Force Sensor Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Direct laryngoscopy force modulation, Direct laryngoscopy without force modulation.
- Who it may be relevant to
- Registry conditions: Laryngeal Disease, Post-operative Pain, Tongue Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Biomechanical Analysis of Force Loadings During Suspension Microlaryngoscopy
Overview
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
- Procedure Direct laryngoscopy force modulation
Modification of applied force during direct laryngoscopy using real-time force sensor measurements. - Procedure Direct laryngoscopy without force modulation
Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force
Primary outcome measures
- Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 1 day, 14 days, and 1 month post-operatively]
Secondary outcome measures (3)
- Tongue mobility [Time frame: 1 month post-operatively]
- Tongue sensation [Time frame: 1 day, 14 days, and 1 month post-operatively]
- Change in taste [Time frame: 1 day, 14 days, 1 month post-operatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of California San Francisco — San Francisco
Identifiers
NCT: NCT07434583 · 24-42623