Respiratory Failure Clinical Trial
Official title:
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
NCT number | NCT04030208 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 4, 2018 |
Est. completion date | December 31, 2019 |
Verified date | August 2020 |
Source | Umbulizer LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical ventilators
Status | Completed |
Enrollment | 24 |
Est. completion date | December 31, 2019 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Services Hospital | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Umbulizer LLC |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | O2 Saturation | O2 saturation (from pulse oximeter) when patient is on Umbulizer compared to when patient is on a traditional mechanical ventilator | 2 hours | |
Primary | 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 | |
Primary | 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 | |
Secondary | Number of Adverse Events | Number of adverse events on Umbulizer compared to on a traditional ventilator | 2 hours |
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