Awake Endotracheal IntubationNCT01848548
Superior Laryngeal Nerve Block For Awake Endotracheal Intubation Study
An observational study of Awake Endotracheal Intubation and Difficult Intubation, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Awake Endotracheal Intubation, Difficult Intubation, Airway Anesthesia
- What is being tested?
- Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Scheduled Surgery Patients who require an awake intubation
Who may be able to join
- Patients between the ages of 18-80 requiring an awake intubation for endotracheal intubation.
- Ability to speak and understand English
Who cannot join
- Allergy to lidocaine
- Emergent operative case
- Therapeutic anticoagulation
- Mouth opening less than 2 cm
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: 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
- Being tested
- Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic LandmarkProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Assessment of Superior Laryngeal Nerve Block Technique | Not described Receives: Procedure: Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediate Perioperative period
Secondary outcomes (1)
Time to placement of block
Measured: Immediate Perioperative Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Unable to continue recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Miller, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848548
- Sponsor's protocol ID
- SLN Airway Trial
- Status last verified
- Nov 2017
- First submitted
- 19 Feb 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Laryngeal Nerve Block For Airway Anesthesia Efficacy Study
- ClinicalTrials.gov ID
- NCT01848548
- Acronym / sponsor ID
- SLN Airway Trial
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to continue recruit subjects
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of Superior Laryngeal Nerve Block Technique | – | Procedure: Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Scheduled Surgery Patients who require an awake intubation
Key inclusion criteria (2 listed)
- Patients between the ages of 18-80 requiring an awake intubation for endotracheal intubation.
- Ability to speak and understand English
Key exclusion criteria (4 listed)
- Allergy to lidocaine
- Emergent operative case
- Therapeutic anticoagulation
- Mouth opening less than 2 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic LandmarkThe 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. | Procedure or surgery | Assessment of Superior Laryngeal Nerve Block Technique |
Primary outcome
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
1 secondary outcome
Time to placement of block
Time frame: Immediate Perioperative Period
Results and safety
The study was stopped early (reason given: Unable to continue recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Miller, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Awake Endotracheal Intubation and Difficult Intubation, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to continue recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.