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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Saad NSEIR, University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01351259
First received: May 9, 2011
Last updated: August 31, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University Hospital, Lille:

Primary Outcome Measures:
  • Percentage of patients with underinflation or overinflation of cuff pressure [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 9, 2011
Last Updated: August 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 19, 2014