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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Diseases

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