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

August 31, 2013 updated by: Saad NSEIR, University Hospital, Lille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord
      • Lille, Nord, France, 59037
        • ICU, Calmette Hospital, CHU de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Covidien
  • Nosten
  • Kimberly clark
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:
  • Covidien
  • Nosten
  • Kimberly clark
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:
  • Covidien
  • Nosten
  • Kimberly clark
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:
  • Covidien
  • Nosten
  • Kimberly clark

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
48 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 h
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)
48 h
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
48 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Saad NSEIR, MD, CHU de Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

August 31, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009-A00598-49
  • 2009_20/0925 (Other Identifier: sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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