Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

Sponsor

Triclinium Clinical Development Middle East and North Africa (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05399017

Collaborator

ezz medical Industries (Other)

Enrollment

Location

Arm

Anticipated Duration (Days)

23.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure Respiratory Disease	Device: EZVent	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Non-randomized, open-labeled, self-control study, single arm.Non-randomized, open-labeled, self-control study, single arm.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 15, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 gas exchange parameters [0-120 minutes]
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)
Comparable gas exchange parameters [0-120 minutes]
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)
Comparable gas exchange parameters [0-120 minutes]
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)
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 hemodynamic and vital parameters [0-120 minutes]
Comparable hemodynamic and vital parameters (pulse) at T2 when the patient is on EZVent in relation to at T0
Comparable hemodynamic and vital parameters [0-120 minutes]
Comparable hemodynamic and vital parameters (Temperature) at T2 when the patient is on EZVent in relation to at T0
Comparable hemodynamic and vital parameters [0-120 minutes]
Comparable hemodynamic and vital parameters (Respiratory rate) 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
Comparable lung mechanics parameters [0-120 minutes]
Comparable lung mechanics parameters (Airway resistance) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters [0-120 minutes]
Comparable lung mechanics parameters (Tidal volume) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters [0-120 minutes]
Comparable lung mechanics parameters (Mean Airway Pressure) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters [0-120 minutes]
Comparable lung mechanics parameters (Plateau) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters [0-120 minutes]
Comparable lung mechanics parameters (Peak) at T2 when patient was on EZVent in relation to readings at T0

Secondary Outcome Measures

Serious adverse events [0-120 minutes]
Serious adverse events (cardiac arrest, pneumothorax, Cardiac tamponade or any other serious medical event)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.