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Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

Primary Purpose

Respiratory Failure, Respiratory Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
EZVent
Sponsored by
Triclinium Clinical Development Middle East and North Africa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Failure focused on measuring EZVent, Ventilator, Mechanical Ventilator, Respiratory failure, medical device, ventilator performance, Egyptian ventilator, ventilator clinical evaluation, ventilator clinical investigation, EZVent clinical evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Critical Care Unit of Kasr Al-Ainy Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EZVent

Arm Description

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).

Outcomes

Primary Outcome Measures

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).
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)
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)
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)
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
Comparable hemodynamic and vital parameters
Comparable hemodynamic and vital parameters (pulse) at T2 when the patient is on EZVent in relation to at T0
Comparable hemodynamic and vital parameters
Comparable hemodynamic and vital parameters (Temperature) at T2 when the patient is on EZVent in relation to at T0
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
Comparable lung mechanics parameters
Comparable lung mechanics parameters (Static Compliance) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Comparable lung mechanics parameters (Airway resistance) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Comparable lung mechanics parameters (Tidal volume) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Comparable lung mechanics parameters (Mean Airway Pressure) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Comparable lung mechanics parameters (Plateau) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Comparable lung mechanics parameters (Peak) at T2 when patient was on EZVent in relation to readings at T0

Secondary Outcome Measures

Serious adverse events
Serious adverse events (cardiac arrest, pneumothorax, Cardiac tamponade or any other serious medical event)

Full Information

First Posted
May 24, 2022
Last Updated
June 2, 2022
Sponsor
Triclinium Clinical Development Middle East and North Africa
Collaborators
ezz medical Industries
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1. Study Identification

Unique Protocol Identification Number
NCT05399017
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Triclinium Clinical Development Middle East and North Africa
Collaborators
ezz medical Industries

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized, open-labeled, self-control study, single arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EZVent
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
EZVent
Other Intervention Name(s)
EZVent Ventilator System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparable gas exchange parameters
Description
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
Title
Comparable gas exchange parameters
Description
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
Title
Comparable gas exchange parameters
Description
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
Title
Comparable gas exchange parameters
Description
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
Title
Comparable hemodynamic and vital parameters
Description
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
Title
Comparable hemodynamic and vital parameters
Description
Comparable hemodynamic and vital parameters (pulse) at T2 when the patient is on EZVent in relation to at T0
Time Frame
0-120 minutes
Title
Comparable hemodynamic and vital parameters
Description
Comparable hemodynamic and vital parameters (Temperature) at T2 when the patient is on EZVent in relation to at T0
Time Frame
0-120 minutes
Title
Comparable hemodynamic and vital parameters
Description
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
Title
Comparable lung mechanics parameters
Description
Comparable lung mechanics parameters (Static Compliance) at T2 when patient was on EZVent in relation to readings at T0
Time Frame
0-120 minutes
Title
Comparable lung mechanics parameters
Description
Comparable lung mechanics parameters (Airway resistance) at T2 when patient was on EZVent in relation to readings at T0
Time Frame
0-120 minutes
Title
Comparable lung mechanics parameters
Description
Comparable lung mechanics parameters (Tidal volume) at T2 when patient was on EZVent in relation to readings at T0
Time Frame
0-120 minutes
Title
Comparable lung mechanics parameters
Description
Comparable lung mechanics parameters (Mean Airway Pressure) at T2 when patient was on EZVent in relation to readings at T0
Time Frame
0-120 minutes
Title
Comparable lung mechanics parameters
Description
Comparable lung mechanics parameters (Plateau) at T2 when patient was on EZVent in relation to readings at T0
Time Frame
0-120 minutes
Title
Comparable lung mechanics parameters
Description
Comparable lung mechanics parameters (Peak) at T2 when patient was on EZVent in relation to readings at T0
Time Frame
0-120 minutes
Secondary Outcome Measure Information:
Title
Serious adverse events
Description
Serious adverse events (cardiac arrest, pneumothorax, Cardiac tamponade or any other serious medical event)
Time Frame
0-120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Salah, Ph.MSc
Phone
+201062256804
Email
reg.tcdmena@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Nassar, Prof.Dr
Organizational Affiliation
Kasr El Aini Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Critical Care Unit of Kasr Al-Ainy Hospital
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasser Nassar, Prof.Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients

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