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.
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
- Type of treatment
- Medical device, Surgery or procedure
- 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
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 group | Role | What they receive |
|---|---|---|
| ETT holder and bite guard | Experimental | Participants 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.
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)
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.
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)
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.
- First posted27 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionJan 2016
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 SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nir Hoftman, M.D., University of California, Los Angeles
- Investigators
- Nir Hoftman, MD, Principal investigator, University of California, Los Angeles
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02347488
- Acronym / sponsor ID
- 14-001836
- Conditions
- Surgery, Anesthesia
- Keywords
- ETT Holder, bite guard, airway, endotracheal tube
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 4 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ETT holder and bite guard | Experimental | Device: Haider ETT Tube Holder and Bite Guard, Procedure: TapeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Haider ETT Tube Holder and Bite GuardAlso: ETT Tube Holder and Bite BlockSurgery 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. | Device | ETT holder and bite guard |
| TapeSurgery 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. | Procedure or surgery | ETT holder and bite guard |
Primary outcome
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).
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.
3 secondary outcomes
Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device
Time frame: Immediately after surgery and 1-3 days following surgery, before discharge.
Clinically Significant Movement
Time frame: 5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)
Potentially High Extubation Risk
Time frame: 5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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.
Nir Hoftman, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
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.