Status:
COMPLETED
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
Lead Sponsor:
Umbulizer LLC
Conditions:
Respiratory Failure
Respiratory Insufficiency
Eligibility:
All Genders
18-85 years
Phase:
NA
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, pat...
Eligibility Criteria
Inclusion
- 1\) Patients needing mechanical ventilation
Exclusion
- Patients with significant airway resistance (i.e. severe chronic obstructive pulmonary disease or asthma) where clinical investigator is concerned about gas trapping or barotrauma
- 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
- Patients who experienced a myocardial infarction within the last 6 weeks
- Patients who are determined by a clinical investigator to be too hemodynamically unstable to be enrolled
Key Trial Info
Start Date :
September 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04030208
Start Date
September 4 2018
End Date
December 31 2019
Last Update
August 6 2020
Active Locations (1)
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1
Services Hospital
Lahore, Punjab Province, Pakistan