Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children

Study Overview
=================
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.

Official Title
-----------------
A Cross-over Study to Compare Two Different Tracheal Cuff Pressure Monitoring Devices in a Pediatric Intensive Care Unit

Conditions
-----------------
Cuff Overinflation, Cuff Underinflation

Intervention / Treatment
-----------------
* Device: Electronic device (VBM©)
* Device: Pneumatic device (Nosten©)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electronic device followed by pneumatic device<br>Children receive continuous control of tracheal cuff pressure with the electronic device (VBM©) for 6-hours followed by continuous control of tracheal cuff pressure with the pneumatic device (Nosten©) for 6-hours. | Device: Electronic device (VBM©)<br>* 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.<br>|
| Experimental: pneumatic device followed by electronic device<br>Children receive the reverse sequence (continuous control using the pneumatic device (Nosten©) for 6-hours followed by the electronic device (VBM©) for 6-hours | Device: Pneumatic device (Nosten©)<br>* Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tracheal cuff pressure, pediatric critical care