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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Saad NSEIR, University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01082666
First received: February 5, 2010
Last updated: September 18, 2013
Last verified: September 2013
  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 Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilator-associated pneumonia, tracheobronchial colonization, tracheal ischemic lesions [ Time Frame: day 28 after randomization ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Saad NSEIR, MD, PhD, University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01082666     History of Changes
Other Study ID Numbers: 2009-A00431-56, 2008_53/0919
Study First Received: February 5, 2010
Last Updated: September 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014