Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-10-31

Brief Summary

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Patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube

Detailed Description

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Subglottic secretions accumulated above the endotracheal cuff may progress, descending along the channels within folds of the cuff wall, to the lower respiratory tract causing VAP. Subglottic secretion drainage (SSD) appears to be effective in preventing VAP, primarily by reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. We set out the hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from the subglottic area) it should be also possible to reduce the incidence of late-onset VAP.

Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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tube with subglottic drainage and polyurethane cuff

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients expected to require mechanical ventilation for more than 24 hours

Exclusion Criteria

* Age \<18 years,
* Pregnancy,
* HIV,
* Blood leukocytes counts \<1000 cells/mm3,
* Solid or haematological tumour,
* Immunosuppressive therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Leonardo Lorente, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Intensive care unit

References

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Lorente L, Lecuona M, Jimenez A, Mora ML, Sierra A. Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1079-83. doi: 10.1164/rccm.200705-761OC. Epub 2007 Sep 13.

Reference Type DERIVED

PMID: 17872488 (View on PubMed)

Other Identifiers

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01/03/2006

Identifier Type: -

Identifier Source: org_study_id