Respiratory InsufficiencyNCT01651260
Assessment of an Endotracheal Tube Securement Device
A study testing Experimental ET Tube Securement Device in people with Respiratory Insufficiency, run by Hollister Incorporated at 5 sites in United States.
Trial summary
Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Experimental ET Tube Securement Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2012to Feb 2013
- 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; male or female and requiring oral tracheal intubation.
- Has intact skin on application site.
- Willingly signs or their authorized representative willingly signs the Informed Consent.
- Is qualified to participate in the opinion of the Investigator.
Who cannot join
- Has an existing neck injury.
- Has protruding upper teeth, without teeth or is unable to wear upper dentures.
- Has facial hair.
- Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer.
- Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site.
- Has a known or stated allergy to adhesive bandages, or any of the product types being tested.
Show all 10Show fewer
- Uses of topical drugs on the application site.
- Uses lotions, creams or oils on the application site.
- Currently is participating in any clinical testing which may affect performance of this device.
- Has been previously intubated with skin irritation or pressure sores surrounding the mouth.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Hartford Hospital
Hartford, Connecticut, 06102
Legacy Good Samaritan
Portland, Oregon, 97210
St. Joseph's Hospitals
Tampa, Florida, 33607
Legacy Salmon Creek Medical Center
Vancouver, Washington, 98686
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.
Read the detailed description
This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.
- Conditions
- Respiratory Insufficiency
- Being tested
- Experimental ET Tube Securement Device
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental ET Tube Securement DeviceOther
Also called AnchorFast Guard® ET tube securement device
Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal (ET) tube securement device | Other | Single arm study evaluated an experimental ET tube securement device with a bite block. Receives: Other: Experimental ET Tube Securement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use
Number of participants with damage of ET tube and Number of participants with occlusion of ET tube
Measured: 14 days
Secondary outcomes (1)
Ease of Use
Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);
Measured: Between 1 - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 InsufficiencyStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Konz, PhD, Study chair, Hollister Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651260
- Sponsor's protocol ID
- 5156-I
- Status last verified
- Feb 2016
- First submitted
- 16 Jul 2012
- Last updated
- 23 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device
- ClinicalTrials.gov ID
- NCT01651260
- Acronym / sponsor ID
- 5156-I
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Posted 28 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.
Detailed description
This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.
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 (ET) tube securement device | Other | Other: Experimental ET Tube Securement DeviceSingle arm study evaluated an experimental ET tube securement device with a bite block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is 18 years of age or older; male or female and requiring oral tracheal intubation.
- Has intact skin on application site.
- Willingly signs or their authorized representative willingly signs the Informed Consent.
- Is qualified to participate in the opinion of the Investigator.
Key exclusion criteria (10 listed)
- Has an existing neck injury.
- Has protruding upper teeth, without teeth or is unable to wear upper dentures.
- Has facial hair.
- Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer.
- Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site.
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 |
|---|---|---|
| Experimental ET Tube Securement DeviceAlso: AnchorFast Guard® ET tube securement deviceExperimental Hollister device with bite block was substituted for standard-of-care device during the study period. | Other | Endotracheal (ET) tube securement device |
Primary outcome
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use
Time frame: 14 days
Number of participants with damage of ET tube and Number of participants with occlusion of ET tube
1 secondary outcome
Ease of Use
Time frame: Between 1 - 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- 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.
Elizabeth Konz, PhD study chair
Hollister Incorporated
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental ET Tube Securement Device in people with Respiratory Insufficiency, run by Hollister Incorporated at 5 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 4 inclusion and 10 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 28 Oct 2015). 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?
Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use (time frame: 14 days). 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 23 Mar 2016.