Efficacy Study of a Novel Device to Clean the Endotracheal Tube

September 18, 2017 updated by: Robert M. Kacmarek, Massachusetts General Hospital

Endotracheal Tubes Cleaned With a Novel Mechanism for Secretions Removal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After a few days of mechanical ventilation (MV), the lumen of the endotracheal tube (ETT) is coated with a thick bacterial biofilm, which is a potential source for bacterial colonization of the lower respiratory tract and ventilator-associated pneumonia (VAP). Accumulation of mucus/secretions on the interior of the ETT also effectively lowers the cross section of the ETT and increases significantly the work of breathing in intubated patients, who then require increased MV support, with prolonged intubation and ICU stay.

A primary goal for all ICUs is to shorten the time of MV, to decrease the incidence of ETT microbial colonization and ultimately VAP incidence. To meet this goal several airways technologies to maintain the ETT free from debris/bacteria have been developed in order to improve the current ventilator-liberation standards in intubated critically ill patients.

Based on preliminary laboratory, animal and clinical data, The investigators now wish to test the hypothesis that a novel commercially available ETT cleaning device can be effective in targeting two specific issues:

  • Specific aim 1: To evaluate the mean difference in ETT luminal volume of ETTs cleaned with the novel cleaning device (EndOclear) vs. ETT cleaned in the standard manner.
  • Specific aim 2: To determine whether ETTs cleaned with the novel device show a lower degree of microbial colonization for the entire period of mechanical ventilation.

Data about in-vivo respiratory mechanics measurements, microbial diversity and antibiotic resistance analysis, users' feedbacks and safety of the device will also be collected.

The investigators will conduct a clinical trial on 74 intubated patients randomized to receive standard ETT cleaning or cleaning with the EndOclear.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients expected to be intubated for at least 48 hours or longer
  • Enrollment within 24 hours from intubation time

Exclusion Criteria:

  • Current and past participation in another intervention trial conflicting with the present study
  • Pregnant women and prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ETT cleaning manuver
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.
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.
No Intervention: Standard of care
In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs
Time Frame: At extubation (An expected average of 5 days)
The investigators will measure percentage of occlusion determined by the accumulation of secretion within the lumen of each ETT using a high definition Computed Tomography (CT) imaging of the extubated ETTs. The whole ETT will be analyzed through high-definition CT slices. 100% of occlusion means total occlusion of the lumen of the ETT and 0% means absence of any occlusion.
At extubation (An expected average of 5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ETT Microbiology
Time Frame: At extubation (An expected average of 5 days)
For each patient a quantitative culture will be obtained from the ETT after extubation. Secretions will be retrieved from the ETT after CT scan and quantitative standard cultures will be performed. Microbial molecular diversity analysis and antibacterial resistance patterns will also be studied.
At extubation (An expected average of 5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

West Virginia University
endOclear, LLC.

Investigators

  • Principal Investigator: Robert M Kacmarek, PhD, RRT, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 28, 2012

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 10, 2013

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGH-ETT cleaning

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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