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

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ClinicalTrials.gov Identifier: NCT01351259
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : September 4, 2013
Sponsor:
Information provided by (Responsible Party):
Saad NSEIR, University Hospital, Lille

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Mechanical Ventilation Complication Tracheal Intubation Morbidity Device: Pneumatic device, cylindrical or tapered cuff Phase 4

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.

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
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
Study Start Date : February 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: May 10, 2011    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: August 2013

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