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Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube

Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube: a Randomized Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01912105
Enrollment
40
Registered
2013-07-30
Start date
2013-04-30
Completion date
2014-07-31
Last updated
2015-08-25

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

Conditions

Expected Duration of Ventilation > 48h, Intubation

Keywords

endotracheal tube, ct scan, cleaning device, biofilm, mechanical ventilation

Brief summary

Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan

Interventions

DEVICEstandard closed suctioning systems

Sponsors

Azienda Ospedaliera San Gerardo di Monza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Patients admitted to an ICU * 18 years old or more * expected to be intubated for more than 48 hours * less than 24 hours from intubation * fraction of inspired oxygen set at the ventilator \<80%

Exclusion criteria

* Current or past participation in another intervention trial conflicting with the present study * expected survival less than 24 hours * Acute severe asthma * Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO * Double lumen endotracheal tube in place * Conditions which pose the patient at high risk if inadvertent endotracheal tube displacement occurs (laryngeal edema, cervical spine trauma, upper airways diseases with difficult reintubation) * other contraindications posed by staff physicians

Design outcomes

Primary

MeasureTime frameDescription
Volume of secretionswithin 12 hours after extubationVolume of secretions retained inside the endotracheal tube, assessed by micro ct scan

Secondary

MeasureTime frameDescription
adverse eventsuntil extubation, death or tracheostomy (approximately 2 weeks)report of major and minor adverse events related to the use of the device

Other

MeasureTime frameDescription
endotracheal tube colonizationwithin 48 hours after extubationassessed by microbiologic testing of the endotracheal tube lavage fluid

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026