NCT07836153

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Sep 2026Aug 2027

First Submitted

Initial submission to the registry

September 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2027

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 9, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

Mechanical ventilationDriving Pressure28-Day MortalityCritically Ill Patients

Outcome Measures

Primary Outcomes (1)

  • 28-Day Mortality

    All-cause mortality within 28 days after initiation of invasive mechanical ventilation.

    At 28 days after initiation of invasive mechanical ventilation

Secondary Outcomes (3)

  • Driving Pressure and Plateau Pressure

    At 24, 48, and 72 hours after initiation of invasive mechanical ventilation

  • Ventilator-Free Days

    Through 28 days after initiation of invasive mechanical ventilation

  • ICU Length of Stay

    From ICU admission until ICU discharge or death, through 28 days after initiation of invasive mechanical ventilation

Study Arms (1)

Mechanically Ventilated Adult Patients

Adult patients requiring invasive mechanical ventilation and admitted to the Surgical Intensive Care Unit at Zagazig University Hospitals.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients requiring invasive mechanical ventilation and admitted to the Surgical Intensive Care Unit at Zagazig University Hospitals.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Intensive Care Unit, Zagazig University Hospitals

Zagazig, Sharqia Province, Egypt

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ghada M Abd Elrazik, Prof of anesthesia and Icu

    Zagazig University

    STUDY CHAIR
  • Asmaa M Galal Eldin, Assistant prof anesthesia,Icu

    Zagazig University

    STUDY CHAIR
  • Ahmed A Ibrahim, Lecturer of anesthesia, Icu

    Zagazig University

    STUDY CHAIR

Central Study Contacts

Tasneem Y Elshawadfy

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 23, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

May 25, 2027

Study Completion (Estimated)

August 18, 2027

Last Updated

September 23, 2026

Record last verified: 2026-09

Locations