NCT03716713

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

October 19, 2018

Last Update Submit

August 19, 2019

Conditions

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Positive QEA

    10 days post intubation

  • Positive ETT colonization

    10 days post intubation

Study Arms (1)

CeraShield Endotracheal Tube

EXPERIMENTAL

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

Device: CeraShield Endotracheal Tube

Interventions

CeraShield Endotracheal TubeDEVICE

Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT

CeraShield Endotracheal Tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Central Study Contacts

Jane Wilson

CONTACT

845-721-8210janew@databean.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2018

First Posted

October 23, 2018

Study Start

November 30, 2018

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

CA(1)