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SurgeryPhase 4NCT02347488

Endotracheal Tube Holder and Bite Guard Research

A Phase 4 study testing Haider ETT Tube Holder and Bite Guard and Tape in people with Surgery and Anesthesia, run by University of California, Los Angeles 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

This study aims to test the effectiveness of a novel combined endotracheal tube holder and bite guard when compared with the current standard of care, tape and an oral airway. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery, Anesthesia
What is being tested?
Haider ETT Tube Holder and Bite Guard and Tape
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Feb 2015to Jan 2016
Phase
Phase 4
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

  • Age ≥ 18 years
  • General anesthesia requiring oral endotracheal intubation in the prone position for the duration of surgery (head secured in a foam head holder, horseshoe frame, or Mayfield pins).
  • General anesthesia for neurosurgery requiring oral endotracheal intubation, supine or slight lateral bump position for the duration of surgery. (Special emphasis will be placed on including patients who will undergo motor evoked potentials, and thus will not be paralyzed during the surgery).
  • General anesthesia requiring oral endotracheal intubation with a left sided double-lumen endotracheal tube for lung isolation, lateral position for the duration of surgery.

Who cannot join

  • Dentition issues (loose teeth, missing teeth)
  • Temporomandibular joint disease
  • Maxillofacial abnormalities (deformities of the jaw, lips, tongue)
  • Surgical procedures involving the teeth, lips, jaw
  • History of asthma or bronchospasm
  • Immunosuppression.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Testing a Novel Combined Endotracheal Tube Holder and Bite Guard in Neurosurgical Patients, Thoracic Surgery Patients, and Orthopedic and Neurosurgical Spine Surgery Patients.

This study aims to test the effectiveness of a novel combined endotracheal tube holder and bite guard when compared with the current standard of care, tape and an oral airway.

Read the detailed description

Endotracheal tubes (ETT) are secured during surgery and ICU care so that they are not accidentally removed from the airway. The position of the tip of the ETT is important and must not vary much within the trachea. The standard technique for securing an ETT is to use tape to attach it to the upper lip and face. The technique is cheap and simple, but suffers from certain drawbacks. First, the upper lip is mobile and thus even when well secured, the tube can move within the trachea due to this mobility. Second, conditions on the face such as sweating, drooling, facial hair, skin flaking or breakdown, all interfere with the ability of the tape to adhere, thus reducing its efficacy. Furthermore, the tape itself can irritate and or injure the facial skin. The adhesive irritates skin and certain patients are allergic to these substances. Also, removing the tape can physically damage the skin, especially if the skin is vulnerable to sheer forces (such as elderly patients or patients on systemic steroids).

Patients that are intubated often need a bite block or bite guard inserted into their mouths. This serves two main purposes: 1) to prevent the patient from biting the ETT and occluding airflow, 2) to prevent the patient from biting their tongue, cheek, or lips causing injury. Furthermore, endoscopic procedures are often performed on intubated patients and thus a bite block is needed to protect the delicate instrument from being bitten and damaged. For these reasons, many providers will insert bite blocks into the mouths of intubated patients. Many such devices exist on the market, but the most commonly used is the Guedel oral airway. This device is actually designed to increase airway patency during mask ventilation, and long term use of this device as a bite block has been linked to numerous complications including: 1)tongue swelling, often compromising the airway patency, 2) tooth damage, and 3)lip injury. Because of these shortcomings, specific ETT bite blocks have been developed, and some of these even double as an ETT securing device. However, these are usually made of hard, stiff materials that in and of themselves can injure the delicate oral structures. In summation, no single device that both serves as an ergonomic ETT holder and bite block has been successfully developed and marketed, and therefore the standard of care remains tape plus an oral airway.

The Haider airway is a combination ETT holder-securing device and bite block. Made of soft silicone rubber, the device was engineered from the ground up to serve those purposes with safety and comfort in mind. The device is FDA approved and in a pre-marketing trials phase to determine the efficacy of the product in specific clinical scenarios. Our institution has been tasked with testing the device in clinical scenarios where tape + oral airway has been historically problematic. We plan to compare this new device to tape + oral airway, the current standard of care in neurosurgical patients in the supine position. We hypothesize the device will be superior to the standard of care in both efficacy and patient comfort.

Conditions
Surgery, Anesthesia
Being tested
Haider ETT Tube Holder and Bite Guard, Tape
Keywords
ETT Holder, bite guard, airway, endotracheal tube

What participants receive

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

  • Haider ETT Tube Holder and Bite GuardDevice

    Also called ETT Tube Holder and Bite Block

    Surgery patients will have endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard change in ETT tip position caused by traction up to 15N was measured prior to surgery.

  • TapeProcedure or surgery

    Surgery patients will have endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.

Study groups in NCT02347488
Study groupRoleWhat they receive
ETT holder and bite guardExperimentalParticipants will have endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of displacement, participants will have endotracheal tubes secured with a combined Haider ETT Tube Holder and Bite Guard.
Receives: Device: Haider ETT Tube Holder and Bite Guard; Procedure: Tape

What is being measured

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

  1. Change in ETT Position

    The ability of the securing device to resist endotracheal tube dislodgement under axial strain for patients in the supine position was measured. The endotracheal tube, once secured with either tape or the Haider airway device, encountered an axial force to simulate the endotracheal tube being pulled from the mouth. The force increased over approximately 5 seconds until the target of 15 N was reached or until the principal investigator deemed that the force be aborted to prevent possible tracheal extubation. The change in position, measured in cm, was recorded.

    Measured: 5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).

Secondary outcomes (3)
  1. Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device

    The patients were examined after surgery (both immediately after surgery and at the end of the recovery room period) to determine if the patient suffered any irritation or minor injury to the face and oral structures. The patients were asked to fill out a questionnaire after recovery with questions about their overall experience with specific relation to any irritation and/or minor trauma to their face, oral structures, throat, jaw, and temporomandibular joint.

    Measured: Immediately after surgery and 1-3 days following surgery, before discharge.

  2. Clinically Significant Movement

    Number of participants experiencing ETT movement >1cm under each fixation technique

    Measured: 5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)

  3. Potentially High Extubation Risk

    Number of participants experiencing ETT movement >4cm under each fixation technique

    Measured: 5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)

Timeline

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

  1. First posted27 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionAug 2015
  4. Study completionJan 2016

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02347488
Sponsor's protocol ID
14-001836
Status last verified
Mar 2017
First submitted
8 Jan 2015
Last updated
17 Apr 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Haider ETT Tube Holder and Bite Guard and Tape in people with Surgery and Anesthesia, run by University of California, Los Angeles 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 4 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 17 Apr 2017. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2017). 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?

Change in ETT Position (time frame: 5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).). 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 17 Apr 2017.

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