settings
mechanical ventilation
ventilator performance
comparative study
patient safety
ease of use
Lead sponsor: Umbulizer LLC
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: Partial Pressure of Carbon Dioxide (PaCO2)
timeFrame: 2 hours
measure: pH
timeFrame: 2 hours
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 2 hours
Other outcomes:
measure: Level of Comfort
timeFrame: 2 hours
measure: Ease of Use
timeFrame: 2 hours
measure: Partial Pressure of Oxygen (PaO2)
timeFrame: 2 hours
measure: O2 Saturation
timeFrame: 2 hours
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital
state: Punjab
Study officials:
affiliation: Services Hospital
name: Kamran Chima, MBBS
role: PRINCIPAL_INVESTIGATOR
References: