Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane

NCT01114022 | Completed DMC

• 2 other identifiers: OST08029ID RCB2008 -A007 12-53
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Failure; Mechanical Ventilation Complication

Keywords

Acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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

  7 days

Secondary Outcomes (2)

• To determine the impact of PAVM

  one month

• To determine the incidence of laryngeal dyspnea with each probe

  one month

Study Arms (4)

Active comparator

ACTIVE COMPARATOR

cylindrical PVC cuff

Device: Active comparator

Experimental 1

EXPERIMENTAL

cylindrical polyurethane cuff

Device: Experimental 1

Experimental 2

EXPERIMENTAL

conic PVC cuff

Device: Experimental

Experimental 3

EXPERIMENTAL

conic polyurethane cuff

Device: experimental 3

Interventions

Experimental 1 DEVICE

oeso pharyngeal device

Also known as: oeso pharyngeal device

Experimental 1

Experimental DEVICE

oeso pharyngeal device

Also known as: oeso pharyngeal device

Experimental 2

experimental 3 DEVICE

oeso pharyngeal device

Also known as: oeso pharyngeal device

Experimental 3

Active comparator DEVICE

oeso pharyngeal device

Also known as: oeso pharyngeal device

Active comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Kimberly-Clark Corporation: collaborator
• Medtronic - MITG: collaborator

Study Sites (1)

Groupe Hospitalier St Joseph

Paris, 75014, France

Location

Related Publications (6)

• Misset B, Timsit JF, Dumay MF, Garrouste M, Chalfine A, Flouriot I, Goldstein F, Carlet J. A continuous quality-improvement program reduces nosocomial infection rates in the ICU. Intensive Care Med. 2004 Mar;30(3):395-400. doi: 10.1007/s00134-003-2096-1. Epub 2003 Dec 12.

  PMID: 14673521 BACKGROUND

• Koenig SM, Truwit JD. Ventilator-associated pneumonia: diagnosis, treatment, and prevention. Clin Microbiol Rev. 2006 Oct;19(4):637-57. doi: 10.1128/CMR.00051-05.

  PMID: 17041138 BACKGROUND

• Garrouste-Orgeas M, Chevret S, Arlet G, Marie O, Rouveau M, Popoff N, Schlemmer B. Oropharyngeal or gastric colonization and nosocomial pneumonia in adult intensive care unit patients. A prospective study based on genomic DNA analysis. Am J Respir Crit Care Med. 1997 Nov;156(5):1647-55. doi: 10.1164/ajrccm.156.5.96-04076.

  PMID: 9372689 BACKGROUND

• Dullenkopf A, Schmitz A, Frei M, Gerber AC, Weiss M. Air leakage around endotracheal tube cuffs. Eur J Anaesthesiol. 2004 Jun;21(6):448-53. doi: 10.1017/s0265021504006064.

  PMID: 15248624 BACKGROUND

• Lucangelo U, Zin WA, Antonaglia V, Petrucci L, Viviani M, Buscema G, Borelli M, Berlot G. Effect of positive expiratory pressure and type of tracheal cuff on the incidence of aspiration in mechanically ventilated patients in an intensive care unit. Crit Care Med. 2008 Feb;36(2):409-13. doi: 10.1097/01.CCM.0000297888.82492.31.

  PMID: 18007268 BACKGROUND

• Philippart F, Gaudry S, Quinquis L, Lau N, Ouanes I, Touati S, Nguyen JC, Branger C, Faibis F, Mastouri M, Forceville X, Abroug F, Ricard JD, Grabar S, Misset B; TOP-Cuff Study Group. Randomized intubation with polyurethane or conical cuffs to prevent pneumonia in ventilated patients. Am J Respir Crit Care Med. 2015 Mar 15;191(6):637-45. doi: 10.1164/rccm.201408-1398OC.

  PMID: 25584431 DERIVED

Study Officials

• Benoit Misset, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: April 30, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

FR (1)