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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02109003
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Antonio Artigas Raventós, Corporacion Parc Tauli

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cuff Overinflation Cuff Underinflation Device: Pressure easy® device Device: Manual control of Pcuff followed by continuous control. Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014
Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109003


Locations
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Spain
Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Andrey Rodriguez, MD Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Antonio Artigas Raventós, Director of Critical Care Unit, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02109003    
Other Study ID Numbers: EPREI
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015
Keywords provided by Antonio Artigas Raventós, Corporacion Parc Tauli:
tracheal cuff
cuff overinflation
cuff underinflation
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes