Ventilator-Associated EventsNCT07212881
Evaluating the Clinical Utility of Modified Ventilator-Associated Event Criteria in Predicting ICU Mortality and Ventilator Duration: Can Less Restrictive Definitions Improve Prediction?
An observational study of Ventilator-Associated Events, run by Benha University at 1 site in Egypt.
Trial summary
Study design: A prospective observational study Study setting: The study will be carried out in the department of critical care medicine, Benha university hospitals. Study time: The study time is set to a period of one year from March 2025 to March 2026. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Associated Events
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study will be conducted on 200 mechanically ventilated patients.
Who may be able to join
- Adult patients (age ≥ 18 years) undergoing mechanical ventilation for ≥ 48 hours.
- Patients admitted to ICU for
- medical
- trauma
- surgical conditions.
Who cannot join
- Age below 18 years.
- extracorporeal life support (ECLS).
- Incomplete or inconsistent daily monitoring data.
- Patients with confirmed or suspected respiratory viral infections (e.g., influenza, COVID-19).
- undergoing palliative care or with a do-not-intubate (DNI) status.
- Pregnant patients due to altered physiological responses.
Show all 10Show fewer
- Patients ventilated for less than 48 hours.
- chronic ventilator dependency prior to ICU admission.
- incomplete medical documentation impacting data collection or outcome analysis.
- severe immunosuppression, such as recent bone marrow or organ transplant recipients, and those on high-dose corticosteroids.
Trial locations and contacts
1 site in 1 country.
About this study
Study design: A prospective observational study
- Study setting: The study will be carried out in the department of critical care medicine, Benha university hospitals.
- Study time: The study time is set to a period of one year from March 2025 to March 2026.
Read the detailed description
Technical design:
- Study design: A prospective observational study
- Study setting: The study will be carried out in the department of critical care medicine, Benha university hospitals.
- Study time: The study time is set to a period of one year from March 2025 to March 2026.
Study population:
The study will be conducted on 200 mechanically ventilated patients.
● Inclusion Criteria Adult patients (age ≥ 18 years) undergoing mechanical ventilation for ≥ 48 hours.
Patients admitted to ICU for medical, trauma, or surgical conditions.
● Exclusion Criteria Age below 18 years.
Patients on extracorporeal life support (ECLS).
Incomplete or inconsistent daily monitoring data.
Patients with confirmed or suspected respiratory viral infections (e.g., influenza, COVID-19).
Patients undergoing palliative care or with a do-not-intubate (DNI) status.
Pregnant patients due to altered physiological responses.
Patients ventilated for less than 48 hours.
Patients with chronic ventilator dependency prior to ICU admission.
Cases with incomplete medical documentation impacting data collection or outcome analysis.
Patients with severe immunosuppression, such as recent bone marrow or organ transplant recipients, and those on high-dose corticosteroids.
Monitoring Parameters
Daily assessment of the following:
Fraction of inspired oxygen (FiO2).
Positive end-expiratory pressure (PEEP).
Record minimum daily values for accurate trend analysis.
VAE Definitions Based on CDC Guidelines (6)
Standard VAE: Sustained increase for ≥2 days in FiO2 ≥ 0.2, or PEEP ≥ 3 cm H2O
● Modified Definitions: VAE24: Increase for 1 day with FiO2 ≥ 0.2 or PEEP ≥ 3 cm H2O.
Light-VAE: sustained increase of the daily minimum value in FiO2 ≥ 2 or PEEP ≥ 2 cmH2O or FiO2 ≥ 0.15 plus PEEP ≥ 1 cmH2O
for two or more days.
