Closed Versus Open Endotracheal Suctioning and Ventilator-Associated Pneumonia in Severe Traumatic Brain Injury

NCT07883083 · tracked via the Priya Life Science Egypt tracker

Sponsor

Minia University

Phase

Not applicable

Started

2026-10-04

Last updated

2026-10-20

Condition(s) studied

Ventilator-associated PneumoniaTraumatic Brain Injury

Investigational drug(s) / intervention(s)

Closed endotracheal suction systemOpen endotracheal suction

Closed endotracheal suction system: In-line closed suction catheter system that allows endotracheal suctioning without disconnecting the ventilator.

Open endotracheal suction: Endotracheal suctioning using sterile disposable catheters with ventilator disconnection during the procedure.

Study summary

This randomized controlled trial will compare closed versus open endotracheal suctioning techniques for preventing ventilator-associated pneumonia (VAP) in adults with severe traumatic brain injury (TBI) who need mechanical ventilation for more than 48 hours. Patients will be randomly assigned to suctioning with a closed in-line system or with a sterile open technique that disconnects the ventilator. The main outcome is the incidence density of VAP per 1,000 ventilator-days. Other outcomes include oxygenation after suctioning, duration of mechanical ventilation, intensive care unit (ICU) length of stay, and ICU mortality.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years * Isolated head trauma where the primary injury is traumatic brain injury (severe traumatic brain injury (TBI) ,Glasgow Coma Scale (GCS)3-8) * Requirement of endotracheal intubation and mechanical ventilation within 24 hours of admission * Expected duration of mechanical ventilation ≥ 48 hours * First sputum culture taken at intubation must be negative (patients provisionally enrolled; those with a positive first culture are excluded retrospectively) Exclusion Criteria: * Evidence of pneumonia at intubation (new or progressive infiltrate on chest radiograph plus at least two of: fever \>38°C, leukocytosis or leukopenia, purulent tracheal secretions) or a positive first sputum culture * Pre-existing chronic lung disease with active infection * Immunocompromised patients (e.g., chemotherapy, long-term steroids, HIV) * Patients transferred from another ICU after more than 48 hours of ventilation * Early mortality within 48 hours

Primary outcome measure(s)

Incidence Density of Ventilator-Associated Pneumonia — Baseline up to 72 hours
Number of confirmed ventilator-associated pneumonia (VAP) episodes per 1,000 ventilator-days. VAP is diagnosed by a new or progressive infiltrate on chest radiograph plus at least two of: fever \>38°C, leukocytosis or leukopenia, purulent tracheal secretions, with a positive quantitative culture of endotracheal aspirate, supported by a Clinical Pulmonary Infection Score (CPIS) greater than 6.

Trial sites (1)

Facility	City	Region	Status
Minia university hospital	Minya	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07883083 on ClinicalTrials.gov ↗ ← All trials in Egypt