Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children

Not Applicable

Completed

• Conditions: Cuff Overinflation; Cuff Underinflation
• Interventions: Device: Pneumatic device (Nosten©); Device: Electronic device (VBM©)

• Registration Number: NCT04413318
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Study Start: 2020-08-12
• Primary Completion: 2021-04-16
• Study Completion: 2021-04-16
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pneumatic device followed by electronic device	Pneumatic device (Nosten©)	Children receive the reverse sequence (continuous control using the pneumatic device (Nosten©) for 6-hours followed by the electronic device (VBM©) for 6-hours
electronic device followed by pneumatic device	Electronic device (VBM©)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Robert Debré hospital; 🇫🇷 Paris, France