IntubationNCT03328182

Assessment of an Oral Endotracheal Subglottic Tube Holder

A study testing New oral endotracheal tube holder in people with Intubation, run by Hollister Incorporated at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intubation
What is being tested?: New oral endotracheal tube holder
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 4 sitesUnited States
Study dates: 23 Oct 2017to 15 Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
Requires the use of a bite block per the hospital's standard of care
Has intact skin on and around application site, including cheeks and lips
Oral cavity is free of open sores, ulcers, wounds, and lesions
Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
Is qualified to participate in the opinion of the Investigator, or designee

Who cannot join

Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
Has facial hair that interferes with the adhesion of the skin barrier pads
Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles
Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
Has a known or stated allergy to adhesives
Currently is participating in any clinical study which may affect the performance of the device

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Community Regional Medical Center
Fresno, California, 93701
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210
Legacy Emanuel Hospital & Health Center
Portland, Oregon, 97227

Other trials in United States

About this study

Official title: Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

Read the detailed description

This is a multiple site prospective assessment of the study product in ICU settings. The study is comprised of each intubated subject wearing one study product until the device either needs to be changed or is no longer required by the subject. The study product is designed to hold a standard or subglottic ET tube and help reduce the potential for occlusion (blockage) of the tube.

Conditions: Intubation
Being tested: New oral endotracheal tube holder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New oral endotracheal tube holderDevice
The single arm study product is designed to hold a standard or subglottic ET tube.

Study groups in NCT03328182
Study group	Role	What they receive
New oral endotracheal tube holder	Experimental	Single Study Product Arm Receives: Device: New oral endotracheal tube holder

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Acceptability With Study Product
The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable
Measured: At product removal (maximum 29 days of patient wearing product)
Usability of Study Product
The usability of the study product at application and at removal.
Measured: At application and product removal (maximum 29 days of patient wearing product)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 201715 Jun 2018

First posted1 Nov 2017
Study start23 Oct 2017
Primary completion8 Jun 2018
Study completion15 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for IntubationStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03328182
Sponsor's protocol ID: 5855-I
Status last verified: Apr 2019
First submitted: 16 Oct 2017
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Buckley JC, Brown AP, Shin JS, Rogers KM, Hoftman NN. A Comparison of the Haider Tube-Guard(R) Endotracheal Tube Holder Versus Adhesive Tape to Determine if This Novel Device Can Reduce Endotracheal Tube Movement and Prevent Unplanned Extubation. Anesth Analg. 2016 May;122(5):1439-43. doi: 10.1213/ANE.0000000000001222.
PubMed 26983051
Mohammed, H & Hassan, M. (2015). Endotracheal tube securements: Effectiveness of three techniques among orally intubated patients. Egyptian Journal of Chest Diseases and Tuberculosis 64:183-196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube
ClinicalTrials.gov ID: NCT03328182
Acronym / sponsor ID: 5855-I
Conditions: Intubation
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Hollister IncorporatedIndustry (pharma, biotech, devices)
Study start: 23 Oct 2017 (actual)
Primary completion: 8 Jun 2018 (actual)
Study completion: 15 Jun 2018 (actual)
First posted: 1 Nov 2017 (actual)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
New oral endotracheal tube holder	Experimental	Device: New oral endotracheal tube holderSingle Study Product Arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
Requires the use of a bite block per the hospital's standard of care
Has intact skin on and around application site, including cheeks and lips
Oral cavity is free of open sores, ulcers, wounds, and lesions
Subject or Legal Authorized representative (LAR) able to provide informed consent for the study

Key exclusion criteria (6 listed)

Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
Has facial hair that interferes with the adhesion of the skin barrier pads
Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles
Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
Has a known or stated allergy to adhesives

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
New oral endotracheal tube holderThe single arm study product is designed to hold a standard or subglottic ET tube.	Device	New oral endotracheal tube holder

Primary outcome

Overall Acceptability With Study Product
Time frame: At product removal (maximum 29 days of patient wearing product)
The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable
Usability of Study Product
Time frame: At application and product removal (maximum 29 days of patient wearing product)
The usability of the study product at application and at removal.

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Oral Endotracheal Tube Holder	34	30

Primary outcome: Overall Acceptability With Study Product

Time frame: At product removal (maximum 29 days of patient wearing product). Count of participants. Unit: Participants

Measure	New Oral Endotracheal Tube Holder n = 30
Very Acceptable	13
Acceptable	15
Neither acceptable nor acceptable	0
Unacceptable	2
Very Unacceptable	0

Primary outcome: Usability of Study Product

Time frame: At application and product removal (maximum 29 days of patient wearing product). Count of participants. Unit: Participants

Measure	New Oral Endotracheal Tube Holder n = 30
Ease of application: Very easy to apply	20
Ease of application: Easy to apply	8
Ease of application: Neither easy nor difficult to apply	1
Ease of application: Difficult to apply	1
Ease of application: Very difficult to apply	0
Ease of application: Not Applicable	0
Ease of removal: Very easy to apply	18
Ease of removal: Easy to apply	7

Adverse events

Time frame: maximum 29 days of patient wearing product. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Oral Endotracheal Tube Holder	3 of 30 (10%)	1 of 30 (3.3%)	1 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26983051Buckley JC, Brown AP, Shin JS, Rogers KM, Hoftman NN. A Comparison of the Haider Tube-Guard(R) Endotracheal Tube Holder Versus Adhesive Tape to Determine if This Novel Device Can Reduce Endotracheal Tube Movement and Prevent Unplanned Extubation. Anesth Analg. 2016 May;122(5):1439-43. doi: 10.1213/ANE.0000000000001222.
BackgroundMohammed, H & Hassan, M. (2015). Endotracheal tube securements: Effectiveness of three techniques among orally intubated patients. Egyptian Journal of Chest Diseases and Tuberculosis 64:183-196
Individual participant dataSharing planned: No

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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.

Laura Vander Werff, MD principal investigator

Legacy Mount Hood Medical Center

Brian Young, MD principal investigator

1. Legacy Emanuel Hospital & Health Center 2. Legacy Good Samaritan Medical Center

Arash Afshinnik, MD principal investigator

Community Regional Medical Center

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing New oral endotracheal tube holder in people with Intubation, run by Hollister Incorporated at 4 sites in United States.

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Acceptability With Study Product (time frame: At product removal (maximum 29 days of patient wearing product)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03328182, which also lists 2 linked publications.

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 5 Jul 2019.