Efficacy Study on Silver-coated ETT Cleaned With a Novel Device
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia, Pneumonia, Hospital |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | August 2015 |
Silver-coated Endotracheal Tube Cleaned With a Novel Mechanism for Secretion Removal: a Randomized Controlled Clinical Study.
The purpose of this study is to test the efficacy of a novel cleaning device in keeping
silver-coated endotracheal tubes free from bacterial colonization.
silver-coated endotracheal tubes free from bacterial colonization.
Several studies have suggested that biofilm formation inside the ETT plays a pivotal role in
VAP development and drug-resistance induction. Silver-coated ETT have proven effective in
delaying but not in preventing ETT colonization and biofilm formation, due to a barrier
effect of biofilm and accumulated debris. Advanced ETT cleaning devices are able to remove
debris and biofilm and reduce the total ETT microbial load to a certain extent. The
Investigators hypothesize that the routine use of endOclear in patients intubated with a
silver-coated ETT will reduce ETT microbial colonization. The Investigators therefore want
to assess the reduction of ETT microbial colonization in patients intubated with a
silver-coated ETT and cleaned with endOclear compared to the current standard of care of
silver-coated ETT (blind suctioning). They plan to achieve this result by analyzing the
tubes of each enrolled patient after it has been removed, either because the patient does
not need it anymore due to his/her better clinical conditions, or because there is a need of
tracheostomy or because he/she dies. Specifically they will analyze how the endOclear
cleaning maneuver affects microbial colonization in the inner layer of the ETT and how this
can determine distal airway inoculation and, ultimately, VAP development.
Specific AIM #1: Investigators will test the hypothesis that routine use of endOclear in
patients intubated with a silver-coated ETT will reduce ETT microbial colonization.
Specific AIM #2: Investigators will test the hypothesis that keeping ETTs free from
microbial colonization will prevent septic inoculation of distal airways
Specific AIM #3: Investigators will test the hypothesis that prevention of ETT biofilm
development will reduce drug resistance rates found in ETT and distal airways isolates
The investigators will conduct a randomized clinical trial on 40 patients intubated with
silver-coated ETT and randomized to receive standard ETT cleaning vs cleaning with the
endOclear device.
VAP development and drug-resistance induction. Silver-coated ETT have proven effective in
delaying but not in preventing ETT colonization and biofilm formation, due to a barrier
effect of biofilm and accumulated debris. Advanced ETT cleaning devices are able to remove
debris and biofilm and reduce the total ETT microbial load to a certain extent. The
Investigators hypothesize that the routine use of endOclear in patients intubated with a
silver-coated ETT will reduce ETT microbial colonization. The Investigators therefore want
to assess the reduction of ETT microbial colonization in patients intubated with a
silver-coated ETT and cleaned with endOclear compared to the current standard of care of
silver-coated ETT (blind suctioning). They plan to achieve this result by analyzing the
tubes of each enrolled patient after it has been removed, either because the patient does
not need it anymore due to his/her better clinical conditions, or because there is a need of
tracheostomy or because he/she dies. Specifically they will analyze how the endOclear
cleaning maneuver affects microbial colonization in the inner layer of the ETT and how this
can determine distal airway inoculation and, ultimately, VAP development.
Specific AIM #1: Investigators will test the hypothesis that routine use of endOclear in
patients intubated with a silver-coated ETT will reduce ETT microbial colonization.
Specific AIM #2: Investigators will test the hypothesis that keeping ETTs free from
microbial colonization will prevent septic inoculation of distal airways
Specific AIM #3: Investigators will test the hypothesis that prevention of ETT biofilm
development will reduce drug resistance rates found in ETT and distal airways isolates
The investigators will conduct a randomized clinical trial on 40 patients intubated with
silver-coated ETT and randomized to receive standard ETT cleaning vs cleaning with the
endOclear device.
Inclusion Criteria:
- Admission to Medical, Surgical or Neuro ICU
- Subjects must be enrolled within 24 hours from intubation
- Subjects expected to be intubated for at least 48 hours or longer
- Subjects have been intubated with a silver-coated ETT
Exclusion Criteria:
- Current and past participation in another interventional trial conflicting with the
present study
- Pregnant women
- Prisoner status
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