Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

June 17, 2015 updated by: University Hospital, Lille

Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.

In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Study Type

Interventional

Enrollment (Actual)

122

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, University Hospital of 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:

  • age > or = 18 years
  • tracheal intubation using a polyvinylchloride tube
  • predictible duration of mechanical ventilation > 48 h
  • enteral nutrition

Exclusion Criteria:

  • refuse to participate to the study
  • no informed consent
  • contra-indication for semirecumbment position

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous control
Continuous control of cuff pressure using a pneumatic device
Device: Continuous control of cuff pressure
Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)
Other Names:
  • Automatic control of cuff pressure (Rusch, Kernen, Germany)
Active Comparator: Manual control
Manual control of cuff pressure is a routine practice in ICU patients
Device: Manual control of cuff pressure
Manual control of cuff pressure is a routine practice in ICU patients
Other Names:
  • Manual manometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pepsin level in tracheal aspirate
Time Frame: 48 h after randomization
48 h after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions
Time Frame: day 28 after randomization
day 28 after randomization

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Study Director: Alain Durocher, MD, CHRU de Lille
  • Study Director: Malika Balduyck, MD, CHU de Lille
  • Study Director: Farid Zerimech, MD, CHU de Lille

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

October 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

March 5, 2010

First Posted (Estimate)

March 8, 2010

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008_53/0919
  • 2009-A00431-56 (Other Identifier: ID-RCB number, ANSM)

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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