CompletedNot Applicable

Comparison of Automatic and Manual Endotracheal Tube Cuff Pressure Monitoring in Pediatric Intensive Care Patients

Turkey (Türkiye)32 participantsStarted 2025-05-02

Plain-language summary

This prospective, randomized controlled cross-over study compares automatic (IntelliCuff®) and manual methods of endotracheal tube cuff pressure (CP) monitoring in pediatric intensive care patients. The study evaluates the frequency and duration of cuff pressure deviations outside the recommended range (15-25 cmH₂O) and assesses the impact on nursing workload.

Who can participate

Age range1 Month – 18 Years

SexALL

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

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.

What they're measuring

Total Time Spent Under Low Cuff Pressure

Timeframe: 24 hours per intervention phase

Total Time Spent Under High Cuff Pressure

Timeframe: 24 hours per intervention phase

Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required Number of Manual Corrections Required

Timeframe: 24 hours per intervention phase

Trial details

NCT IDNCT06965400

SponsorDr. Behcet Uz Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Cuff Pressure trials