CEASEVAP: Ceragenin Coated Endotracheal Tubes for the Prevention of Ventilator Associated Pneumonia
Study Details
Study Description
Brief Summary
Critically ill patients are at high risk of acquiring pneumonia during the time that they are mechanically ventilated. This is known as ventilator-associated pneumonia (VAP). VAP results in increased duration of mechanical ventilation, increased ICU and hospital stay, increased risk of death and increased health care costs. VAP occurs in 20% of patients and it is estimated that each case of VAP costs the health care system $10 to 15,000 Canadian. Because of its impact on patient outcomes and the health care system, VAP is regarded as an important patient safety issue and there is an urgent need for better prevention strategies.
Invasive mechanical ventilation requires the passage of an endotracheal tube (ETT) through the pharynx which is frequently colonized with bacterial pathogens and a bio-film rapidly forms on the ETT. VAP results either from aspiration of contaminated oropharyngeal secretions or from aspiration of bacteria from the bio-film. In this project, the efficacy of a novel ETT coated with an antibiotic compound that has been shown to reduce the formation of bio-film and pathogen colonization will be tested. Preliminary evidence as to whether utilization of this novel ETT reduces the occurrence of VAP and improves patient outcomes will be obtained through the conduct of a pragmatic, prospective, longitudinal, interrupted time, cross-over implementation study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The innovation that is being studied is a novel antibiotic coated endotracheal tube (ETT) for the prevention of ventilator associated pneumonia (VAP) in critically ill, mechanically ventilated patients. The novel ETT is the CeraShield ETT consisting of a standard ETT with an antimicrobial hydrophilic coating containing ceragenins (CSAs) on the inner and outer lumen of the device, as well as the inflatable cuff. The CSA coating on the CeraShield protects it from microbial colonization and bio-film growth. The CSA ETT is otherwise equivalent to standard ETT tubes currently in use and is licensed in Canada for clinical use as a Class 2 device.
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It is hypothesized that CSA coated ETTs will reduce the incidence of Ventilator Associated Pneumonia and improve clinical outcomes including antibiotic utilization when compared to ETTs currently in use.
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It is hypothesized that a definitive cluster randomized multi-center study is feasible and supported by the data from this study.
To test the hypotheses, an Interrupted Time Series Cross-Over Implementation Study will be used to provide preliminary evidence of the efficacy of the CeraShield ETT compared to the ETT currently used at the study center in critically ill mechanically ventilated patients. This study will inform and be modified to conduct a future large multi-center cluster randomized study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Endotracheal Tube with Subglottic Secretion Drainage All patients in this arm will be intubated with an ETT with subglottic secretion drainage |
Device: Endotracheal tube with subglottic secretion drainage
An endotracheal tube with subglottic secretion drainage
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| Active Comparator: CeraShield Endotracheal Tube All patients in this arm will be intubated with a ceragenin coated ETT |
Device: CeraShield Endotracheal Tube
An endotracheal tube coated with with an antimicrobial hydrophilic coating containing ceragenins (CSAs)
|
Outcome Measures
Primary Outcome Measures
- Occurrence of Ventilator Associated Pneumonia [Admission to within 48 hours of cessation of invasive mechanical ventilation or 28 days]
The primary outcome will be the occurrence of VAP defined as new, progressive, or persistent radiographic infiltrate on chest radiograph plus any 2 of the following: (1) fever (core temperature >38°C) or hypothermia (temperature <36°C); (2) white blood cell count less than 3.0 × 106/L or exceeding 10 × 106/L, and (3) purulent sputum
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult critically ill patients with respiratory failure requiring intubation
Exclusion Criteria:
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Admission to hospital or ICU with a non-study ETT already in place
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Presence of a tracheostomy on ICU admission
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Unable to be intubated with non-study ETT
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Declined participation in research or data collection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kingston Health Sciences Center | Kingston | Ontario | Canada | K7L2V7 |
Sponsors and Collaborators
- Queen's University
Investigators
- Principal Investigator: John MUSCEDERE, MD, Queens University
Study Documents (Full-Text)
None provided.More Information
Publications
- Diaconu O, Siriopol I, Polosanu LI, Grigoras I. Endotracheal Tube Biofilm and its Impact on the Pathogenesis of Ventilator-Associated Pneumonia. J Crit Care Med (Targu Mures). 2018 Apr 1;4(2):50-55. doi: 10.2478/jccm-2018-0011. eCollection 2018 Apr.
- Epand RM, Epand RF, Savage PB. Ceragenins (cationic steroid compounds), a novel class of antimicrobial agents. Drug News Perspect. 2008 Jul-Aug;21(6):307-11. doi: 10.1358/dnp.2008.21.6.1246829.
- Grimshaw J, Campbell M, Eccles M, Steen N. Experimental and quasi-experimental designs for evaluating guideline implementation strategies. Fam Pract. 2000 Feb;17 Suppl 1:S11-6. doi: 10.1093/fampra/17.suppl_1.s11.
- Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. doi: 10.1097/CCM.0b013e318218a4d9.
- Muscedere JG, Day A, Heyland DK. Mortality, attributable mortality, and clinical events as end points for clinical trials of ventilator-associated pneumonia and hospital-acquired pneumonia. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S120-5. doi: 10.1086/653060.
- Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Crit Care Med. 2005 Oct;33(10):2184-93. doi: 10.1097/01.ccm.0000181731.53912.d9.
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