Endotracheal Tube Holder and Bite Guard Research

NCT02347488 | Completed Phase 4 Results

• 1 other identifier: 14-001836
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Anesthesia

Keywords

ETT Holder, bite guard, airway, endotracheal tube

Outcome Measures

Primary Outcomes (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.

  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

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

• 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)

• 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)

Study Arms (1)

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.

Device: Haider ETT Tube Holder and Bite Guard; Procedure: Tape

Interventions

Haider ETT Tube Holder and Bite Guard DEVICE

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.

Also known as: ETT Tube Holder and Bite Block

ETT holder and bite guard

Tape PROCEDURE

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.

ETT holder and bite guard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Mouth Protectors

Intervention Hierarchy (Ancestors)

Preventive Dentistry; Dentistry; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Nir Nahum Hoftman, MD
• Organization: UCLA Department of Anesthesiology

nhoftman@mednet.ucla.edu

310-267-8679

Study Officials

• Nir Hoftman, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Clinical Professor

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 17, 2017
• Results First Posted: January 4, 2017

Record last verified: 2017-03

Locations

US (1)