Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

NCT ID: NCT05399017

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2022-08-30

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.

Conditions

Respiratory Failure; Respiratory Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

EZVent

Intervention Type: 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 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

EZVent Ventilator System

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ezz medical Industries

UNKNOWN

Sponsor Role: collaborator

Triclinium Clinical Development Middle East and North Africa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yasser Nassar, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Kasr El Aini Hospital

Locations

Critical Care Unit of Kasr Al-Ainy Hospital

Cairo, , Egypt

Countries

Egypt

Central Contacts

Mostafa Salah, Ph.MSc

Role: CONTACT

reg.tcdmena@gmail.com

+201062256804

Other Identifiers

MD-004

Identifier Type: -

Identifier Source: org_study_id