Mechanical Ventilation ComplicationETTSNCT03760510

Endotracheal Tube Securement Study

A study testing Tube Fastener and Adhesive Tape in people with Mechanical Ventilation Complication, run by Vanderbilt University Medical Center at 1 site 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

To evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic, randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube fastener on complications including lip ulcers, facial skin tears, endotracheal tube dislodgement, and ventilator associated… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Mechanical Ventilation Complication
What is being tested?: Tube Fastener and Adhesive Tape
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 1 siteUnited States
Study dates: 17 May 2017to 30 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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient intubated prior to admission to the MICU and the intubation time was less than 12 hours from the time of admission
Patients intubated in the MICU for greater than 24 hours

Who cannot join

intubated greater than 12 hours prior to admission to the MICU
presence of oral mucosa or facial skin breakdown prior to enrollment
required nasotracheal intubation,
had a documented allergy to tape
pregnant
prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study

Read the detailed description

Background: The optimal securement method of endotracheal tubes is unknown, but should provide adequate security while minimizing complications. This study tests the hypothesis that use of an endotracheal tube fastener would reduce complications among critically ill adults undergoing endotracheal intubation. This hypothesis will be tested in a pragmatic, single center, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.

Conditions: Mechanical Ventilation Complication
Being tested: Tube Fastener, Adhesive Tape
Keywords: endotracheal tube, tube fastener, facial skin tear, lip ulcer, endotracheal tube dislodgement

What participants receive

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

Tube FastenerDevice
Also called Hollister AnchorFast
Endotrachel tube secured with tube fastener
Adhesive TapeDevice
Endotracheal tube secured with adhesive tape.

Study groups in NCT03760510
Study group	Role	What they receive
Adhesive Tape	Experimental	Patients in adhesive tape arm had endotracheal tube secured with adhesive tape Receives: Device: Adhesive Tape
Tube Fastener	Experimental	Patients in the tube fastener arm had endotrachel tube secured with tube fastener Receives: Device: Tube Fastener

What is being measured

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

Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation
Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation
Measured: 48 hours post extubation up to 3 months

Secondary outcomes (3)

Number of Participants With Lip Ulcers
Presence of lip ulcer
Measured: 48 hours post extubation up to 3 months
Number of Participants With Facial Skin Tear
presence of facial skin tear
Measured: 48 hours post extubation up to 3 months
Number of Participants With Ett Dislodgement
frequency of ett dislodgement
Measured: duration of intubation up to 3 months

Timeline

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

17 May 201730 Jun 2018

First posted30 Nov 2018
Study start17 May 2017
Primary completion14 Apr 2018
Study completion30 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 (1)Papers the sponsor has linked to this study.
Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: The endotracheal tube securement study was a pragmatic, single center, open-label, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister AnchorFast Guard) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
Masking: None (open label)
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03760510
Sponsor's protocol ID: IRB #170596
Acronym: ETTS
Status last verified: Jul 2019
First submitted: 26 Nov 2018
Last updated: 10 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: publication in a peer-reviewed medical journal

Publications

Landsperger JS, Byram JM, Lloyd BD, Rice TW; Pragmatic Critical Care Research Group. The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial. Crit Care. 2019 May 7;23(1):161. doi: 10.1186/s13054-019-2440-7.
PubMed 31064406

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 Mechanical Ventilation Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study
ClinicalTrials.gov ID: NCT03760510
Acronym / sponsor ID: ETTS / IRB #170596
Conditions: Mechanical Ventilation Complication
Keywords: endotracheal tube, tube fastener, facial skin tear, lip ulcer, endotracheal tube dislodgement
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 17 May 2017 (actual)
Primary completion: 14 Apr 2018 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 30 Nov 2018 (actual)
Results: Posted 10 Jul 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The endotracheal tube securement study was a pragmatic, single center, open-label, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister AnchorFast Guard) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.

Arm	Type	Receives
Adhesive Tape	Experimental	Device: Adhesive TapePatients in adhesive tape arm had endotracheal tube secured with adhesive tape
Tube Fastener	Experimental	Device: Tube FastenerPatients in the tube fastener arm had endotrachel tube secured with tube fastener

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient intubated prior to admission to the MICU and the intubation time was less than 12 hours from the time of admission
Patients intubated in the MICU for greater than 24 hours

Key exclusion criteria (6 listed)

intubated greater than 12 hours prior to admission to the MICU
presence of oral mucosa or facial skin breakdown prior to enrollment
required nasotracheal intubation,
had a documented allergy to tape
pregnant

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
Tube FastenerAlso: Hollister AnchorFastEndotrachel tube secured with tube fastener	Device	Tube Fastener
Adhesive TapeEndotracheal tube secured with adhesive tape.	Device	Adhesive Tape

Primary outcome

Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation
Time frame: 48 hours post extubation up to 3 months
Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation

3 secondary outcomes

Number of Participants With Lip Ulcers
Time frame: 48 hours post extubation up to 3 months
Number of Participants With Facial Skin Tear
Time frame: 48 hours post extubation up to 3 months
Number of Participants With Ett Dislodgement
Time frame: duration of intubation up to 3 months

Results and safety

Results posted to the registry on 10 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
Adhesive Tape	250	145
Tube Fastener	250	153

Primary outcome: Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation

Time frame: 48 hours post extubation up to 3 months. Mean (95% Confidence Interval). Unit: events per 1000 ventilator days

Measure	Adhesive Tape n = 145	Tube Fastener n = 153
Value	52.6 (47.4 to 57.8)	22.0 (16.3 to 27.7)

Population analysed: Enrolled patients ventilated for at least 24 hours who had primary outcome data

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Until 48 hours after extubation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adhesive Tape	2 of 145 (1.4%)	0 of 145 (0%)	54 of 145
Tube Fastener	2 of 153 (1.3%)	0 of 153 (0%)	57 of 153

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31064406Landsperger JS, Byram JM, Lloyd BD, Rice TW; Pragmatic Critical Care Research Group. The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial. Crit Care. 2019 May 7;23(1):161. doi: 10.1186/s13054-019-2440-7.
Individual participant dataSharing planned: No. publication in a peer-reviewed medical journal

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Not yet recruitingObservational study
Enteral Feeding in Mechanically Ventilated Children
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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.

Janna Landsperger, ACNP principal investigator

Vanderbilt University Medical Center

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

Questions about this trial

What is this clinical trial studying?

A study testing Tube Fastener and Adhesive Tape in people with Mechanical Ventilation Complication, run by Vanderbilt University Medical Center at 1 site 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 2 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 10 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 1 site 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 10 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?

Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation (time frame: 48 hours post extubation up to 3 months). 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 NCT03760510, which also lists 1 linked publication.

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 10 Jul 2019; AzTrials last refreshed its copy on 28 Oct 2026.