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

Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02109003

Enrollment

Registered

2014-04-09

Start date

2014-04-30

Completion date

2014-12-31

Last updated

2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cuff Overinflation, Cuff Underinflation

Keywords

tracheal cuff, cuff overinflation, cuff underinflation

Brief summary

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.

Detailed 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.

Interventions

DEVICEManual 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.

DEVICEPressure easy® device

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of recording time spent with cuff overinflation or underinflation	48 hours	Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026