CeraShield™ Endotracheal Tube Feasibility Study

Intubation, Intratracheal Clinical Trial

Official title:

CeraShield™ Endotracheal Tube Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716713
• Other study ID #: N8-2018-02
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: August 2019
• Source: N8 Medical, LLC
• Contact: Jane Wilson
• Phone: 845-721-8210
• Email: janew[@]databean.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-arm, feasibility study to evaluate the Ceragenin Coated Endotracheal Tube (the CeraShield ETT) in adults who require intubation and are expected to be mechanically ventilated for ≥ 24 hours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18 years or older;

• Patients requiring a 7.0mm, 7.5mm, 8.0mm or 8.5mm endotracheal tube;

• Expected to be mechanically ventilated for =24 hours.

Exclusion Criteria:

• Currently participating in another clinical trial which conflicts with this trial's design.

• Patients with a pre-existing respiratory infection, i.e., pneumonia.

• Patients with pulmonary contusions.

• Patients with cystic fibrosis.

• Patients demonstrating symptoms of bronchiectasis.

• Patients demonstrating symptoms of severe or massive hemoptysis. Severe or massive hemoptysis defined as greater than 500 ml of blood per day, or greater than 200 ml in six hours.

• Patients who have been intubated within the last 30 days requiring reintubation.

• Women of child-bearing potential who have not undergone a pregnancy test will be excluded from the study.

• Patient is pregnant.

Related Conditions & MeSH terms

• Intubation, Intratracheal

Intervention

Device:
• CeraShield Endotracheal Tube
Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
N8 Medical, LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	The safety of the CeraShield ETT tube will be assessed by reviewing adverse events in all patients enrolled in the study	Up to 30 days post enrollment or hospital discharge, whichever comes first
Secondary	Positive QEA	Determine the incidence of subjects with positive QEA in the patients intubated = 24 hours	10 days post intubation
Secondary	Positive ETT colonization	Determine the incidence of subjects with ETT colonization in the patients intubated = 24 hours	10 days post intubation