Efficacy Study on Silver-coated ETT Cleaned With a Novel Device

Not Applicable

Completed

Conditions: Ventilator Associated Pneumonia
Critically Ill

Interventions: Device: ETT cleaning maneuver

Registration Number: NCT02120001

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETT cleaning maneuver	ETT cleaning maneuver	Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.

Primary Outcome Measures

Name	Time	Method
Endotracheal Tube Colonization	At extubation (an expected average of 7 days)	Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).

Secondary Outcome Measures

Name	Time	Method
Microbiological Colonization of Distal Airways	At extubation (An expected average of 7 days)	Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a specimen from the distal airways immediately before extubation.