Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children

Cuff Overinflation Clinical Trial

— CPRATIC-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413318
• Other study ID #: APHP190869
• Secondary ID: IDRCB: 2019-A022
• Status: Completed
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: April 16, 2021

Study information

• Verified date: May 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Cuff Overinflation
• Cuff Underinflation

Intervention

Device:
• Electronic device (VBM©)
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.
• Pneumatic device (Nosten©)
Continuous control using a pneumatic device (Nosten©) for 6-hours followed by 6-hours of continuous control using an electronic device (VBM©).

Locations

Country	Name	City	State
France	Robert Debré hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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