Efficacy Study of a Novel Device to Clean the Endotracheal Tube

NCT01765530 | Completed Results

• 1 other identifier: MGH-ETT cleaning
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Medical Devices; Ventilator-Associated Pneumonia (VAP); Ventilator-Associated Events (VAE); Endotracheal Tube; Microbial Diversity; Anti-Resistance; Computed Tomography (CT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ETT Microbiology

  At extubation (An expected average of 5 days)

Study Arms (2)

ETT cleaning manuver

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.

Interventions

ETT cleaning maneuver DEVICE

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.

ETT cleaning manuver

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• West Virginia University: collaborator
• endOclear, LLC.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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. doi: 10.1007/s001340051014.

  PMID: 10551961 BACKGROUND

• 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. doi: 10.1097/00003246-198612000-00007.

  PMID: 3780244 BACKGROUND

• 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. doi: 10.1097/00000542-199612000-00013.

  PMID: 8968179 BACKGROUND

• 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.

  PMID: 10071699 BACKGROUND

• Shah C, Kollef MH. Endotracheal tube intraluminal volume loss among mechanically ventilated patients. Crit Care Med. 2004 Jan;32(1):120-5. doi: 10.1097/01.CCM.0000104205.96219.D6.

  PMID: 14707569 BACKGROUND

• Boque 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. doi: 10.1007/s00134-004-2465-4. Epub 2004 Oct 2.

  PMID: 15580475 BACKGROUND

• 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. doi: 10.1097/00000542-199612000-00015.

  PMID: 8968181 BACKGROUND

• 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.

  PMID: 21926595 BACKGROUND

• 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.

  PMID: 21255488 BACKGROUND

• 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. doi: 10.1128/jcm.27.9.2014-2018.1989.

  PMID: 2778064 BACKGROUND

• 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.

  PMID: 19411293 BACKGROUND

• 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. doi: 10.1007/s00134-006-0125-6. Epub 2006 Apr 19.

  PMID: 16601964 BACKGROUND

• 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. doi: 10.1097/00000542-200505000-00028. No abstract available.

  PMID: 15851896 BACKGROUND

MeSH Terms

Conditions

Airway Obstruction; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert M Kacmarek PhD, RRT
• Organization: Massachusetts General Hospital

rkacmarek@partners.org

617-724-4490

Study Officials

• Robert M Kacmarek, PhD, RRT

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Respiratory Care Services; Professor of Anesthesia

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 10, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 18, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-04

Locations

US (1)