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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB: 2019-A02246-51 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electronic device followed by pneumatic device | Experimental | 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. |
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| pneumatic device followed by electronic device | Experimental | Children receive the reverse sequence (continuous control using the pneumatic device (Nosten©) for 6-hours followed by the electronic device (VBM©) for 6-hours |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic device (VBM©) | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris LACARRA, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Stephane DAUGER, MD PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Debré hospital | Paris | 75019 | France |
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| Pneumatic device (Nosten©) | Device | Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©). |
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