Patients management on mechanical ventilator:
VAP Bundle: Key elements of the bundle include elevating the head of the bed to 30-45 degrees to reduce aspiration risk, performing daily assessments for readiness to extubate, and conducting spontaneous awakening and breathing trials to minimize ventilation duration. Proper oral hygiene with chlorhexidine helps maintain oral health and reduce bacterial colonization. Sedation protocols are optimized by using minimal sedation and assessing sedation levels regularly to avoid prolonged ventilation. Additionally, deep vein thrombosis (DVT) prophylaxis and peptic ulcer disease (PUD) prevention are essential components to mitigate secondary complications. (7)
Data Measurements:
- Demographic and Baseline Data Age / Gender / BMI/ APACHE II score/ chronic diseases/ type of patient (medical- surgical - trauma) / reasons for mechanical ventilation
- Mechanical Ventilation Parameters Initial FiO2 and PEEP levels - Duration of mechanical ventilation (in days)
- VAE Monitoring Data Classification of VAE (VAE, VAE24, Light-VAE)
- Outcome Data
ICU mortality - ICU length of stay - Hospital stay- 30 days mortality
- Conditions
- Ventilator-Associated Events
- Keywords
- Ventilator-Associated Events, mechanically ventilated patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-Free Days at Day 28 (VFD-28)
Ventilator-Free Days at Day 28 (VFD-28): The number of days a patient is alive and free from mechanical ventilation within the first 28 days after initiation of mechanical ventilation. Patients who die before day 28 will be assigned a value of zero VFDs.
Measured: at Day 28
* Prolonged Mechanical Ventilation
- Prolonged Mechanical Ventilation (≥7 Days): The proportion of patients requiring mechanical ventilation for 7 days or more.
Measured: for 7 days
Secondary outcomes (6)
Incidence of VAE, VAE24, and Light-VAE: The proportion of patients meeting each definition of VAE.
Incidence of VAE, VAE24, and Light-VAE: The proportion of patients meeting each definition of VAE.
Measured: within 30 days of IC
Duration of Mechanical Ventilation:
The total number of days a patient remains on mechanical ventilation.
Measured: within 30 days of ICU admission.
Length of ICU Stay:
The total number of days a patient spends in the intensive care unit.
Measured: within 30 days of ICU admission.
Length of Hospital Stay:
The total number of days a patient remains hospitalized.
Measured: within 30 days of ICU admission.
ICU Mortality Rate:
The proportion of patients who die during their ICU stay.
Measured: within 30 days of ICU admission.
Day -30 Mortality Rate:
The proportion of patients who die within 30 days of ICU admission.
Measured: within 30 days of ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated EventsStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Hosam Eldin Mohamed Fahmi, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212881
- Sponsor's protocol ID
- mD 3-4-2025
- Status last verified
- Oct 2025
- First submitted
- 24 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Utility of Modified Ventilator-Associated Event Criteria in Predicting ICU Mortality and Ventilator Duration: Can Less Restrictive Definitions Improve Prediction?
- ClinicalTrials.gov ID
- NCT07212881
- Acronym / sponsor ID
- mD 3-4-2025
- Conditions
- Ventilator-Associated Events
- Keywords
- Ventilator-Associated Events, mechanically ventilated patients.
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 8 Oct 2025 (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.
Study design: A prospective observational study
- Study setting: The study will be carried out in the department of critical care medicine, Benha university hospitals.
- Study time: The study time is set to a period of one year from March 2025 to March 2026.
Detailed description
Technical design:
- Study design: A prospective observational study
- Study setting: The study will be carried out in the department of critical care medicine, Benha university hospitals.
- Study time: The study time is set to a period of one year from March 2025 to March 2026.
Study population:
The study will be conducted on 200 mechanically ventilated patients.
● Inclusion Criteria Adult patients (age ≥ 18 years) undergoing mechanical ventilation for ≥ 48 hours.
Patients admitted to ICU for medical, trauma, or surgical conditions.
● Exclusion Criteria Age below 18 years.
Patients on extracorporeal life support (ECLS).
Incomplete or inconsistent daily monitoring data.
Patients with confirmed or suspected respiratory viral infections (e.g., influenza, COVID-19).
Patients undergoing palliative care or with a do-not-intubate (DNI) status.
Pregnant patients due to altered physiological responses.
Patients ventilated for less than 48 hours.
