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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.
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  • 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.

Egypt1 site
  • Benha university

    Banhā

Other trials in Egypt

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:

  1. Demographic and Baseline Data Age / Gender / BMI/ APACHE II score/ chronic diseases/ type of patient (medical- surgical - trauma) / reasons for mechanical ventilation
  2. Mechanical Ventilation Parameters Initial FiO2 and PEEP levels - Duration of mechanical ventilation (in days)
  3. VAE Monitoring Data Classification of VAE (VAE, VAE24, Light-VAE)
  4. Outcome Data

ICU mortality - ICU length of stay - Hospital stay- 30 days mortality

Keywords
Ventilator-Associated Events, mechanically ventilated patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. * 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)
  1. 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

  2. Duration of Mechanical Ventilation:

    The total number of days a patient remains on mechanical ventilation.

    Measured: within 30 days of ICU admission.

  3. Length of ICU Stay:

    The total number of days a patient spends in the intensive care unit.

    Measured: within 30 days of ICU admission.

  4. Length of Hospital Stay:

    The total number of days a patient remains hospitalized.

    Measured: within 30 days of ICU admission.

  5. ICU Mortality Rate:

    The proportion of patients who die during their ICU stay.

    Measured: within 30 days of ICU admission.

  6. 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.

  1. First posted8 Oct 2025
  2. Study start1 Mar 2025
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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)
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

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.

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