Respiratory DepressionNCT02760927

Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes

A study testing Endotracheal Tube Fastener in people with Respiratory Depression and Respiratory Failure, run by Hollister Incorporated at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Depression, Respiratory Failure, Ventilatory Depression
What is being tested?: Endotracheal Tube Fastener
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 3 sitesUnited States
Study dates: Mar 2016to May 2016
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 requires oral tracheal intubation
Has intact skin on application site
Is qualified to participate in the opinion of the Investigator including the requirement for endotracheal tube with subglottic suction

Who cannot join

Has an existing neck injury
Has protruding upper teeth, is without teeth or is unable to wear upper dentures
Has facial hair
Has clinically significant skin damage, condition or disease on the application site which may contraindicate participation
Has a known or stated allergy to adhesive bandages, or any of the product types being tested
Uses of topical drugs, lotions, creams or oils on the application site
Is participating in any clinical testing which may affect performance of this device
AnchorFast Guard Oral Endotracheal Tube Fastener does not fit subject's face

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Legacy Mt Hood
Gresham, Oregon, 97030
Legacy Good Samaritan
Portland, Oregon, 97210
Legacy Salmon Creek Medical Center
Vancouver, Washington, 98686

Other trials in United States

About this study

Official title: Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction

Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction

Read the detailed description

Endotracheal intubation is the trans laryngeal placement of a tube into the trachea via the nose or mouth. Subglottic suctioning, during endotracheal tube securement, is important for mechanically-ventilated patients to allow for the clearance of secretions that may accumulate during intubation. This protocol examines an enhancement to the current AnchorFast Guard device in order for the device to hold a subglottic suctioning lumen in addition to the intubation tube.

Conditions: Respiratory Depression, Respiratory Failure, Ventilatory Depression
Being tested: Endotracheal Tube Fastener
Medical subject headings: Respiratory Insufficiency

What participants receive

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

Endotracheal Tube FastenerDevice
Also called AnchorFast Guard Oral Endotracheal Tube Fastener
The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device.

Study groups in NCT02760927
Study group	Role	What they receive
Endotracheal Tube Fastener	Experimental	The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube. Receives: Device: Endotracheal Tube Fastener

What is being measured

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

Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen
Assessed by the proportion of yes/no researcher responses
Measured: Typical wear time of endotracheal tube fastener up to one week
Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve
Assessed by the proportion of researcher responses that equal agree (4) plus strongly agree (5) on a five point scale that includes strongly disagree (1) disagree (2) and no opinion (3)
Measured: Typical wear time of endotracheal tube fastener up to one week
Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract
Assessed by the proportion of yes/no researcher responses
Measured: Typical wear time of endotracheal tube fastener up to one week
Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
Assessed by the proportion of yes/no researcher responses
Measured: Typical wear time of endotracheal tube fastener up to one week
Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
Assessed by the proportion of yes/no researcher responses
Measured: Typical wear time of endotracheal tube fastener up to one week

Timeline

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

Mar 2016May 2016

First posted4 May 2016 (estimated)
Study startMar 2016
Primary completionApr 2016
Study completionMay 2016

Why it stopped: Study product will not be commercialized.

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.
Other trials for Respiratory DepressionStudies 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02760927
Sponsor's protocol ID: 5799-I
Status last verified: Aug 2018
First submitted: 18 Apr 2016
Last updated: 6 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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?

See locations

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All Respiratory Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction
ClinicalTrials.gov ID: NCT02760927
Acronym / sponsor ID: 5799-I
Conditions: Respiratory Depression, Respiratory Failure, Ventilatory Depression
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study product will not be commercialized.
Enrolment: 4 participants (actual)
Lead sponsor: Hollister IncorporatedIndustry (pharma, biotech, devices)
Study start: Mar 2016
Primary completion: Apr 2016 (actual)
Study completion: May 2016 (actual)
First posted: 4 May 2016 (estimated)
Results: Posted 6 Sep 2018

Clinical summary

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

Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction

Detailed description

Study design

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

Arm	Type	Receives
Endotracheal Tube Fastener	Experimental	Device: Endotracheal Tube FastenerThe intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube.

Who may qualify

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

Key inclusion criteria (3 listed)

Is 18 years of age or older and requires oral tracheal intubation
Has intact skin on application site
Is qualified to participate in the opinion of the Investigator including the requirement for endotracheal tube with subglottic suction

Key exclusion criteria (8 listed)

Has an existing neck injury
Has protruding upper teeth, is without teeth or is unable to wear upper dentures
Has facial hair
Has clinically significant skin damage, condition or disease on the application site which may contraindicate participation
Has a known or stated allergy to adhesive bandages, or any of the product types being tested

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
Endotracheal Tube FastenerAlso: AnchorFast Guard Oral Endotracheal Tube FastenerThe AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device.	Device	Endotracheal Tube Fastener

Primary outcome

Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen
Time frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve
Time frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of researcher responses that equal agree (4) plus strongly agree (5) on a five point scale that includes strongly disagree (1) disagree (2) and no opinion (3)
Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract
Time frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen
Time frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning
Time frame: Typical wear time of endotracheal tube fastener up to one week
Assessed by the proportion of yes/no researcher responses

Results and safety

Results posted to the registry on 6 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Endotracheal Tube Fastener	4	3

Primary outcome: Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen

Time frame: Typical wear time of endotracheal tube fastener up to one week. Count of participants. Unit: Participants

Measure	Endotracheal Tube Fastener n = 4
Value	4

Population analysed: Intent-to-Treat

Primary outcome: Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve

Time frame: Typical wear time of endotracheal tube fastener up to one week. Count of participants. Unit: Participants

Measure	Endotracheal Tube Fastener n = 4
Strongly Agree \| Agree	3
Strongly Disagree \| Disagree \| No opinion	1

Population analysed: Intent-to-Treat

Primary outcome: Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract

Time frame: Typical wear time of endotracheal tube fastener up to one week. Count of participants. Unit: Participants

Measure	Endotracheal Tube Fastener n = 4
Yes	3
No (Thick secretions)	1

Population analysed: Intent-to-Treat

Primary outcome: Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen

Time frame: Typical wear time of endotracheal tube fastener up to one week. Count of participants. Unit: Participants

Measure	Endotracheal Tube Fastener n = 4
Yes	3
No (Removed with thick secretions)	1

Population analysed: Intent-to-Treat

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endotracheal Tube Fastener	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Paul Newton, JD study chair

Legacy Research Institute IRB

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

Questions about this trial

What is this clinical trial studying?

A study testing Endotracheal Tube Fastener in people with Respiratory Depression and Respiratory Failure, run by Hollister Incorporated at 3 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 6 Sep 2018). 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?

Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen (time frame: Typical wear time of endotracheal tube fastener up to one week). The study lists 5 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 NCT02760927.

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 6 Sep 2018.