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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351259
First Posted: May 10, 2011
Last Update Posted: September 4, 2013
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.
Information provided by (Responsible Party):
Saad NSEIR, University Hospital, Lille
  Purpose
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.

Condition Intervention Phase
Mechanical Ventilation Complication Tracheal Intubation Morbidity Device: Pneumatic device, cylindrical or tapered cuff Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

Further study details as provided by Saad NSEIR, University Hospital, Lille:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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)

  • 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


Enrollment: 64
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pneumatic device, tapered cuff
Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff
Device: Pneumatic device, cylindrical or tapered cuff
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
Experimental: Pneumatic device, cylindrical cuff
Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes
Device: Pneumatic device, cylindrical or tapered cuff
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
Active Comparator: Routine care, tapered cuff
Routine care of cuff pressure using a manometer, tapered polyurethane cuff
Device: Pneumatic device, cylindrical or tapered cuff
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
Active Comparator: Routine care, cylindrical cuff
Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff
Device: Pneumatic device, cylindrical or tapered cuff
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT01351259


Locations
France
ICU, Calmette Hospital, CHU de Lille
Lille, Nord, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Saad NSEIR, MD CHU de Lille
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saad NSEIR, Dr, University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01351259     History of Changes
Other Study ID Numbers: 2009-A00598-49
2009_20/0925 ( Other Identifier: sponsor )
First Submitted: May 9, 2011
First Posted: May 10, 2011
Last Update Posted: September 4, 2013
Last Verified: August 2013

Keywords provided by Saad NSEIR, University Hospital, Lille:
Mechanical ventilation
Intubation
Cuff pressure
Microaspiration