Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children (CPRATIC-2)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Cuff Underinflation; Cuff Overinflation

Treatments: Device: Pneumatic device (Nosten©); Device: Electronic device (VBM©)

Study type: Interventional

Funder types: Other

Identifiers

NCT04413318

APHP190869

IDRCB: 2019-A02246-51 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 2 days to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

electronic device followed by pneumatic device

Experimental group

Description:

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.

Treatment:

Device: Electronic device (VBM©)

pneumatic device followed by electronic device

Experimental group

Description:

Children receive the reverse sequence (continuous control using the pneumatic device (Nosten©) for 6-hours followed by the electronic device (VBM©) for 6-hours

Treatment:

Device: Pneumatic device (Nosten©)