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OpenTrials
Completed

NCT Number: NCT04413318

Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children

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.

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Key information

Conditions

Cuff Overinflation Cuff Underinflation

Age range

2 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Debré hospital

Paris, 75019, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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©).

Primary outcomes

  1. Percentage of time spend with over or under-inflation of the tracheal cuff

    Time frame: 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 outcomes

  1. The response time to a significant variation in cuff pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CPRATIC-2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2020
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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