CompletedNot Applicable

Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care

Turkey (Türkiye)241 participantsStarted 2023-06-01

Plain-language summary

This study was designed to compare manual (intermittent) versus automatic (continuous) endotracheal cuff pressure monitoring for the prevention of ventilator-associated pneumonia (VAP) in mechanically ventilated pediatric intensive care patients. The study was based on the hypothesis that maintaining endotracheal cuff pressure within the optimal range may reduce the incidence of VAP.

Who can participate

Age range

1 Month – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 1 month to 18 years * Intubated and mechanically ventilated patients expected to require at least 48 hours of mechanical ventilation * Eligibility assessed and enrollment completed within 24 hours of intubation and initiation of mechanical ventilation Exclusion Criteria: * Previous intubation within 14 days before enrollment * Already receiving mechanical ventilation for more than 24 hours at the time of PICU admission or screening * Expected duration of mechanical ventilation less than 48 hours * Presence of tracheostomy * Trauma-related tracheomalacia * Stridor * Suspected or confirmed tracheal stenosis * Suspected or confirmed immunodeficiency * Current or previous malignancy * Chronic pulmonary, cardiac, or other systemic disease * Current use of immunosuppressive medications, including corticosteroids * Declined consent / refusal to participate

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of VIP incidences

Timeframe: january 2022 - january 2024

Trial details

NCT IDNCT05918172

SponsorIstanbul Medeniyet University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Ventilator-associated Pneumonia trials