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Occurrence of Ventilator Associated Pneumonia in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage

Occurrence of Ventilator Associated Pneumonia (VAP) in Italian ICU Using Cuffed Tracheostomy Tubes With Subglottic Secretion Drainage: a Prospective Observational Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02223988
Acronym
VICTOR
Enrollment
100
Registered
2014-08-22
Start date
2014-07-31
Completion date
2016-07-31
Last updated
2017-05-09

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

Conditions

Respiratory Failure

Keywords

Patients, mechanical, ventilation, tracheostomy

Brief summary

Ventilator-associated pneumonia (VAP) is a serious complication and carries increased risks of morbidity and mortality for patients who require mechanical ventilation. VAP is associated with the contamination and colonization of bacteria in the lower airway. These bacteria may be present in the lower airway by the aspiration of oropharyngeal secretions. Therefore limiting the amount of secretions that pass the glottis and enter the airway is paramount. Patients who require prolonged mechanical ventilation may have a tracheostomy tube placed to manage breathing. These tubes may have a distal cuff which sits within the trachea. When the cuff is inflated, oropharyngeal secretions will pool above the cuff of the tracheostomy tube thereby limiting the amount of secretions entering the lower airway. These secretions may leak around the cuff and cause tracheobronchial colonization. It has been shown that removal of secretions that pool above the cuff via dorsal lumen suction leads to a decreased incidence of VAP. The purpose of this study is to measure the effect of suction above the cuff tracheostomy tubes related to VAP incidence

Interventions

PROCEDUREsubglottic secretion removal

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

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

Inclusion criteria

* Patients on mechanical ventilation for respiratory failure for at least 72 hours. * A score of 35 to 65 on the Simplified Acute Physiology Score II (SAPS II). * Does not have a pulmonary infection estimated by a Clinical Pulmonary Infection Score (CPIS). * Age \>= 18 years. * have no

Design outcomes

Primary

MeasureTime frame
Incidence of VAPat 28 days

Secondary

MeasureTime frameDescription
Mortality rateat 28 daysMortality at 28-day (all-cause mortality) starting from enrollment (at tracheostomy time)
Duration of mechanical ventilation30 days
ICU length of stay30 days
Ventilator free days after tracheostomy28 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026