NCT05399017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

14 days

First QC Date

May 24, 2022

Last Update Submit

June 2, 2022

Conditions

Respiratory FailureRespiratory Disease

Keywords

EZVentVentilatorMechanical VentilatorRespiratory failuremedical deviceventilator performanceEgyptian ventilatorventilator clinical evaluationventilator clinical investigationEZVent clinical evaluation

Outcome Measures

Primary Outcomes (14)

  • 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).

    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)

    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)

    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)

    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

    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

    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

    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

    0-120 minutes

  • Comparable lung mechanics parameters

    Comparable lung mechanics parameters (Static Compliance) at T2 when patient was on EZVent in relation to readings at T0

    0-120 minutes

  • Comparable lung mechanics parameters

    Comparable lung mechanics parameters (Airway resistance) at T2 when patient was on EZVent in relation to readings at T0

    0-120 minutes

  • Comparable lung mechanics parameters

    Comparable lung mechanics parameters (Tidal volume) at T2 when patient was on EZVent in relation to readings at T0

    0-120 minutes

  • Comparable lung mechanics parameters

    Comparable lung mechanics parameters (Mean Airway Pressure) at T2 when patient was on EZVent in relation to readings at T0

    0-120 minutes

  • Comparable lung mechanics parameters

    Comparable lung mechanics parameters (Plateau) at T2 when patient was on EZVent in relation to readings at T0

    0-120 minutes

  • Comparable lung mechanics parameters

    Comparable lung mechanics parameters (Peak) at T2 when patient was on EZVent in relation to readings at T0

    0-120 minutes

Secondary Outcomes (1)

  • Serious adverse events

    0-120 minutes

Study Arms (1)

EZVent

EXPERIMENTAL

* 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

Interventions

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.

Also known as: EZVent Ventilator System
EZVent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Critical Care Unit of Kasr Al-Ainy Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Respiratory InsufficiencyRespiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Yasser Nassar, Prof.Dr

    Kasr El Aini Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Salah, Ph.MSc

CONTACT

+201062256804reg.tcdmena@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Non-randomized, open-labeled, self-control study, single arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

June 1, 2022

Study Start

August 1, 2022

Primary Completion

August 15, 2022

Study Completion

August 30, 2022

Last Updated

June 3, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)