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

NCT02109003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-06-02

No results posted yet for this study

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.

Conditions

  • Cuff Overinflation
  • Cuff Underinflation

Interventions

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.

DEVICE

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.

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Andrey Rodriguez, MD · Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-07-31
Completion
2014-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02109003 on ClinicalTrials.gov