Efficacy Study of a Novel Device to Clean the Endotracheal Tube

Airway Obstruction Clinical Trial

Official title:

Endotracheal Tubes Cleaned With a Novel Mechanism for Secretions Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765530
• Other study ID #: MGH-ETT cleaning
• Status: Completed
• Phase: N/A
• First received: December 28, 2012
• Last updated: September 18, 2017
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	endOclear, LLC., West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs	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	ETT Microbiology	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)