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OpenTrials
Completed

NCT Number: NCT00475579

Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage

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

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Key information

Conditions

Mechanical Ventilation Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tube with subglottic drainage and polyurethane cuff

Procedure

Primary outcomes

  1. Ventilator-associated pneumonia

    Time frame: 8 months

Secondary outcomes

  1. Late-onset ventilator-associated pneumonia

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Canarias

Other

Registry information

Official study title

Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia

Acronym: A/N

Important dates

Study start
2006
Study completion
2006
First posted
May 21, 2007
Registry last updated
May 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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