Ceragenin Coated Endotracheal Tubes for the Prevention of Ventilator Associated Pneumonia

NCT ID: NCT05761613

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2024-12-01

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.

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.

1. 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.

2. 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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Endotracheal Tube with Subglottic Secretion Drainage

All patients in this arm will be intubated with an ETT with subglottic secretion drainage

Group Type: ACTIVE_COMPARATOR

Endotracheal tube with subglottic secretion drainage

Intervention Type: DEVICE

An endotracheal tube with subglottic secretion drainage

CeraShield Endotracheal Tube

All patients in this arm will be intubated with a ceragenin coated ETT

Group Type: ACTIVE_COMPARATOR

CeraShield Endotracheal Tube

Intervention Type: DEVICE

An endotracheal tube coated with with an antimicrobial hydrophilic coating containing ceragenins (CSAs)

Interventions

CeraShield Endotracheal Tube

An endotracheal tube coated with with an antimicrobial hydrophilic coating containing ceragenins (CSAs)

Intervention Type: DEVICE

Endotracheal tube with subglottic secretion drainage

An endotracheal tube with subglottic secretion drainage

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult critically ill patients with respiratory failure requiring intubation

Exclusion Criteria

1. Admission to hospital or ICU with a non-study ETT already in place

2. Presence of a tracheostomy on ICU admission

3. Unable to be intubated with non-study ETT

4. Declined participation in research or data collection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. John Muscedere

OTHER

Sponsor Role: lead

Responsible Party

Dr. John Muscedere

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John MUSCEDERE, MD

Role: PRINCIPAL_INVESTIGATOR

Queens University

Locations

Kingston Health Sciences Center

Kingston, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 16215368 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20597661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21478738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30581995 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18836587 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10735262 (View on PubMed)

Symonds NE, Meng EXM, Boyd JG, Boyd T, Day A, Hobbs H, Maslove DM, Norman PA, Semrau JS, Sibley S, Muscedere J. Ceragenin-coated endotracheal tubes for the reduction of ventilator-associated pneumonia: a prospective, longitudinal, cross-over, interrupted time, implementation study protocol (CEASE VAP study). BMJ Open. 2024 Feb 2;14(2):e076720. doi: 10.1136/bmjopen-2023-076720.

Reference Type: DERIVED

PMID: 38309761 (View on PubMed)

Other Identifiers

6036323

Identifier Type: -

Identifier Source: org_study_id