Endotracheal Tube Holder and Bite Guard Research

Surgery Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347488
• Other study ID #: 14-001836
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2015
• Last updated: February 3, 2016
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	University of California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ETT Position	The ability of the securing device to resist endotracheal tube dislodgement under axial strain for patients in the prone and supine positions will be measured. The endotracheal tube, once secured with either tape or the Haider airway device, will encounter an axial force that would simulate the endotracheal tube being pulled from the mouth. The force will be increased until a maximal force is reached (40N) or until the endotracheal tube tip moves by more than 5cm from its original location. The change in position, measured in cm, will be recorded.	5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).	No
Primary	Balloon Cuff Herniation at Inflation	The ability of the securing device to resist dislodgement of the bronchial blue cuff of a double lumen endotracheal tube from its correct location (left mainstem bronchus) to an incorrect location (trachea) in patients in the lateral position will be measured. Under bronchoscopic real time visualization the bronchial balloon cuff will be inflated with increasing volume of air. A maximum of 8cc of air will be inflated into the balloon. The volume of air at which the cuff herniates out into the trachea, measured in cubic centimeters, will be recorded. If the cuff does not herniate, this will be recorded as well.	5 minutes after the double-lumen endotracheal tube is positioned (which occurs immediately after intubation).	No
Secondary	Presence of any irritation of minor injury to the face and oral structures	The patient will be examined after surgery (both immediately after surgery and at the end of the recovery room period) to determine if the patient has suffered any irritation or minor injury to the face and oral structures. The patient will be 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.	Immediately after surgery and 1-3 days following surgery, before discharge.	No