Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Respiratory Disease
• Intervention / Treatment: Device: EZVent

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Salah, Ph.MSc; Phone Number: +201062256804; Email: reg.tcdmena@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Critical Care Unit of Kasr Al-Ainy Hospital
    • Principal Investigator: Yasser Nassar, Prof.Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EZVent; Subjects who are involved in the clinical trial are already mechanically ventilated on traditional standard commercial ventilator. Baseline measurements (T0) will be taken from each patient before being transferred to EZVent ventilator. The following measurements will be taken: Vital Signs and hemodynamics (heart rate, blood pressure, temperature, Respiratory rate), Chest X-ray, Arterial blood gases as well as the ventilator mode parameters (dependent on each mode) and lung mechanics parameters (Peak, Plateau, Mean Airway Pressure, Tidal Volume, Airway Resistance and Static Compliance).; After taking the baseline measurements, subjects will be disconnected from their traditional standard ventilator and immediately connected to EZVent using the same previous original setting.; After 60 & 120 minutes of ventilation on EZVent (T1&T2) respectively, the same measurement will be taken (Vital signs and Hemodynamics will be continuously monitored and recorded every five minutes).

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.; Other Names: EZVent Ventilator System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Serious adverse events (cardiac arrest, pneumothorax, Cardiac tamponade or any other serious medical event)	0-120 minutes

Collaborators and Investigators

• Sponsor: Triclinium Clinical Development Middle East and North Africa
• Collaborators: ezz medical Industries
• Investigators: Principal Investigator: Yasser Nassar, Prof.Dr, Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: medical device; Ventilator; Respiratory failure; ventilator performance; Mechanical Ventilator; EZVent; Egyptian ventilator; ventilator clinical evaluation; ventilator clinical investigation; EZVent clinical evaluation
• Additional Relevant MeSH Terms: Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: MD-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No