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OpenTrials
Completed

NCT Number: NCT02109003

Efficiency of a Mechanical Device 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.

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Key information

Conditions

Cuff Overinflation Cuff Underinflation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pressure easy® device

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)

Manual control of Pcuff followed by continuous control.

Device

Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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