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

NCT07883083 — Not applicable, Not yet recruiting, 120 participants, Minia University

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Impact of Closed Versus Open Endotracheal Suctioning Techniques on the Incidence of Ventilator-Associated Pneumonia in Patients With Severe Traumatic Brain Injury

RegistryNCT07883083
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment120 (Estimated)
SponsorMinia University (Other)
ConditionsVentilator-associated Pneumonia, Traumatic Brain Injury
InterventionsClosed endotracheal suction system, Open endotracheal suction (Device, procedure)
Datesstart 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
Locations1 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

-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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Group A (Closed Suction)ExperimentalDevice: Closed endotracheal suction systemEndotracheal 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 comparatorProcedure: Open endotracheal suctionEndotracheal 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.
  • Closed endotracheal suction system (Device): In-line closed suction catheter system that allows endotracheal suctioning without disconnecting the ventilator.
  • Open endotracheal suction (Procedure): Endotracheal suctioning using sterile disposable catheters with ventilator disconnection during the procedure.

+Outcome measures

Primary outcomes

  • 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.

Secondary outcomes

  • PaO2/FiO2 Ratio After Suctioning [Baseline up to 72 hours]: Ratio of partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FiO2) measured following suctioning procedures.
  • Duration of Mechanical Ventilation [Baseline up to 72 hours]: Total duration of mechanical ventilation in days
  • Intensive Care Unit (ICU) Length of Stay، [Baseline up to 72 hours]: Number of days from intensive care unit (ICU) admission to ICU discharge.
  • Intensive Care Unit (ICU) Mortality [Baseline up to 72 hours]: Number of patients who die during the ICU stay.

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Minia university hospitalMinyaEgypt