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
- 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: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Mechanical Power and Mortality in Mechanically Ventilated Adult Patients
- ClinicalTrials.gov ID
- NCT07836153
- Acronym / sponsor ID
- ZU-MP-MORTALITY-2026
- Conditions
- Mechanical Ventilation Complication, Ventilator Induced Lung Injury, ARDS, ICU Mortality (Survival Rate)
- Keywords
- Mechanical ventilation, Driving Pressure, 28-Day Mortality, Critically Ill Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 18 Aug 2027 (estimated)
- First posted
- 23 Sep 2026 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated Adult Patients | – | –Adult patients requiring invasive mechanical ventilation and admitted to the Surgical Intensive Care Unit at Zagazig University Hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients requiring invasive mechanical ventilation and admitted to the Surgical Intensive Care Unit at Zagazig University Hospitals.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
28-Day Mortality
Time frame: At 28 days after initiation of invasive mechanical ventilation
All-cause mortality within 28 days after initiation of invasive mechanical ventilation.
3 secondary outcomes
Driving Pressure and Plateau Pressure
Time frame: At 24, 48, and 72 hours after initiation of invasive mechanical ventilation
Ventilator-Free Days
Time frame: Through 28 days after initiation of invasive mechanical ventilation
ICU Length of Stay
Time frame: From ICU admission until ICU discharge or death, through 28 days after initiation of invasive mechanical ventilation
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 23 Sep 2026.
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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.
Ghada M Abd Elrazik, Prof of anesthesia and Icu study chair
Zagazig University
Asmaa M Galal Eldin, Assistant prof anesthesia,Icu study chair
Zagazig University
Ahmed A Ibrahim, Lecturer of anesthesia, Icu study chair
Zagazig University
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 Mechanical Ventilation Complication and Ventilator Induced Lung Injury, run by Zagazig 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 5 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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?
Contact Tasneem Y Elshawadfy (201097684895, Tasneemelserafy206@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day Mortality (time frame: At 28 days after initiation of invasive mechanical ventilation). 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 23 Sep 2026.