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Completed

NCT Number: NCT01351259

Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.

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Key information

Conditions

Mechanical Ventilation Complication Tracheal Intubation Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ICU, Calmette Hospital, CHU de Lille

Lille, Nord, 59037, France

About this study

Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients requiring intubation in the ICU
  • Predicted duration of mechanical ventilation > or = 48h
  • Age > or = 18 years

Exclusion criteria

  • Contraindication for semirecumbent position
  • Contraindication for enteral nutrition
  • Pregnancy

Treatment and study plan

Pneumatic device, cylindrical or tapered cuff

Device

Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff

Other names: Nosten, Kimberly clark, Covidien

Primary outcomes

  1. Percentage of patients with underinflation or overinflation of cuff pressure

    Time frame: 48 h

    Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device)

Secondary outcomes

  1. Impact of tracheal-cuff shape on variations in cuff pressure

    Time frame: 48 h

    Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes.

  2. Impact of continuous control of cuff pressure on microaspiration of gastric contents

    Time frame: 48 h

    Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without the pneumatic device)

  3. Impact of tracheal cuff shape on microaspiration of gastric contents

    Time frame: 48 h

    Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: Nosten

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 10, 2011
Registry last updated
Sep 4, 2013

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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