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NCT05399017 Clinical Trial

Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

Respiratory Failure Clinical Trial

Official title:
Open-labeled, Non-randomized, Self-controlled Study to Evaluate the Safety and Performance of EZVent in Hospitalized Mechanically Ventilated Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05399017
Other study ID # MD-004
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date August 30, 2022

Study information
Verified date June 2022
Source Triclinium Clinical Development Middle East and North Africa
Contact Mostafa Salah, Ph.MSc
Phone +201062256804
Email reg.tcdmena@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 22
Est. completion date August 30, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• EZVent
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.

Locations
Country Name City State
Egypt Critical Care Unit of Kasr Al-Ainy Hospital Cairo

Sponsors (2)
Lead Sponsor Collaborator
Triclinium Clinical Development Middle East and North Africa ezz medical Industries

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Comparable hemodynamic and vital parameters Comparable hemodynamic and vital parameters (pulse) at T2 when the patient is on EZVent in relation to at T0 0-120 minutes
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Secondary Serious adverse events Serious adverse events (cardiac arrest, pneumothorax, Cardiac tamponade or any other serious medical event) 0-120 minutes
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