Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

Not Applicable

• Conditions: Respiratory Disease; Respiratory Failure
• Interventions: Device: EZVent

• Registration Number: NCT05399017
• Lead Sponsor: Triclinium Clinical Development Middle East and North Africa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-29
• Status Verified: 2022-06
• Study First Posted: 2022-06-01
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-03
• Study Start: 2022-08-01
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EZVent	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).

Primary Outcome Measures

Name	Time	Method
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 (Peak) at T2 when patient was on EZVent in relation to readings at T0
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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Critical Care Unit of Kasr Al-Ainy Hospital; 🇪🇬 Cairo, Egypt