CeraShield™ Endotracheal Tube Feasibility Study

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.

Study Overview

• Status: Unknown
• Conditions: Intubation, Intratracheal
• Intervention / Treatment: Device: CeraShield Endotracheal Tube

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston Health Sciences Centre
      • Contact: Miranda Hunt; Phone Number: 3190 613 549 6666; Email: miranda.hunt@kingstonhsc.ca
      • Contact: Tracy Boyd; Phone Number: 2608 613 549 6666; Email: tracy.boyd@kingstonhsc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CeraShield Endotracheal Tube; Subjects who are expected to require mechanical ventilation for 24 hours or longer will be intubated with the CeraShield ETT.	Device: CeraShield Endotracheal Tube; Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive QEA	Determine the incidence of subjects with positive QEA in the patients intubated ≥ 24 hours	10 days post intubation
Positive ETT colonization	Determine the incidence of subjects with ETT colonization in the patients intubated ≥ 24 hours	10 days post intubation

Collaborators and Investigators

• Sponsor: N8 Medical, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2018
• Primary Completion (ANTICIPATED): October 30, 2019
• Study Completion (ANTICIPATED): October 30, 2019

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (ACTUAL): October 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N8-2018-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No