MedTrace Logo

Efficacy Study of a Novel Device to Clean the Endotracheal Tube

NCT01765530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-10-18

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Endotracheal Extubation
  • Airway Obstruction
  • Airway Control
  • Pneumonia, Ventilator-Associated
  • Breathing Mechanics

Interventions

DEVICE

ETT cleaning maneuver

EndOclear device will be used for ETT cleaning maneuver. This is a commercially available device. It consists of an ETT cleaning apparatus with a flexible central tube and a cleaning device at its distal end. The cleaning device has a mechanically expandable mesh structure which can be adapted to selectively move between a radially-collapsed position and a radially-expanded one. 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 ETT. The cleaning apparatus is then pulled out of the ETT removing mucus deposits and secretions. We will add endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period.

Sponsors & Collaborators

  • West Virginia University

    collaborator OTHER

  • endOclear, LLC.

    collaborator UNKNOWN

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Robert M Kacmarek, PhD, RRT · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01765530 on ClinicalTrials.gov