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Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children

NCT ID: NCT04413318

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2021-04-16

Brief Summary

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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

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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.

Conditions

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Cuff Overinflation Cuff Underinflation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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electronic device followed by pneumatic device

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.

Group Type EXPERIMENTAL

Electronic device (VBM©)

Intervention Type 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 followed by electronic device

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

Group Type EXPERIMENTAL

Pneumatic device (Nosten©)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

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©).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Days

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris LACARRA, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Stephane DAUGER, MD PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Robert Debré hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IDRCB: 2019-A02246-51

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190869

Identifier Type: -

Identifier Source: org_study_id