Intubation, IntratrachealNCT03716713
CeraShield™ Endotracheal Tube Feasibility Study
A study testing CeraShield Endotracheal Tube in people with Intubation, Intratracheal, run by N8 Medical, LLC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- CeraShield Endotracheal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Miranda Hunt, 613 549 6666 ext. 3190, miranda.hunt@kingstonhsc.ca
Tracy Boyd, 613 549 6666 ext. 2608, tracy.boyd@kingstonhsc.ca
About this 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.
- Conditions
- Intubation, Intratracheal
- Being tested
- CeraShield Endotracheal Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraShield Endotracheal TubeDevice
Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT
| Study group | Role | What they receive |
|---|---|---|
| CeraShield Endotracheal Tube | Experimental | Subjects who are expected to require mechanical ventilation for 24 hours or longer will be intubated with the CeraShield ETT. Receives: Device: CeraShield Endotracheal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 days post enrollment or hospital discharge, whichever comes first
Secondary outcomes (2)
Positive QEA
Determine the incidence of subjects with positive QEA in the patients intubated ≥ 24 hours
Measured: 10 days post intubation
Positive ETT colonization
Determine the incidence of subjects with ETT colonization in the patients intubated ≥ 24 hours
Measured: 10 days post intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start30 Nov 2018
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N8 Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716713
- Sponsor's protocol ID
- N8-2018-02
- Status last verified
- Aug 2019
- First submitted
- 19 Oct 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CeraShield™ Endotracheal Tube Feasibility Study
- ClinicalTrials.gov ID
- NCT03716713
- Acronym / sponsor ID
- N8-2018-02
- Conditions
- Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- N8 Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CeraShield Endotracheal Tube | Experimental | Device: CeraShield Endotracheal TubeSubjects who are expected to require mechanical ventilation for 24 hours or longer will be intubated with the CeraShield ETT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraShield Endotracheal TubeSubjects requiring mechanical ventilation with be intubated with the CeraShield ETT | Device | CeraShield Endotracheal Tube |
Primary outcome
Incidence of Adverse Events
Time frame: Up to 30 days post enrollment or hospital discharge, whichever comes first
The safety of the CeraShield ETT tube will be assessed by reviewing adverse events in all patients enrolled in the study
2 secondary outcomes
Positive QEA
Time frame: 10 days post intubation
Positive ETT colonization
Time frame: 10 days post intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Intubation, Intratracheal
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
Not yet recruitingObservational study
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CeraShield Endotracheal Tube in people with Intubation, Intratracheal, run by N8 Medical, LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Wilson (845-721-8210, janew@databean.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Up to 30 days post enrollment or hospital discharge, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.