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Superior Laryngeal Nerve Block For Awake Endotracheal Intubation Study

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ClinicalTrials.gov Identifier: NCT01848548
Recruitment Status : Terminated (Unable to continue recruit subjects)
First Posted : May 7, 2013
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment
Awake Endotracheal Intubation Difficult Intubation Airway Anesthesia Procedure: Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Superior Laryngeal Nerve Block For Airway Anesthesia Efficacy Study
Study Start Date : April 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

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.




Primary Outcome Measures :
  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 [ Time Frame: Immediate Perioperative period ]

Secondary Outcome Measures :
  1. Time to placement of block [ Time Frame: Immediate Perioperative Period ]

Other Outcome Measures:
  1. During the intubation the lowest mean arterial blood pressure (MAP) [ Time Frame: Immediate Perioperative Period ]
  2. The lowest heart rate(HR) during intubation [ Time Frame: Immediate Perioperative Period ]
  3. The lowest respiratory rate during the intubation [ Time Frame: Immediate Perioperative Period ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Scheduled Surgery Patients who require an awake intubation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848548


Locations
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United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Scott Miller, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01848548     History of Changes
Other Study ID Numbers: SLN Airway Trial
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No