Comparing automatic and manual monitoring of endotracheal tube cuff pressure in children
Comparison of Automatic and Manual Endotracheal Tube Cuff Pressure Monitoring in Pediatric Intensive Care Patients: A Randomized Controlled Cross-Over Study
This study is testing whether using an automatic system to monitor the pressure of breathing tubes in children on ventilators works better and is easier for nurses than doing it by hand.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Dr. Behcet Uz Children's Hospital Academic / other |
| Locations | 4 sites (Aydın and 3 other locations) |
| Trial ID | NCT06965400 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of automatic cuff pressure monitoring using the IntelliCuff® system versus manual monitoring in pediatric intensive care patients requiring mechanical ventilation. It is a prospective, randomized controlled cross-over study involving patients aged 1 month to 18 years who are intubated and expected to need invasive ventilation for at least 48 hours. Each patient undergoes two 24-hour monitoring periods, one with automatic and one with manual monitoring, to assess cuff pressure deviations and nursing workload. The goal is to determine if automatic monitoring improves cuff pressure control and reduces complications.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1 month to 18 years requiring invasive mechanical ventilation for at least 48 hours.
Not a fit: Patients with tracheostomy, known tracheal pathology, or those who are extubated within 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cuff pressure management, reducing complications and nursing workload in pediatric intensive care.
How similar studies have performed: While the approach of automatic cuff pressure monitoring is gaining interest, this specific comparison has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged between 1 month and 18 years who were intubated with a cuffed endotracheal tube and expected to require invasive mechanical ventilation for at least 48 hours were eligible for inclusion Exclusion Criteria: * Patients with tracheostomy, known tracheal pathology, extubated within 48 hours, or those requiring frequent ventilator adjustments due to clinical instability were excluded.
Where this trial is running
Aydın and 3 other locations
- Aydin Obstetric and pediatrics Hospital — Aydın, Turkey (Recruiting)
- Cam Sakura Research and Training Hospital — Istanbul, Turkey (Recruiting)
- Acibadem University, Acibadem Altunizade Hospital — Istanbul, Turkey (Recruiting)
- The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital — İzmir, Turkey (Recruiting)
Study contacts
- Study coordinator: Hasan Agin, Prof.Dr.
- Email: Hasanagin@gmail.com
- Phone: +905362013162
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.