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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082666
First Posted: March 8, 2010
Last Update Posted: June 18, 2015
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):
University Hospital, Lille
  Purpose
We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Condition Intervention Phase
Critically Ill Device: Continuous control of cuff pressure Device: Manual control of cuff pressure Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Pepsin level in tracheal aspirate [ Time Frame: 48 h after randomization ]

Secondary Outcome Measures:
  • Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions [ Time Frame: day 28 after randomization ]

Enrollment: 122
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Manual manometer

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.

  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:

  • 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
  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): NCT01082666


Locations
France
ICU, Calmette Hospital, University Hospital of Lille
Lille, Nord, France, 59037
Sponsors and Collaborators
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
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01082666     History of Changes
Other Study ID Numbers: 2008_53/0919
2009-A00431-56 ( Other Identifier: ID-RCB number, ANSM )
First Submitted: February 5, 2010
First Posted: March 8, 2010
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by University Hospital, Lille:
Cuff pressure
microaspiration
pepsin
VAP
Mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes