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

Corporacion Parc Tauli18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cuff Overinflation Cuff Underinflation

Interventions

Pressure easy® deviceDEVICE

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.DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí

Sabadell, Barcelona, Spain

Outcomes

Primary Outcomes

Percentage of recording time spent with cuff overinflation or underinflation

Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device)

Time frame: 48 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.