CeraShield™ Endotracheal Tube Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Intubation, Intratracheal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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CeraShield Endotracheal Tube

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

Group Type EXPERIMENTAL

CeraShield Endotracheal Tube

Intervention Type DEVICE

Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT

Interventions

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CeraShield Endotracheal Tube

Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No