Endotracheal Tube Holder and Bite Guard Research
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ETT holder and bite guard 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. |
Device: Haider ETT Tube Holder and Bite Guard
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.
Other Names:
Procedure: Tape
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.
|
Outcome Measures
Primary Outcome Measures
- Change in ETT Position [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.
Secondary Outcome Measures
- Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device [Immediately after surgery and 1-3 days following surgery, before discharge.]
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.
- Clinically Significant Movement [5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)]
Number of participants experiencing ETT movement >1cm under each fixation technique
- Potentially High Extubation Risk [5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)]
Number of participants experiencing ETT movement >4cm under each fixation technique
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: Nir Hoftman, MD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-001836
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tape, Followed by ETT Holder and Bite Guard |
|---|---|
| Arm/Group Description | Tape: Surgery patients had 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. Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery. |
| Period Title: Overall Study | |
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Tape, Followed by ETT Holder and Bite Guard |
|---|---|
| Arm/Group Description | Tape: Surgery patients had 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. Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery. |
| Overall Participants | 30 |
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
55.4
|
| Sex: Female, Male (Count of Participants) | |
| Female |
16
53.3%
|
| Male |
14
46.7%
|
| Region of Enrollment (participants) [Number] | |
| United States |
30
100%
|
Outcome Measures
| Title | Change in ETT Position |
|---|---|
| Description | 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. |
| Time Frame | 5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adhesive Tape | Haider ETT Tube Holder |
|---|---|---|
| Arm/Group Description | Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard. | Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard. |
| Measure Participants | 30 | 30 |
| Mean (Standard Deviation) [centimeters] |
3.4
(1.8)
|
0.3
(0.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Adhesive Tape, Haider ETT Tube Holder |
|---|---|---|
| Comments | Average displacement difference in cm, tape vs. tube-holder. 17 participants was the estimated enrollment needed to detect a difference of 1 SD from the mean between the 2 fixation techniques at 80% power; additional enrollment was included to increase the power of results and to include a larger variety of patients undergoing different surgical procedures. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.1 | |
| Confidence Interval |
(2-Sided) 95% 2.88 to 3.32 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 1.8 |
|
| Estimation Comments | ||
| Title | Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device |
|---|---|
| Description | 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. |
| Time Frame | Immediately after surgery and 1-3 days following surgery, before discharge. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 29 patients returned the survey (one patient was aphasic post-op and could not compete the survey) |
| Arm/Group Title | Tape, Followed by ETT Holder and Bite Guard |
|---|---|
| Arm/Group Description | Tape: Surgery patients had 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. Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery. |
| Measure Participants | 29 |
| Count of Participants [Participants] |
2
6.7%
|
| Title | Clinically Significant Movement |
|---|---|
| Description | Number of participants experiencing ETT movement >1cm under each fixation technique |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adhesive Tape | Haider ETT Tube Holder |
|---|---|---|
| Arm/Group Description | Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard. | Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard. |
| Measure Participants | 30 | 30 |
| Count of Participants [Participants] |
29
96.7%
|
1
NaN
|
| Title | Potentially High Extubation Risk |
|---|---|
| Description | Number of participants experiencing ETT movement >4cm under each fixation technique |
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Adhesive Tape | Haider ETT Tube Holder |
|---|---|---|
| Arm/Group Description | Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard. | Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard. |
| Measure Participants | 30 | 30 |
| Count of Participants [Participants] |
9
30%
|
0
NaN
|
Adverse Events
| Time Frame | Immediately after surgery and up to 1-3 days following surgery, before discharge. | |
|---|---|---|
| Adverse Event Reporting Description | Unfavorable findings were recorded as adverse events in this study only if severe, unexpected, or considered to have been attributable to use of the study device. | |
| Arm/Group Title | Tape, Followed by ETT Holder and Bite Guard | |
| Arm/Group Description | Tape: Surgery patients had 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. Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery. Adverse events were not reported "per arm" because surgery patients were assessed for adverse events after experiencing both methods. | |
All Cause Mortality |
||
| Tape, Followed by ETT Holder and Bite Guard | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Tape, Followed by ETT Holder and Bite Guard | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Tape, Followed by ETT Holder and Bite Guard | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/30 (6.7%) | |
| Gastrointestinal disorders | ||
| Mild discomfort of the gum | 1/30 (3.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| minor abrasion of the tongue frenulum | 1/30 (3.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nir Nahum Hoftman, MD |
|---|---|
| Organization | UCLA Department of Anesthesiology |
| Phone | 310-267-8679 |
| nhoftman@mednet.ucla.edu |
- 14-001836