Comparison of Two Strategies for Endotracheal Tube Cuff Underinflation Prevention During Invasive Mechanical Ventilation

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-07-31

Brief Summary

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During invasive mechanical ventilation, maintaining endotracheal tube cuff pressure (Pcuff) around 25 cmH2O is recommended for sealing the upper airways. The continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control.

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Detailed Description

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During invasive mechanical ventilation, maintaining a tracheal cuff pressure (Pcuff) around 25 cmH2O is recommended to prevent cuff over- (\> 30 cmH2O) and underinflation (\< 20 cmH2O), identified as risk factors for tracheal ischemic damage and for oropharyngeal microaspirations, respectively. Intermittent measurements with intermittent adjustments of Pcuff is the widely used strategy but, between measurements, over- and underinflation episodes could occur. Devices allowing a continuous control of Pcuff are therefore appealing. As microaspiration is the most relevant mechanism for ventilator-associated pneumonia (VAP), the use of such devices may decrease the incidence of VAP for instance. To the knowledge of the investigators, the continuous control of Pcuff with a simple mechanical device, the Tracoe Smart CuffmanagerTM, has never been assessed. The investigators hypothesize that the Tracoe Smart CuffmanagerTM would allow a reduction of the incidence of underinflation episodes, as compared with the intermittent strategy of Pcuff control. As secondary objectives, the investigators aim to assess the impact of the use of the Tracoe Smart CuffmanagerTM on the incidence of overinflation episodes and on the incidence of early ventilator-associated pneumonia. A homogenous population will be studied for this purpose: patients admitted with severe acute brain damage.

Conditions

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Acute Brain Injury Brain Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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continuous adjustment strategy

patients assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff

Group Type EXPERIMENTAL

Tracoe Smart CuffmanagerTM

Intervention Type DEVICE

In patients randomly assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff. Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments

usual care

patients with usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tracoe Smart CuffmanagerTM

In patients randomly assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff. Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* with severe acute brain damage
* admitted in the ICU for less than 48 hours
* and expected to receive invasive mechanical ventilation (through orotracheal tube with a low pressure-high volume cuff) for at least 48 hours after inclusion.

Exclusion Criteria

* change in the upper airway management within the 48 hours following the inclusion (extubation or change in the tracheal tube or tracheostomy)
* pregnancy, moribund status.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No