Comparing methods to prevent pneumonia in intubated children
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; A Randomized Controlled Study
This study is testing whether using automatic or manual control of breathing tube pressure can help prevent pneumonia in children who need to be on a ventilator.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 168 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Istanbul Medeniyet University Academic / other |
| Locations | 1 site (Istanbul, Kadikoy) |
| Trial ID | NCT05918172 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of automatic versus manual control of endotracheal cuff pressure in preventing ventilator-associated pneumonia (VIP) in pediatric patients. It hypothesizes that maintaining optimal cuff pressure will reduce the incidence of VIP, which is a significant cause of morbidity in intensive care. The study will include patients aged 1 month to 18 years who require mechanical ventilation for at least 48 hours, and will utilize a randomized controlled design to assign participants to either the automatic or manual cuff pressure measurement group. The outcomes will be assessed to determine which method is more effective in preventing VIP.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1 month to 18 years requiring mechanical ventilation for at least 48 hours.
Not a fit: Patients with recent intubation history, airway trauma, or those with immunosuppression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for ventilator-associated pneumonia in pediatric intensive care patients.
How similar studies have performed: While there are few adult studies on this topic, this is the first randomized controlled study focusing on pediatric patients, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:Pediatric patients aged 1 month to 18 years who required at least 48 hours of mechanical ventilation were included in the study before the 24th hour of intubation and mechanical ventilation - Exclusion Criteria:history of intubation in the last 14 days, tracheomalacia secondary to trauma, stridor, suspected tracheal stenosis, refusal to participate in the study, presence of tracheotomy, mechanical ventilation for less than 48 hours, mechanical ventilation for more than 24 hours at PICU admission , suspected or diagnosed immunodeficiency, history of malignant disease (active or in remission), chronic pulmonary and/or heart disease, chronic other systemic diseases, and use of immunosuppressive medication (such as corticosteroids). -
Where this trial is running
Istanbul, Kadikoy
- IstanbulMU — Istanbul, Kadikoy, Turkey (Recruiting)
Study contacts
- Study coordinator: Ayşe Asik
- Email: drayseasik@gmail.com
- Phone: 05533280449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.