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

NCT02120001 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-19

Study results available
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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.

Conditions

  • Ventilator Associated Pneumonia
  • Critically Ill

Interventions

DEVICE

ETT cleaning maneuver

EndOclear is a commercially available device. It consists of an endotracheal tube cleaning apparatus with a flexible central tube and a cleaning device at its distal end. In operation, the collapsed cleaning apparatus is inserted into the ETT through a Y-shaped connector. The device is then expanded by a safety toggle protected trigger mechanism that, when fired, presses the device's smooth silicone disc against the inside surface of the endotracheal tube. The cleaning apparatus is then pulled out of the endotracheal tube removing mucus deposits and secretions. We plan to add the use of endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Rhode Island Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Robert Kacmarek, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120001 on ClinicalTrials.gov