Superior Laryngeal Nerve Block For Awake Endotracheal Intubation Study

Difficult Intubation Clinical Trial

Official title:

Superior Laryngeal Nerve Block For Airway Anesthesia Efficacy Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01848548
• Other study ID #: SLN Airway Trial
• Status: Terminated
• Phase: N/A
• First received: February 19, 2013
• Last updated: November 1, 2017
• Start date: April 2013
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Anesthesia
• Awake Endotracheal Intubation
• Difficult Intubation

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	During the intubation the lowest mean arterial blood pressure (MAP)		Immediate Perioperative Period
Other	The lowest heart rate(HR) during intubation		Immediate Perioperative Period
Other	The lowest respiratory rate during the intubation		Immediate Perioperative Period
Primary	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	Time to placement of block		Immediate Perioperative Period