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

Not Applicable

Completed

• Conditions: Cuff Overinflation; Cuff Underinflation
• Interventions: Device: Pressure easy® device; Device: Manual control of Pcuff followed by continuous control.

• Registration Number: NCT02109003
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-30
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous control of Pcuff followed by manual control	Pressure easy® device	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.
Manual control of Pcuff followed by continuous control.	Manual control of Pcuff followed by continuous control.	Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain