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

Cuff Overinflation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109003
• Other study ID #: EPREI
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: May 30, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Cuff Overinflation
• Cuff Underinflation

Intervention

Device:
• Pressure easy® device
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.
Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.

Locations

Country	Name	City	State
Spain	Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	48 hours	No