Recruiting

CeraShield™

Sponsor:

N8 Medical, LLC

Code:

NCT03716713

Conditions

Intubation, Intratracheal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CeraShield Endotracheal Tube

Study Details

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.

Conditions

Intubation, Intratracheal

Study ID

NCT03716713

Start date

Nov 30, 2018

Status verified date

Aug, 2019

Completion date

Oct 30, 2019

Anticipated

Primary completion date

Oct 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: CeraShield Endotracheal Tube

Subjects who are expected to require mechanical ventilation for 24 hours or longer will be intubated with the CeraShield ETT.

Interventions

CeraShield Endotracheal Tube

Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT

Primary outcome measure

  • Incidence of Adverse Events [ Time Frame: Up to 30 days post enrollment or hospital discharge, whichever comes first ]

Central Contacts and Locations

Central contacts

Jane Wilson

845-721-8210janew@databean.com

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Miranda Hunt

613 549 6666miranda.hunt@kingstonhsc.ca

Tracy Boyd

613 549 6666tracy.boyd@kingstonhsc.ca

Principal Investigator:

John Muscedere, MD

More Information

Sponsor

N8 Medical, LLC

Last update posted

Aug 20, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by N8 Medical, LLC on 2019-08-20.