Respiratory Disease, Respiratory Failure
Conditions
Keywords
EZVent, Ventilator, Mechanical Ventilator, Respiratory failure, medical device, ventilator performance, Egyptian ventilator, ventilator clinical evaluation, ventilator clinical investigation, EZVent clinical evaluation
Brief summary
Investigation Device: EZVent Ventilator System is designed for respiratory support in hospitalized mechanical ventilated patients. The Ventilator is designed to be used for adults patients. It is designed to be a stationary product suitable for service in hospitals, critical care situations to provide continuous positive pressure respiratory support to the patient. The ventilator met EDA, ISO 80601-2-12 requirements on essential performance of critical care ventilator and other applicable international standards. Study Title: Open-labeled, non-randomized, self-controlled study to evaluate the safety and performance of EZVent in hospitalized mechanically ventilated patients. Investigational Device EZVent Ventilator System. Purpose: Evaluation of the safety and performance of EZVent in hospitalized mechanically ventilated patients. Objectives: Evaluation of the safety and performance of EZVent through monitoring the vital signs and arterial blood gases (ABG) in comparison to a commercial ventilator.
Interventions
DEVICEEZVent
EZVent Ventilator System is designed for respiratory support in hospitalized mechanical ventilated patients. The Ventilator is designed to be used for adults patients. It is designed to be a stationary product suitable for service in hospitals, critical care situations to provide continuous positive pres- sure respiratory support to the patient. The ventilator met EDA, ISO 80601-2-12 requirements on essential performance of critical care ventilator and other applicable international standards.
Sponsors
ezz medical Industries
Triclinium Clinical Development Middle East and North Africa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Non-randomized, open-labeled, self-control study, single arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female, aged 18 years or above. * Mechanically ventilated Patients (on either VC, PC or CPAP modes). * Able (in the Investigators opinion) and willing to comply with all study requirements. * Considered clinically stable, with FiO2 less than 60% and PEEP no greater than 10 cm H2O
Exclusion criteria
* Pregnant Women * Patients who experienced myocardial infarction within the last 6 weeks. * Shocked patients, Hemodynamic instability requiring vasopressors, cardiac arrhythmias, terminal malignancy. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparable gas exchange parameters | 0-120 minutes | Comparable gas exchange parameters (PaCO2) at T2 (120 minutes after the patient was on EZVent) in relation to readings at T0 (Baseline readings when the patient was connected to his/ her original standard traditional mechanical ventilator). |
| Comparable hemodynamic and vital parameters | 0-120 minutes | Comparable hemodynamic and vital parameters (Blood pressure) at T2 when the patient is on EZVent in relation to at T0 |
| Comparable lung mechanics parameters | 0-120 minutes | Comparable lung mechanics parameters (Static Compliance) at T2 when patient was on EZVent in relation to readings at T0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | 0-120 minutes | Serious adverse events (cardiac arrest, pneumothorax, Cardiac tamponade or any other serious medical event) |
Countries
Egypt
Contacts
Primary ContactMostafa Salah, Ph.MSc
Outcome results
None listed