NCT00475579

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
Last Updated

May 21, 2007

Status Verified

May 1, 2007

First QC Date

May 17, 2007

Last Update Submit

May 17, 2007

Conditions

Mechanical Ventilation

Keywords

ventilator-associated pneumoniaendotracheal tubepolyurethane cuffpolyvinyl cuffsubglottic secretion drainage

Outcome Measures

Primary Outcomes (1)

  • Ventilator-associated pneumonia

    8 months

Secondary Outcomes (1)

  • Late-onset ventilator-associated pneumonia

    8 months

Interventions

tube with subglottic drainage and polyurethane cuffPROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17872488DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leonardo Lorente, MD, PhD

    Intensive care unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2007

First Posted

May 21, 2007

Study Start

March 1, 2006

Study Completion

October 1, 2006

Last Updated

May 21, 2007

Record last verified: 2007-05