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

Corporacion Parc Tauli

Status: Completed

Conditions: Cuff Underinflation; Cuff Overinflation

Treatments: Device: Pressure easy® device; Device: Manual control of Pcuff followed by continuous control.

Study type: Interventional

Funder types: Other

Identifiers

NCT02109003

EPREI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Continuous control of Pcuff followed by manual control

Experimental group

Description:

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.

Treatment:

Device: Pressure easy® device

Manual control of Pcuff followed by continuous control.

Active Comparator group

Description:

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

Treatment:

Device: Manual control of Pcuff followed by continuous control.