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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
44
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.
Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).
Robert Debré hospital
Paris, France
Percentage of time spend with over or under-inflation of the tracheal cuff
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
Time frame: 12 hours
The response time to a significant variation in cuff pressure
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
Time frame: 12 hours
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