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OpenTrials
Completed

NCT Number: NCT00219661

Effect of Drainage of Subglottic Secretions on Pneumonia Acquired Under Mechanical Ventilation

The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Avignon Hospital, Avignon, France

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About this study

Nosocomial infection represent a major problem in hospitals. In intensive care units, ventilator-associated pneumonia (VAP) is associated with an increase in morbidity and mortality. Incidence of VAP is high, 20 to 30% of patients under mechanical ventilation (MV) for more than 48 hours. In the pathogenesis of VAP, two processes are considered essential for its development: bacterial colonization of the oropharynx and tracheobronchial tract, followed by aspiration of contaminated secretions into the lower airways. It has been shown that pooled secretions above inflated endotracheal tube cuffs may be source of aspiration and can be a cause of VAP. Several studies have suggested that recurrent aspiration of subglottic secretions can be prevented by intermittent drainage of subglottic secretions. Nevertheless, recent CDC guideline reported that there was not enough evidence to conclude on the efficacy of such intervention.

During the study, patients, in both groups, will be intubated with the same device permitting subglottic drainage (HiLo Evac endotracheal tube). The daily screening of VAP will be performed until the 28th days of mechanical ventilation without occurrence of VAP. The follow-up of each patient will be realized until the ICU's discharge.

Comparison: The incidence of VAP will be compared between two groups: one group with intermittent drainage of subglottic secretions and the other one without this intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ICU patients expected to require MV more than 48 hours

Exclusion criteria

  • patients already intubated for more than 12 hours
  • patients intubated with another tube than the HiLo Evac tube
  • patients admitted for cardiac arrest
  • patients admitted for self poisoning
  • patients admitted with tracheotomy
  • patients already included in an another clinical trial

Treatment and study plan

drainage of subglottic secretions (HiLo Evac tube)

Procedure

Primary outcomes

  1. Incidence of ventilator-associated pneumonia(VAP)

Secondary outcomes

  1. Duration on mechanical ventilation (MV)

  2. Prior duration of MV before occurrence of VAP

  3. duration of ICU's stay

  4. Rate of tracheotomy

  5. ICU's mortality

  6. Microbiology of the VAP

Sponsors and collaborators

Lead sponsor

Poissy-Saint Germain Hospital

Other

Registry information

Official study title

Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial

Important dates

Study start
2003
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Apr 23, 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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