Endotracheal Tube Holder and Bite Guard Research
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | January 2016 |
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.
Specifically, this new device will be tested among 1) neurosurgical patients lying face
upward, 2) thoracic surgery patients lying on their side, and 3) orthopedic and
neurosurgical spine surgery patients lying face downward.
bite guard when compared with the current standard of care, tape and an oral airway.
Specifically, this new device will be tested among 1) neurosurgical patients lying face
upward, 2) thoracic surgery patients lying on their side, and 3) orthopedic and
neurosurgical spine surgery patients lying face downward.
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 three 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 1) neurosurgical patients in the supine position, 2) thoracic
surgery patients in the lateral position, and 3) surgery patients in the prone position. We
hypothesize the device will be superior to the standard of care in both efficacy and patient
comfort.
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 three 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 1) neurosurgical patients in the supine position, 2) thoracic
surgery patients in the lateral position, and 3) surgery patients in the prone position. We
hypothesize the device will be superior to the standard of care in both efficacy and patient
comfort.
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.
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