CeraShield™ Endotracheal Tube Feasibility Study

Not Applicable

• Conditions: Intubation, Intratracheal

• Registration Number: NCT03716713
• Lead Sponsor: N8 Medical, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-23
• Study Start: 2018-11-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	Up to 30 days post enrollment or hospital discharge, whichever comes first	The safety of the CeraShield ETT tube will be assessed by reviewing adverse events in all patients enrolled in the study

Secondary Outcome Measures

Name	Time	Method
Positive ETT colonization	10 days post intubation	Determine the incidence of subjects with ETT colonization in the patients intubated ≥ 24 hours
Positive QEA	10 days post intubation	Determine the incidence of subjects with positive QEA in the patients intubated ≥ 24 hours

Trial Locations

Locations (1)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada