Superior Laryngeal Nerve Block For Awake Endotracheal Intubation Study

Superior Laryngeal Nerve Block For Airway Anesthesia Efficacy Study

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

Study Overview

• Status: Terminated
• Conditions: Difficult Intubation; Awake Endotracheal Intubation; Airway Anesthesia
• Intervention / Treatment: Procedure: Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Scheduled Surgery Patients who require an awake intubation

Description

Inclusion Criteria

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

Exclusion Criteria

1. Allergy to lidocaine
2. Emergent operative case
3. Therapeutic anticoagulation
4. Mouth opening less than 2 cm

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Assessment of Superior Laryngeal Nerve Block Technique	Procedure: Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Time to placement of block	Immediate Perioperative Period

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Scott Miller, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SLN Airway Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No