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

NCT06965400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Cuff Pressure
  • Mechanical Ventilation
  • Pediatric Intensive Care

Interventions

DEVICE

Automatic Cuff Pressure Control

he IntelliCuff® system (Hamilton Medical, Switzerland) continuously monitored and automatically adjusted cuff pressure to keep it within the target range of 15-25 cmH₂O. Manual intervention was only required upon system alert.

Sponsors & Collaborators

  • Hamilton Medical AG

    collaborator INDUSTRY

  • Dr. Behcet Uz Children's Hospital

    lead OTHER

Principal Investigators

  • Hasan Agin, Prof.Dr. · Dr. Behcet Uz Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2025-08-01
Completion
2025-08-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965400 on ClinicalTrials.gov