Superior Laryngeal Nerve Block For Awake Endotracheal Intubation Study

NCT01848548 | Terminated

• 1 other identifier: SLN Airway Trial
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Awake tracheal intubation is the standard management for patients as risk for airway compromise. It is also commonly done in cases where there is significant cervical spine pathology i.e. cervical myelopathy or instability. The anesthetic technique used for the awake intubation is crucial to the patient's safety. One of the most important aspects of the anesthetic technique is airway anesthesia prior to placement of an endotracheal tube. The superior laryngeal nerve is responsible for mediating the cough reflex around the vocal cords. The investigators have developed an approach to reliably block the superior laryngeal nerve by injecting local anesthetic near the nerve in a unique approach. Injecting local anesthetic into or through the thyrohyoid membrane will effectively block the superior laryngeal nerve

Conditions

Awake Endotracheal Intubation; Difficult Intubation; Airway Anesthesia

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is to assess the efficacy of blocking the superior laryngeal nerve by using cough at the vocal cords on a 4 point scale

  Immediate Perioperative period

Secondary Outcomes (1)

• Time to placement of block

  Immediate Perioperative Period

Other Outcomes (3)

• During the intubation the lowest mean arterial blood pressure (MAP)

  Immediate Perioperative Period

• The lowest heart rate(HR) during intubation

  Immediate Perioperative Period

• The lowest respiratory rate during the intubation

  Immediate Perioperative Period

Study Arms (1)

Assessment of Superior Laryngeal Nerve Block Technique

Procedure: Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark

Interventions

Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark PROCEDURE

The needle is introduced just lateral to midline above the thyroid notch in a slightly medial direction so as to enter the thyrohyoid membrane, and inserted about 1-1.5 cm. Three milliliters of 2% lidocaine is injected.

Assessment of Superior Laryngeal Nerve Block Technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Scheduled Surgery Patients who require an awake intubation

You may qualify if:

• Patients between the ages of 18-80 requiring an awake intubation for endotracheal intubation.
• Ability to speak and understand English

You may not qualify if:

• Allergy to lidocaine
• Emergent operative case
• Therapeutic anticoagulation
• Mouth opening less than 2 cm

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Scott Miller, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: May 7, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)