Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
NCT04030208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2020-08-06
Summary
Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical ventilators
Conditions
- Respiratory Failure
- Respiratory Insufficiency
- Respiratory Arrest
Interventions
- 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.
Sponsors & Collaborators
-
Umbulizer LLC
lead INDUSTRY
Principal Investigators
-
Kamran Chima, MBBS · Services Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-04
- Primary Completion
- 2019-11-30
- Completion
- 2019-12-31
Countries
- Pakistan
Study Locations
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