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

May 30, 2015 updated by: Antonio Artigas Raventós, Corporacion Parc Tauli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous control of Pcuff followed by manual control
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.
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.
Other Names:
  • Pressure easy® device (Smiths medical cuff pressure controller)
Active Comparator: Manual control of Pcuff followed by continuous control.
Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 30, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPREI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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