Efficacy Study of a Novel Device to Clean the Endotracheal Tube
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia, Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 10/20/2017 |
| Start Date: | September 2012 |
| End Date: | December 2013 |
Endotracheal Tubes Cleaned With a Novel Mechanism for Secretions Removal
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.
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.
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.
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.
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
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