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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00219661
Enrollment
440
Registered
2005-09-22
Start date
2003-06-30
Completion date
2006-09-30
Last updated
2007-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU's Patients Under Mechanical Ventilation

Keywords

randomised control trial, intensive care unit, mechanical ventilation, ventilator-associated pneumonia, drainage of subglottic secretions

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREdrainage of subglottic secretions (HiLo Evac tube)

Sponsors

Poissy-Saint Germain Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of ventilator-associated pneumonia(VAP)

Secondary

MeasureTime frame
Duration on mechanical ventilation (MV)
Prior duration of MV before occurrence of VAP
duration of ICU's stay
Rate of tracheotomy
ICU's mortality
Microbiology of the VAP

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026