Patients with chronic ventilator dependency prior to ICU admission.
Cases with incomplete medical documentation impacting data collection or outcome analysis.
Patients with severe immunosuppression, such as recent bone marrow or organ transplant recipients, and those on high-dose corticosteroids.
Monitoring Parameters
Daily assessment of the following:
Fraction of inspired oxygen (FiO2).
Positive end-expiratory pressure (PEEP).
Record minimum daily values for accurate trend analysis.
VAE Definitions Based on CDC Guidelines (6)
Standard VAE: Sustained increase for ≥2 days in FiO2 ≥ 0.2, or PEEP ≥ 3 cm H2O
● Modified Definitions: VAE24: Increase for 1 day with FiO2 ≥ 0.2 or PEEP ≥ 3 cm H2O.
Light-VAE: sustained increase of the daily minimum value in FiO2 ≥ 2 or PEEP ≥ 2 cmH2O or FiO2 ≥ 0.15 plus PEEP ≥ 1 cmH2O
for two or more days.
Patients management on mechanical ventilator:
VAP Bundle: Key elements of the bundle include elevating the head of the bed to 30-45 degrees to reduce aspiration risk, performing daily assessments for readiness to extubate, and conducting spontaneous awakening and breathing trials to minimize ventilation duration. Proper oral hygiene with chlorhexidine helps maintain oral health and reduce bacterial colonization. Sedation protocols are optimized by using minimal sedation and assessing sedation levels regularly to avoid prolonged ventilation. Additionally, deep vein thrombosis (DVT) prophylaxis and peptic ulcer disease (PUD) prevention are essential components to mitigate secondary complications. (7)
Data Measurements:
- Demographic and Baseline Data Age / Gender / BMI/ APACHE II score/ chronic diseases/ type of patient (medical- surgical - trauma) / reasons for mechanical ventilation
- Mechanical Ventilation Parameters Initial FiO2 and PEEP levels - Duration of mechanical ventilation (in days)
- VAE Monitoring Data Classification of VAE (VAE, VAE24, Light-VAE)
- Outcome Data
ICU mortality - ICU length of stay - Hospital stay- 30 days mortality
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on 200 mechanically ventilated patients.
Key inclusion criteria (5 listed)
- Adult patients (age ≥ 18 years) undergoing mechanical ventilation for ≥ 48 hours.
- Patients admitted to ICU for
- medical
- trauma
- surgical conditions.
Key exclusion criteria (10 listed)
- Age below 18 years.
- extracorporeal life support (ECLS).
- Incomplete or inconsistent daily monitoring data.
- Patients with confirmed or suspected respiratory viral infections (e.g., influenza, COVID-19).
- undergoing palliative care or with a do-not-intubate (DNI) status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventilator-Free Days at Day 28 (VFD-28)
Time frame: at Day 28
Ventilator-Free Days at Day 28 (VFD-28): The number of days a patient is alive and free from mechanical ventilation within the first 28 days after initiation of mechanical ventilation. Patients who die before day 28 will be assigned a value of zero VFDs.
* Prolonged Mechanical Ventilation
Time frame: for 7 days
* Prolonged Mechanical Ventilation (≥7 Days): The proportion of patients requiring mechanical ventilation for 7 days or more.
6 secondary outcomes
Incidence of VAE, VAE24, and Light-VAE: The proportion of patients meeting each definition of VAE.
Time frame: within 30 days of IC
Duration of Mechanical Ventilation:
Time frame: within 30 days of ICU admission.
Length of ICU Stay:
Time frame: within 30 days of ICU admission.
Length of Hospital Stay:
Time frame: within 30 days of ICU admission.
ICU Mortality Rate:
Time frame: within 30 days of ICU admission.
Day -30 Mortality Rate:
Time frame: within 30 days of ICU admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
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Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Associated Events, run by Benha University 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-Free Days at Day 28 (VFD-28) (time frame: at Day 28). The study lists 2 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 8 Oct 2025.