Clinical trial NCT05399017: Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients
Official title: Open-labeled, Non-randomized, Self-controlled Study to Evaluate the Safety and Performance of EZVent in Hospitalized Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Respiratory Disease
Keywords: EZVent
Ventilator
Mechanical Ventilator
Respiratory failure
medical device
ventilator performance
Egyptian ventilator
ventilator clinical evaluation
ventilator clinical investigation
EZVent clinical evaluation
Lead sponsor: Triclinium Clinical Development Middle East and North Africa
Sponsor class: OTHER
Collaborators: name: ezz medical Industries
First posted: 2022-06-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, open-labeled, self-control study, single arm.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Comparable gas exchange parameters
timeFrame: 0-120 minutes
measure: Comparable gas exchange parameters
timeFrame: 0-120 minutes
measure: Comparable gas exchange parameters
timeFrame: 0-120 minutes
measure: Comparable gas exchange parameters
timeFrame: 0-120 minutes
measure: Comparable hemodynamic and vital parameters
timeFrame: 0-120 minutes
measure: Comparable hemodynamic and vital parameters
timeFrame: 0-120 minutes
measure: Comparable hemodynamic and vital parameters
timeFrame: 0-120 minutes
measure: Comparable hemodynamic and vital parameters
timeFrame: 0-120 minutes
measure: Comparable lung mechanics parameters
timeFrame: 0-120 minutes
measure: Comparable lung mechanics parameters
timeFrame: 0-120 minutes
measure: Comparable lung mechanics parameters
timeFrame: 0-120 minutes
measure: Comparable lung mechanics parameters
timeFrame: 0-120 minutes
measure: Comparable lung mechanics parameters
timeFrame: 0-120 minutes
measure: Comparable lung mechanics parameters
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Serious adverse events
timeFrame: 0-120 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Critical Care Unit of Kasr Al-Ainy Hospital
Study officials:
affiliation: Kasr El Aini Hospital
name: Yasser Nassar, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References: