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Efficacy Study of a Novel Device to Clean the Endotracheal Tube

This study has been completed.
Sponsor:
Collaborators:
West Virginia University
endOclear, LLC.
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01765530
First received: December 28, 2012
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Endotracheal Extubation Airway Obstruction Airway Control Pneumonia, Ventilator-Associated Breathing Mechanics Device: ETT cleaning maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Prevention
Official Title: Endotracheal Tubes Cleaned With a Novel Mechanism for Secretions Removal

Further study details as provided by Robert M. Kacmarek, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • ETT Microscopic Imaging [ Time Frame: At extubation (An expected average of 5 days) ]
    Exploratory outcome include microscopy imaging of distribution of bacteria on the ETT surface.

  • In-vivo Respiratory Mechanics [ Time Frame: During intubation ]
    Respiratory mechanics are exploratory data to evaluate respiratory function

  • User's Feedback [ Time Frame: During intubation ]
    Questionnaires to healthcare provider were collected to evaluate the use of the device.

  • ETT Weight Gain [ Time Frame: After extubation ]
    Gross weight of the ETT was measured at extubation, when possible.


Enrollment: 74
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

The ETT cleaning maneuver will be performed through the endOclear device. This 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. 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 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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765530

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
West Virginia University
endOclear, LLC.
Investigators
Principal Investigator: Robert M Kacmarek, PhD, RRT Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Robert M. Kacmarek, Director, Respiratory Care Services; Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01765530     History of Changes
Other Study ID Numbers: MGH-ETT cleaning
Study First Received: December 28, 2012
Results First Received: October 26, 2016
Last Updated: April 13, 2017

Keywords provided by Robert M. Kacmarek, Massachusetts General Hospital:
Medical Devices
Ventilator-Associated Pneumonia (VAP)
Ventilator-Associated Events (VAE)
Endotracheal Tube
Microbial Diversity
Anti-Resistance
Computed Tomography (CT)

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Airway Obstruction
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Respiratory Insufficiency
Respiration Disorders

ClinicalTrials.gov processed this record on June 26, 2017