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| Name | Class |
|---|---|
| ezz medical Industries | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZVent | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZVent | 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparable gas exchange parameters | 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). | 0-120 minutes |
| Comparable gas exchange parameters | Comparable gas exchange parameters ( Blood pH values) 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) | 0-120 minutes |
| Comparable gas exchange parameters | Comparable gas exchange parameters (PaO2) 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) | 0-120 minutes |
| Comparable gas exchange parameters | Comparable gas exchange parameters (SaO2) 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) | 0-120 minutes |
| Comparable hemodynamic and vital parameters | Comparable hemodynamic and vital parameters (Blood pressure) at T2 when the patient is on EZVent in relation to at T0 | 0-120 minutes |
| Comparable hemodynamic and vital parameters | Comparable hemodynamic and vital parameters (pulse) at T2 when the patient is on EZVent in relation to at T0 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | Serious adverse events (cardiac arrest, pneumothorax, Cardiac tamponade or any other serious medical event) | 0-120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa Salah, Ph.MSc | Contact | +201062256804 | reg.tcdmena@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yasser Nassar, Prof.Dr | Kasr El Aini Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Critical Care Unit of Kasr Al-Ainy Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Non-randomized, open-labeled, self-control study, single arm.
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| 0-120 minutes |
| Comparable hemodynamic and vital parameters | Comparable hemodynamic and vital parameters (Temperature) at T2 when the patient is on EZVent in relation to at T0 | 0-120 minutes |
| Comparable hemodynamic and vital parameters | Comparable hemodynamic and vital parameters (Respiratory rate) at T2 when the patient is on EZVent in relation to at T0 | 0-120 minutes |
| Comparable lung mechanics parameters | Comparable lung mechanics parameters (Static Compliance) at T2 when patient was on EZVent in relation to readings at T0 | 0-120 minutes |
| Comparable lung mechanics parameters | Comparable lung mechanics parameters (Airway resistance) at T2 when patient was on EZVent in relation to readings at T0 | 0-120 minutes |
| Comparable lung mechanics parameters | Comparable lung mechanics parameters (Tidal volume) at T2 when patient was on EZVent in relation to readings at T0 | 0-120 minutes |
| Comparable lung mechanics parameters | Comparable lung mechanics parameters (Mean Airway Pressure) at T2 when patient was on EZVent in relation to readings at T0 | 0-120 minutes |
| Comparable lung mechanics parameters | Comparable lung mechanics parameters (Plateau) at T2 when patient was on EZVent in relation to readings at T0 | 0-120 minutes |
| Comparable lung mechanics parameters | Comparable lung mechanics parameters (Peak) at T2 when patient was on EZVent in relation to readings at T0 | 0-120 minutes |