Impact of Closed Versus Open Endotracheal Suctioning Techniques on the Incidence of Ventilator-Associated Pneumonia in Patients With Severe Traumatic Brain Injury
| Registry | NCT07883083 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 120 (Estimated) |
| Sponsor | Minia University (Other) |
| Conditions | Ventilator-associated Pneumonia, Traumatic Brain Injury |
| Interventions | Closed endotracheal suction system, Open endotracheal suction (Device, procedure) |
| Dates | start 2026-10-04 (estimated), primary completion 2027-04-30 (estimated), completion 2027-05-30 (estimated), first posted 2026-10-20, last updated 2026-10-20 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Ventilator-associated Pneumonia All trials for Traumatic Brain Injury All trials of Closed endotracheal suction system All trials of Open endotracheal suction
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.
Ventilator-associated pneumonia (VAP) is a common and serious complication in mechanically ventilated patients, and patients with severe traumatic brain injury (TBI) are particularly vulnerable. Open suctioning may increase hypoxia and environmental contamination, while closed suctioning may reduce pathogen exposure and help maintain oxygenation, but the evidence remains controversial.
One hundred twenty adult patients with severe TBI (Glasgow Coma Scale \[GCS\] 3-8) will be randomly allocated 1:1 using a computer-generated sequence with sealed opaque envelopes. Both groups receive pre-oxygenation with 100% fraction of inspired oxygen (FiO2) before suctioning and the same standardized VAP prevention measures (head-of-bed elevation, daily sedation interruption, and oral antiseptic care).
VAP will be diagnosed using Centers for Disease Control and Prevention/National Healthcare Safety Network (CDC/NHSN) criteria, supported by the Clinical Pulmonary Infection Score (CPIS) assessed every 48 hours. Endotracheal aspirate cultures are taken at intubation and after 48 hours. The study will be conducted in the intensive care unit (ICU) of Minia University Hospital over about one year.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A (Closed Suction) | Experimental | Device: Closed endotracheal suction system | Endotracheal suctioning using a closed in-line suction system without ventilator disconnection, throughout the duration of mechanical ventilation, with pre-oxygenation with 100% FiO2 for 1-2 minutes before suctioning. |
| Group B (Open Suction) | Active comparator | Procedure: Open endotracheal suction | Endotracheal suctioning using a sterile open technique with ventilator disconnection and sterile disposable catheters, with pre-oxygenation with 100% FiO2 for 1-2 minutes before suctioning. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Minia university hospital | Minya | Egypt |