Ventilator-associated PneumoniaNCT07883083
Closed Versus Open Endotracheal Suctioning and Ventilator-Associated Pneumonia in Severe Traumatic Brain Injury
A study testing Closed endotracheal suction system and Open endotracheal suction in people with Ventilator-associated Pneumonia and Traumatic Brain Injury, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia, Traumatic Brain Injury
- What is being tested?
- Closed endotracheal suction system and Open endotracheal suction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Minia university hospital
Minya
Mahmoud Ismail, MBBCh, +20 1288512133, nonmezo@gmail.com
About this study
Official title: Impact of Closed Versus Open Endotracheal Suctioning Techniques on the Incidence of Ventilator-Associated Pneumonia in Patients With Severe Traumatic Brain Injury
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.
Read the 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.
- Being tested
- Closed endotracheal suction system, Open endotracheal suction
- Keywords
- Closed Suction, Open Suction, Endotracheal Suctioning, Mechanical Ventilation, Intensive Care Unit
- Medical subject headings
- Pneumonia, Ventilator-Associated, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed endotracheal suction systemDevice
In-line closed suction catheter system that allows endotracheal suctioning without disconnecting the ventilator.
Open endotracheal suctionProcedure or surgery
Endotracheal suctioning using sterile disposable catheters with ventilator disconnection during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Closed Suction) | Experimental | 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. Receives: Device: Closed endotracheal suction system |
| Group B (Open Suction) | Active comparator | 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. Receives: Procedure: Open endotracheal suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 72 hours
Secondary outcomes (4)
PaO2/FiO2 Ratio After Suctioning
Ratio of partial pressure of arterial oxygen (PaO2) to fraction of inspired oxygen (FiO2) measured following suctioning procedures.
Measured: Baseline up to 72 hours
Duration of Mechanical Ventilation
Total duration of mechanical ventilation in days
Measured: Baseline up to 72 hours
Intensive Care Unit (ICU) Length of Stay،
Number of days from intensive care unit (ICU) admission to ICU discharge.
Measured: Baseline up to 72 hours
Intensive Care Unit (ICU) Mortality
Number of patients who die during the ICU stay.
Measured: Baseline up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start4 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Maher Ibrahim Ismail, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883083
- Sponsor's protocol ID
- 2061:7/2026
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Closed Versus Open Endotracheal Suctioning Techniques on the Incidence of Ventilator-Associated Pneumonia in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07883083
- Acronym / sponsor ID
- 2061:7/2026
- Keywords
- Closed Suction, Open Suction, Endotracheal Suctioning, Mechanical Ventilation, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 4 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Closed Suction) | Experimental | Device: 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 comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed endotracheal suction systemIn-line closed suction catheter system that allows endotracheal suctioning without disconnecting the ventilator. | Device | Group A (Closed Suction) |
| Open endotracheal suctionEndotracheal suctioning using sterile disposable catheters with ventilator disconnection during the procedure. | Procedure or surgery | Group B (Open Suction) |
Primary outcome
Incidence Density of Ventilator-Associated Pneumonia
Time frame: 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.
4 secondary outcomes
PaO2/FiO2 Ratio After Suctioning
Time frame: Baseline up to 72 hours
Duration of Mechanical Ventilation
Time frame: Baseline up to 72 hours
Intensive Care Unit (ICU) Length of Stay،
Time frame: Baseline up to 72 hours
Intensive Care Unit (ICU) Mortality
Time frame: Baseline up to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
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Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed endotracheal suction system and Open endotracheal suction in people with Ventilator-associated Pneumonia and Traumatic Brain Injury, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Density of Ventilator-Associated Pneumonia (time frame: Baseline up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.