NCT07834970

Brief Summary

This prospective observational cohort study aims to compare mechanical power between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) in critically ill adult patients receiving invasive mechanical ventilation. Mechanical power will be assessed at different time points during the first 24 hours after intubation, with the primary comparison performed at 24 hours. The study will also evaluate the association between mechanical power and clinical outcomes, including ICU mortality, hospital mortality, successful weaning, duration of mechanical ventilation, and length of ICU and hospital stay.

Trial Health

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Trial Health Score

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

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
37mo left

Started Oct 2026

Typical duration 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

First Submitted

Initial submission to the registry

September 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2029

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 13, 2026

Last Update Submit

September 18, 2026

Conditions

Mechanical PowerAcute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Mechanical power

    Mechanical power will be measured and compared between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) at 24 hours after intubation.

    24 hours after intubation

Secondary Outcomes (3)

  • mechanical power and ICU mortality, hospital mortality, time to death.

    From hospital admission until 30 days after hospital admission.

  • Mechanical power over time

    At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.

  • Successful weaning from mechanical ventilation

    From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)

Study Arms (2)

93 patients in Pressure controlled ventilation

93 patients in Volume controlled ventilation

93 patients in PCV

93 patients in Volume controlled ventilation

Eligibility Criteria

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

Adult patients aged \>18 years with acute respiratory failure requiring invasive mechanical ventilation and admitted to the Respiratory Intensive Care Unit at Assiut University Hospitals will be enrolled. Eligible patients receiving either pressure-controlled ventilation (PCV) or volume-controlled ventilation (VCV) will be prospectively followed during their ICU and hospital stay.

You may qualify if:

  • Adult patients aged \>18 years.
  • Patients with acute respiratory failure who are receiving invasive mechanical ventilation.

You may not qualify if:

  • Patients whose condition requires shifting between VCV and PCV after enrollment.
  • Patients with neurological, neuromuscular, or muscular disorders.
  • Neurological disorders, e.g., stroke, multiple sclerosis, Parkinsonism, and Guillain-Barré syndrome.
  • Neuromuscular junction disorders, e.g., myasthenia gravis.
  • Muscular disorders, e.g., polymyositis and Duchenne muscular dystrophy.
  • Chest wall abnormalities, e.g., kyphoscoliosis, scoliosis, and pectus excavatum.
  • Tracheostomized patients.
  • Patients with raised intra-abdominal pressure (IAP ≥12 mmHg), as estimated by transvesical manometry e.g., massive ascites, bowel obstruction, and postoperative abdominal surgery.
  • Patients with documented chronic type 2 respiratory failure, characterized by an elevated partial pressure of carbon dioxide (PaCO₂ \>45 mmHg), low partial pressure of oxygen (PaO₂), and chronically elevated bicarbonate (HCO₃-) reflecting renal compensation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, Egypt

Location

Related Publications (1)

  • Gattinoni L, Carlesso E, Cadringher P, Valenza F, Vagginelli F, Chiumello D. Physical and biological triggers of ventilator-induced lung injury and its prevention. Eur Respir J Suppl. 2003 Nov;47:15s-25s. doi: 10.1183/09031936.03.00021303.

    PMID: 14621113BACKGROUND

Study Officials

  • Olfat Mostafa El shinawy, Professor

    Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt

    STUDY DIRECTOR

  • Sara Mohamed Hashem, Lecteurer

    Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt

    STUDY DIRECTOR

Central Study Contacts

Sahar Ahmed Okily, Master degree of chest disease

CONTACT

0201094504484sara3hmed2012@gmail.com

Hend Mohamed Sayed, Lecturer

CONTACT

0201098988712Hendmohamed@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 22, 2026

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

October 30, 2029

Last Updated

September 22, 2026

Record last verified: 2026-09

Locations

EG(1)