Clinical trial NCT02120001: Efficacy Study on Silver-coated ETT Cleaned With a Novel Device
Official title: Silver-coated Endotracheal Tube Cleaned With a Novel Mechanism for Secretion Removal: a Randomized Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Critically Ill
Keywords: Medical Devices
Ventilator-Associated Pneumonia (VAP)
Ventilator-Associated Events (VAE)
Endotracheal Tube
Microbial Diversity
Drug-Resistance
biofilms
endotracheal intubation
mechanical ventilation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Rhode Island Hospital
First posted: 2014-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Endotracheal Tube Colonization
timeFrame: At extubation (an expected average of 7 days)
Secondary outcomes:
measure: Microbiological Colonization of Distal Airways
timeFrame: At extubation (An expected average of 7 days)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Robert Kacmarek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pirrone M, Imber DA, Marrazzo F, Pinciroli R, Zhang C, Bry L, Delaney ML, Dubois AM, Thomas JG, Nistico L, Melton-Kreft R, Bittner EA, Kacmarek RM, Berra L. Silver-Coated Endotracheal Tubes Cleaned With a Mechanism for Secretion Removal. Respir Care. 2019 Jan;64(1):1-9. doi: 10.4187/respcare.06222. Epub 2018 Sep 4.