Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

Triclinium Clinical Development Middle East and North Africa22 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Respiratory Failure Respiratory Disease

EZVentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Critical Care Unit of Kasr Al-Ainy Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

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).

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 0-120 minutes