An interventional study of Closed endotracheal suction system and Open endotracheal suction in Ventilator-associated Pneumonia and Traumatic Brain Injury, sponsored by Minia University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Minia University · Not applicable, Interventional, and Prevention
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.
405 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 264 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Minia University is the lead sponsor of 368 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Closed endotracheal suction system
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.
Procedure: Open endotracheal suction
In-line closed suction catheter system that allows endotracheal suctioning without disconnecting the ventilator.
Endotracheal suctioning using sterile disposable catheters with ventilator disconnection during the procedure.
Incidence Density of Ventilator-Associated Pneumonia
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.
Time frame: Baseline up to 72 hours
PaO2/FiO2 Ratio After Suctioning
Ratio of partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FiO2) measured following suctioning procedures.
Time frame: Baseline up to 72 hours
Duration of Mechanical Ventilation
Total duration of mechanical ventilation in days
Time frame: Baseline up to 72 hours
Intensive Care Unit (ICU) Length of Stay،
Number of days from intensive care unit (ICU) admission to ICU discharge.
Time frame: Baseline up to 72 hours
Intensive Care Unit (ICU) Mortality
Number of patients who die during the ICU stay.
Time frame: Baseline up to 72 hours
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pneumonia, Ventilator-Associated →