Respiratory FailureNCT05399017
Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients
A study testing EZVent in people with Respiratory Failure and Respiratory Disease, run by Triclinium Clinical Development Middle East and North Africa at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Respiratory Disease
- What is being tested?
- EZVent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Critical Care Unit of Kasr Al-Ainy Hospital
Cairo
Yasser Nassar, Prof.Dr
About this study
Official title: Open-labeled, Non-randomized, Self-controlled Study to Evaluate the Safety and Performance of EZVent in Hospitalized Mechanically Ventilated Patients
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.
Read more
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
- Being tested
- EZVent
- Keywords
- EZVent, Ventilator, Mechanical Ventilator, Respiratory failure, medical device, ventilator performance, Egyptian ventilator, ventilator clinical evaluation, ventilator clinical investigation, EZVent clinical evaluation
- Medical subject headings
- Respiratory Insufficiency, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZVentDevice
Also called EZVent Ventilator System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: EZVent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0-120 minutes
Secondary outcomes (1)
Serious adverse events
Serious adverse events (cardiac arrest, pneumothorax, Cardiac tamponade or any other serious medical event)
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, open-labeled, self-control study, single arm.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Triclinium Clinical Development Middle East and North Africa
- Sponsor type
- University, hospital or other
- Collaborators
- ezz medical Industries
- Responsible party
- Sponsor
- Investigators
- Yasser Nassar, Prof.Dr, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399017
- Sponsor's protocol ID
- MD-004
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labeled, Non-randomized, Self-controlled Study to Evaluate the Safety and Performance of EZVent in Hospitalized Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT05399017
- Acronym / sponsor ID
- MD-004
- Conditions
- Respiratory Failure, Respiratory Disease
- Keywords
- EZVent, Ventilator, Mechanical Ventilator, Respiratory failure, medical device, ventilator performance, Egyptian ventilator, ventilator clinical evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Triclinium Clinical Development Middle East and North AfricaUniversity, hospital or other
- Collaborators
- ezz medical Industries
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, open-labeled, self-control study, single arm.
| Arm | Type | Receives |
|---|---|---|
| EZVent | Experimental | Device: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EZVentAlso: EZVent Ventilator SystemEZVent 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. | Device | EZVent |
Primary outcome
Comparable gas exchange parameters
Time frame: 0-120 minutes
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
Time frame: 0-120 minutes
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
Time frame: 0-120 minutes
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
Time frame: 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)
Comparable hemodynamic and vital parameters
Time frame: 0-120 minutes
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
Time frame: 0-120 minutes
Comparable hemodynamic and vital parameters (pulse) at T2 when the patient is on EZVent in relation to at T0
Comparable hemodynamic and vital parameters
Time frame: 0-120 minutes
Comparable hemodynamic and vital parameters (Temperature) at T2 when the patient is on EZVent in relation to at T0
Comparable hemodynamic and vital parameters
Time frame: 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
Time frame: 0-120 minutes
Comparable lung mechanics parameters (Static Compliance) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Time frame: 0-120 minutes
Comparable lung mechanics parameters (Airway resistance) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Time frame: 0-120 minutes
Comparable lung mechanics parameters (Tidal volume) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Time frame: 0-120 minutes
Comparable lung mechanics parameters (Mean Airway Pressure) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Time frame: 0-120 minutes
Comparable lung mechanics parameters (Plateau) at T2 when patient was on EZVent in relation to readings at T0
Comparable lung mechanics parameters
Time frame: 0-120 minutes
Comparable lung mechanics parameters (Peak) at T2 when patient was on EZVent in relation to readings at T0
1 secondary outcome
Serious adverse events
Time frame: 0-120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Nassar, Prof.Dr principal investigator
Kasr El Aini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EZVent in people with Respiratory Failure and Respiratory Disease, run by Triclinium Clinical Development Middle East and North Africa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Salah, Ph.MSc (+201062256804, reg.tcdmena@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparable gas exchange parameters (time frame: 0-120 minutes). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.