Continuous Control of Tracheal Cuff Pressure and Microaspiration in 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

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

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Detailed Description

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Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.

In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Conditions

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continuous control

Continuous control of cuff pressure using a pneumatic device

Group Type EXPERIMENTAL

Continuous control of cuff pressure

Intervention Type DEVICE

Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)

Manual control

Manual control of cuff pressure is a routine practice in ICU patients

Group Type ACTIVE_COMPARATOR

Manual control of cuff pressure

Intervention Type DEVICE

Manual control of cuff pressure is a routine practice in ICU patients

Interventions

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Continuous control of cuff pressure

Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)

Intervention Type DEVICE

Manual control of cuff pressure

Manual control of cuff pressure is a routine practice in ICU patients

Intervention Type DEVICE

Other Intervention Names

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Automatic control of cuff pressure (Rusch, Kernen, Germany) Manual manometer

Eligibility Criteria

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Inclusion Criteria

* age \> or = 18 years
* tracheal intubation using a polyvinylchloride tube
* predictible duration of mechanical ventilation \> 48 h
* enteral nutrition