Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.

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Detailed Description

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The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control 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

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuous control of Pcuff followed by manual control

Patients receive continuous control of cuff pressure with Pressure easy® device for 24h, followed by discontinuous control (every 4 hours) with a manual manometer for 24 h.

Group Type EXPERIMENTAL

Pressure easy® device

Intervention Type DEVICE

Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer.

Manual control of Pcuff followed by continuous control.

Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)

Group Type ACTIVE_COMPARATOR

Manual control of Pcuff followed by continuous control.

Intervention Type DEVICE

Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.

Interventions

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Pressure easy® device

Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer.

Intervention Type DEVICE

Manual control of Pcuff followed by continuous control.

Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.

Intervention Type DEVICE

Other Intervention Names

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Pressure easy® device (Smiths medical cuff pressure controller)

Eligibility Criteria

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Inclusion Criteria

* Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.
* Predicted duration of mechanical ventilation \> or = 48h.
* Age \> or = 18 years.
* Signed informed consent.

Exclusion Criteria

* Anticipated duration of mechanical ventilation\<48h after randomization.
* Tracheostomized patients.
* Patients with contraindication for semirecumbent position.
* Patients participating to another trial that might influence this study results.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No