Mechanical Ventilation ComplicationNCT07836153
Mechanical Power and Mortality in Mechanically Ventilated Adults
An observational study of Mechanical Ventilation Complication and Ventilator Induced Lung Injury, run by Zagazig University at 1 site in Egypt.
Trial summary
This prospective observational cohort study aims to investigate the relationship between mechanical power during the first 72 hours of invasive mechanical ventilation and 28-day mortality in mechanically ventilated adult patients admitted to the Surgical Intensive Care Unit at Zagazig University Hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Ventilator Induced Lung Injury, ARDS
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2026to 18 Aug 2027
- Phase
- Observational
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: Adult patients requiring invasive mechanical ventilation and admitted to the Surgical Intensive Care Unit at Zagazig University Hospitals.
Who may be able to join
- Age ≥18 years.
- Both sexes.
- Patients requiring invasive controlled mechanical ventilation in the ICU and expected to require mechanical ventilation for at least 72 hours.
- Enrollment within the first 8 hours after initiation of invasive mechanical ventilation.
- Acceptance and written informed consent from a first-degree relative.
Who cannot join
- Predominant spontaneous breathing or weaning modes during the first 48 hours.
- Severe hemodynamic instability precluding standardized measurements.
- Prolonged mechanical ventilation prior to ICU admission.
- Pregnancy.
- Chest trauma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Surgical Intensive Care Unit, Zagazig University Hospitals
Zagazig, Sharqia Province
Zagazig University
About this study
Official title: Relation Between Mechanical Power and Mortality in Mechanically Ventilated Adult Patients
This prospective observational cohort study aims to investigate the relationship between mechanical power during the first 72 hours of invasive mechanical ventilation and 28-day mortality in mechanically ventilated adult patients admitted to the Surgical Intensive Care Unit at Zagazig University Hospitals.
Read the detailed description
This prospective observational cohort study will enroll adult patients admitted to the Surgical Intensive Care Unit who require invasive mechanical ventilation. Mechanical power will be calculated during the first 72 hours of invasive mechanical ventilation using ventilatory parameters recorded during routine clinical care. Patient demographic and clinical characteristics, respiratory and ventilatory parameters, and relevant laboratory data will be recorded. Patients will be followed during their ICU stay, and 28-day mortality will be assessed as the primary outcome. The association between mechanical power and 28-day mortality will be evaluated using appropriate statistical analyses, including receiver operating characteristic (ROC) curve analysis to assess the predictive performance of mechanical power.
- Conditions
- Mechanical Ventilation Complication, Ventilator Induced Lung Injury, ARDS, ICU Mortality (Survival Rate)
- Keywords
- Mechanical ventilation, Driving Pressure, 28-Day Mortality, Critically Ill Patients
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically Ventilated Adult Patients | Adult patients requiring invasive mechanical ventilation and admitted to the Surgical Intensive Care Unit at Zagazig University Hospitals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day Mortality
All-cause mortality within 28 days after initiation of invasive mechanical ventilation.
Measured: At 28 days after initiation of invasive mechanical ventilation
Secondary outcomes (3)
Driving Pressure and Plateau Pressure
Correlation between mechanical power and driving pressure and plateau pressure at 24, 48, and 72 hours.
Measured: At 24, 48, and 72 hours after initiation of invasive mechanical ventilation
Ventilator-Free Days
Number of ventilator-free days within the first 28 days.
Measured: Through 28 days after initiation of invasive mechanical ventilation
ICU Length of Stay
Duration of stay in the intensive care unit
Measured: From ICU admission until ICU discharge or death, through 28 days after initiation of invasive mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion25 May 2027 (estimated)
- Study completion18 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ghada M Abd Elrazik, Prof of anesthesia and Icu, Study chair, Zagazig UniversityAsmaa M Galal Eldin, Assistant prof anesthesia,Icu, Study chair, Zagazig UniversityAhmed A Ibrahim, Lecturer of anesthesia, Icu, Study chair, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836153
- Sponsor's protocol ID
- ZU-MP-MORTALITY-2026
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No