CeraShield™ Endotracheal Tube Feasibility Study

N8 Medical

Status

Unknown

Conditions

Intubation, Intratracheal

Treatments

Device: CeraShield Endotracheal Tube

Study type

Interventional

Funder types

Industry

Identifiers

NCT03716713

N8-2018-02

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.