Laryngeal Disease, Post-operative Pain, Tongue Injury
Conditions
Brief summary
This research is to understand more about the forces that are involved on the tongue and other oropharyngeal structures during laryngeal surgery. This information will be used to determine if these forces can affect outcomes (pain, numbness, taste, etc) and whether factors such as procedure type, surgeon experience (i.e. resident, fellow, attending), and choice of surgical equipment affect these forces. This information may be used to reduce these forces and prevent these issues from happening during certain laryngeal surgeries. For the first 50 patients, force measurements will be taken and correlated to outcome measures . Surgeons will be blinded to the force measurements intra-operatively. For the next 50 patients, surgeons will be given force measurements in real-time intra-operatively allowing adjustments to be made. The impact of this adjustment on outcomes will be determined.
Interventions
PROCEDUREDirect laryngoscopy force modulation
Modification of applied force during direct laryngoscopy using real-time force sensor measurements.
PROCEDUREDirect laryngoscopy without force modulation
Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force
Sponsors
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years old with * undergoing laryngeal surgery with direct laryngoscopy
Exclusion criteria
* Prior history of tongue dysfunction such as glossectomy (hemi or total) or hypoglossal nerve injury * Patient inability to follow up after initial procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form McGill Pain Questionnaire (SF-MPQ) | 1 day, 14 days, and 1 month post-operatively | The SF-MPQ includes the following components: 15 descriptors: * 11 sensory, each rated 0=none, 1=mild, 2=moderate, 3=severe * 4 affective , each rated 0=none, 1=mild, 2=moderate, 3=severe. A Present Pain Intensity (PPI) scale (0=No Pain, 1=Mild, 2=Discomforting, 3=Distressing, 4=Horrible, 5=Excruciating) Visual Analogue Scale of average pain (VAS, 0-10 cm) - higher score is worse pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tongue mobility | 1 month post-operatively | Assessment of changes in tongue mobility post-operatively. My physician report Tongue deviation is: 0 - absent 1 - present |
| Tongue sensation | 1 day, 14 days, and 1 month post-operatively | Assessment of changes in tongue sensation post-operatively, according to patient report: My tongue numbness is: 0 - absent 1. \- minimal 2. \- mild 3. \- moderatre 4. \- severe |
| Change in taste | 1 day, 14 days, 1 month post-operatively | Assessment of changes in taste post-operatively, according to patient report: My tongue numbness is: 0 - absent 1 - minimal 2 - mild 3 - moderatre 4 - severe |
Countries
United States
Contacts
CONTACTRiley Jackson
PRINCIPAL_INVESTIGATORTyler Crosby, MD
University of California, San Francisco
Outcome results
None listed