Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children
- Conditions
- Cuff OverinflationCuff Underinflation
- Registration Number
- NCT04413318
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.
- Detailed Description
In this study, the investigators will compare the duration of the period of under-inflation and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous monitoring of tracheal cuff pressure), in critically intubated children. This study aims to determine the effectiveness of the electronic device in the continuous monitoring of tracheal cuff pressure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Infants and children more than 2 days after birth at term and less than 5 years of age
- Patient intubated in the PICU with a cuffed endotracheal tube
- Predicted duration of mechanical ventilation > or = 24-hours
- Signed informed consent
- Intubated with an uncuffed endotracheal tube
- Children admitted to the PICU with a previous tracheostomy
- Preterm children or infants less than 2 days post-term
- Patient under block neuromuscular treatment
- Patient enrolled in another trial that might influence this study results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Percentage of time spend with over or under-inflation of the tracheal cuff 12 hours Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). The period was speared by a time of wash-out of 30 minutes
- Secondary Outcome Measures
Name Time Method The response time to a significant variation in cuff pressure 12 hours Continuous recording of cuff pressure will be performed during the two 12-hours periods (electronic and pneumatic devices). Automated analysis of the response time in milliseconds to a change in cuff pressure of at least 15% above or below the target value
Trial Locations
- Locations (1)
Robert Debré hospital
🇫🇷Paris, France
Robert Debré hospital🇫🇷Paris, France