Status:
COMPLETED
Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cuff Overinflation
Cuff Underinflation
Eligibility:
All Genders
2-5 years
Phase:
NA
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...
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 trach...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04413318
Start Date
August 12 2020
End Date
April 16 2021
Last Update
October 18 2021
Active Locations (1)
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1
Robert Debré hospital
Paris, France, 75019