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Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane (Top-cuff)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Kimberly-Clark Corporation
Covidien
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01114022
First received: April 29, 2010
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

A number of techniques have been recommended for the prevention of ventilator acquired pneumonia (VAP). These techniques - such as patient positioning, continuous sub-glottic suction of the secretions, selective decontamination of the digestive tract etc… - aim at prevent the inhalation of oro-pharyngeal contaminated secretions around the cuff of the tracheal tube used for connecting the patient to the machine. Their efficacy has been regularly challenged and they are still unable to suppress totally the occurrence of VAP. The cuff of the tracheal tube used for long-term MV in the ICU is most often a low pressure high volume polyvinyl chloride (PVC) cuff in order to adhere to a large surface of the tracheal wall without inducing ischemic lesions. Recent advances allowed industrial companies to provide us with 1) polyurethane cuffs and 2) cuffs with a conic shape, both potentially offering a better tightness against inhalation at least in VITRO and in animal models. The effect on the reduction of VAP incidence has been suggested by several pilot series. The aim of the present project is to assess the efficacy of four types of cuffs (PVC with a conic or a cylinder shape and polyurethane with a conic or a cylinder shape) to prevent tracheal colonisation. We shall measure both oro-pharyngeal and tracheal colonisation during the hours and days following intubation. This will be done in 600 ICU patients of four university affiliated centres from France and Tunisia divided in 64 cluster randomized groups. The results of this research will confirm (or not) the rationale to perform a larger study designed specifically to address the impact on VAP.


Condition Intervention
Acute Respiratory Failure
Mechanical Ventilation Complication
 Device: Experimental 1
Device: Experimental
Device: experimental 3
Device: Active comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Prevention Bacterial Inhalation of Patients on Mechanical Ventilation by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Whether the probes tracheal intubation with a polyurethane balloon or balloon-shaped tapered, or both at once, due to their better seal, are associated with reduced colonization routes from bronchial secretions oro-pharynx [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the impact of PAVM [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • To determine the incidence of laryngeal dyspnea with each probe [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: September 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active comparator
cylindrical PVC cuff
 Device: Active comparator
oeso pharyngeal device
Other Name: oeso pharyngeal device
Experimental: Experimental 1
cylindrical polyurethane cuff
 Device: Experimental 1
oeso pharyngeal device
Other Name: oeso pharyngeal device
Experimental: Experimental 2
conic PVC cuff
 Device: Experimental
oeso pharyngeal device
Other Name: oeso pharyngeal device
Experimental: Experimental 3
conic polyurethane cuff
 Device: experimental 3
oeso pharyngeal device
Other Name: oeso pharyngeal device

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • patients which duration of tracheal intubation expected by the physician is more than 24 h
  • patients intubated by one of the participating ICU
  • adult patients (> 18 years).

Exclusion criteria :

  • Recent (less than a month) tracheal or bronchial surgery.
  • Bronchial dilation or cystic fibrosis
  • Non-intubated patients in ICUs or emergency rooms participating centers.
  • Intubation> 24 hours in the previous 7 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114022

Locations
France
Groupe Hospitalier St Joseph
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Kimberly-Clark Corporation
Covidien
Investigators
Principal Investigator: Benoit Misset, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01114022     History of Changes
Other Study ID Numbers: OST08029, ID RCB2008 -A007 12-53
Study First Received: April 29, 2010
Last Updated: November 29, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute respiratory failure

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 16, 2013