Cuff Overinflation, Cuff Underinflation
Conditions
Keywords
tracheal cuff pressure, pediatric critical care
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.
Interventions
DEVICEElectronic device (VBM©)
Continuous control of tracheal cuff pressure using an electronic device (VBM©) for 6-hours followed by continuous control using a pneumatic device (Nosten©) for 6-hours.
DEVICEPneumatic device (Nosten©)
Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Days to 5 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed