Clinical trial NCT01765530: Efficacy Study of a Novel Device to Clean the Endotracheal Tube
Official title: Endotracheal Tubes Cleaned With a Novel Mechanism for Secretions Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Extubation
Airway Obstruction
Airway Control
Pneumonia, Ventilator-Associated
Breathing Mechanics
Keywords: Medical Devices
Ventilator-Associated Pneumonia (VAP)
Ventilator-Associated Events (VAE)
Endotracheal Tube
Microbial Diversity
Anti-Resistance
Computed Tomography (CT)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: West Virginia University
name: endOclear, LLC.
First posted: 2013-01-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the in-vivo efficacy of a novel device (endOclear) for cleaning the endotracheal tube (ETT) lumen from secretions. The investigators hypothesize that a protocol of routine ETT cleaning with endOclear may increase the ETT luminal volume measured at extubation compared to the current standard of care. The device may therefore be clinically useful by better maintaining the ETT original function.

Detailed description: After a few days of mechanical ventilation (MV), the lumen of the endotracheal tube (ETT) is coated with a thick bacterial biofilm, which is a potential source for bacterial colonization of the lower respiratory tract and ventilator-associated pneumonia (VAP). Accumulation of mucus/secretions on the interior of the ETT also effectively lowers the cross section of the ETT and increases significantly the work of breathing in intubated patients, who then require increased MV support, with prolonged intubation and ICU stay.

A primary goal for all ICUs is to shorten the time of MV, to decrease the incidence of ETT microbial colonization and ultimately VAP incidence. To meet this goal several airways technologies to maintain the ETT free from debris/bacteria have been developed in order to improve the current ventilator-liberation standards in intubated critically ill patients.

Based on preliminary laboratory, animal and clinical data, The investigators now wish to test the hypothesis that a novel commercially available ETT cleaning device can be effective in targeting two specific issues:

* Specific aim 1: To evaluate the mean difference in ETT luminal volume of ETTs cleaned with the novel cleaning device (EndOclear) vs. ETT cleaned in the standard manner.
* Specific aim 2: To determine whether ETTs cleaned with the novel device show a lower degree of microbial colonization for the entire period of mechanical ventilation.

Data about in-vivo respiratory mechanics measurements, microbial diversity and antibiotic resistance analysis, users' feedbacks and safety of the device will also be collected.

The investigators will conduct a clinical trial on 74 intubated patients randomized to receive standard ETT cleaning or cleaning with the EndOclear.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients expected to be intubated for at least 48 hours or longer
* Enrollment within 24 hours from intubation time

Exclusion Criteria:

* Current and past participation in another intervention trial conflicting with the present study
* Pregnant women and prisoners

Primary outcomes:
measure: Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs
timeFrame: At extubation (An expected average of 5 days)
Secondary outcomes:
measure: ETT Microbiology
timeFrame: At extubation (An expected average of 5 days)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Robert M Kacmarek, PhD, RRT
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Berra L, Curto F, Li Bassi G, Laquerriere P, Baccarelli A, Kolobow T. Antibacterial-coated tracheal tubes cleaned with the Mucus Shaver : a novel method to retain long-term bactericidal activity of coated tracheal tubes. Intensive Care Med. 2006 Jun;32(6):888-93. doi: 10.1007/s00134-006-0125-6. Epub 2006 Apr 19.
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