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| Name | Class |
|---|---|
| West Virginia University | OTHER |
| endOclear, LLC. | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Kacmarek, PhD, RRT | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10551961 | Background | 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. | |
| 3780244 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of occlusion | At extubation (An expected average of 5 days) |
|
Entire study 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert M Kacmarek PhD, RRT | Massachusetts General Hospital | 617-724-4490 | rkacmarek@partners.org |
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| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
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|
| 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. |
| 8968179 | 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. |
| 10071699 | 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. |
| 14707569 | 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. |
| 15580475 | 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. |
| 8968181 | 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. |
| 21926595 | 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. |
| 21255488 | 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. |
| 2778064 | 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. |
| 19411293 | 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. |
| 16601964 | 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. |
| 15851896 | 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. |
In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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. |
|
|
| 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. | Posted | Mean | Standard Error | Log colony form unit (CFU)/ mL | At extubation (An expected average of 5 days) |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | 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. | 0 | 36 | 0 | 36 |
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| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |