Efficacy Study of a Novel Device to Clean the Endotracheal Tube

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ClinicalTrials.gov Identifier: NCT01765530

Recruitment Status : Completed

First Posted : January 10, 2013

Results First Posted : March 29, 2017

Last Update Posted : October 18, 2017

Sponsor:

Collaborators:

West Virginia University

endOclear, LLC.

Information provided by (Responsible Party):

Robert M. Kacmarek, Massachusetts General Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Endotracheal Extubation Airway Obstruction Airway Control Pneumonia, Ventilator-Associated Breathing Mechanics	Device: ETT cleaning maneuver	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	74 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Endotracheal Tubes Cleaned With a Novel Mechanism for Secretions Removal
Study Start Date :	September 2012
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

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.

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.

Outcome Measures

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765530

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

West Virginia University

endOclear, LLC.

Investigators

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

More Information

Publications:

Adair CG, Gorman SP, Feron BM, Byers LM, Jones DS, Goldsmith CE, Moore JE, Kerr JR, Curran MD, Hogg G, Webb CH, McCarthy GJ, Milligan KR. Implications of endotracheal tube biofilm for ventilator-associated pneumonia. Intensive Care Med. 1999 Oct;25(10):1072-6.

Shapiro M, Wilson RK, Casar G, Bloom K, Teague RB. Work of breathing through different sized endotracheal tubes. Crit Care Med. 1986 Dec;14(12):1028-31.

Heyer L, Louis B, Isabey D, Lofaso F, Brochard L, Fredberg JJ, Harf A. Noninvasive estimate of work of breathing due to the endotracheal tube. Anesthesiology. 1996 Dec;85(6):1324-33.

Glass C, Grap MJ, Sessler CN. Endotracheal tube narrowing after closed-system suctioning: prevalence and risk factors. Am J Crit Care. 1999 Mar;8(2):93-100.

Shah C, Kollef MH. Endotracheal tube intraluminal volume loss among mechanically ventilated patients. Crit Care Med. 2004 Jan;32(1):120-5.

Boqué MC, Gualis B, Sandiumenge A, Rello J. Endotracheal tube intraluminal diameter narrowing after mechanical ventilation: use of acoustic reflectometry. Intensive Care Med. 2004 Dec;30(12):2204-9. Epub 2004 Oct 2.

Villafane MC, Cinnella G, Lofaso F, Isabey D, Harf A, Lemaire F, Brochard L. Gradual reduction of endotracheal tube diameter during mechanical ventilation via different humidification devices. Anesthesiology. 1996 Dec;85(6):1341-9.

Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, Bramati S, Moss J, Pesenti A. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med. 2012 Jan;40(1):119-24. doi: 10.1097/CCM.0b013e31822e9fe3.

Stone RH, Bricknell SS. Experience with a new device for clearing mucus from the endotracheal tube. Respir Care. 2011 Apr;56(4):520-2. doi: 10.4187/respcare.00642. Epub 2011 Jan 21.

Inglis TJ, Millar MR, Jones JG, Robinson DA. Tracheal tube biofilm as a source of bacterial colonization of the lung. J Clin Microbiol. 1989 Sep;27(9):2014-8.

Wilson AM, Gray DM, Thomas JG. Increases in endotracheal tube resistance are unpredictable relative to duration of intubation. Chest. 2009 Oct;136(4):1006-1013. doi: 10.1378/chest.08-1938. Epub 2009 May 1.

Berra L, Curto F, Li Bassi G, Laquerriere P, Baccarelli A, Kolobow T. Antibacterial-coated tracheal tubes cleaned with the Mucus Shaver : a novel method to retain long-term bactericidal activity of coated tracheal tubes. Intensive Care Med. 2006 Jun;32(6):888-93. Epub 2006 Apr 19.

Kolobow T, Berra L, Li Bassi G, Curto F. Novel system for complete removal of secretions within the endotracheal tube: the Mucus Shaver. Anesthesiology. 2005 May;102(5):1063-5.

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Responsible Party:	Robert M. Kacmarek, Director, Respiratory Care Services; Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01765530
Other Study ID Numbers:	MGH-ETT cleaning
First Posted:	January 10, 2013 Key Record Dates
Results First Posted:	March 29, 2017
Last Update Posted:	October 18, 2017
Last Verified:	April 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:

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Pneumonia Pneumonia, Ventilator-Associated Airway Obstruction Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases	Respiration Disorders Pathologic Processes Respiratory Insufficiency Healthcare-Associated Pneumonia Cross Infection Iatrogenic Disease Disease Attributes

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