Health TrialsbyHealthPanel

Force Sensor Study

ConditionsLaryngeal DiseasePost-operative PainTongue Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>18 years old with

undergoing laryngeal surgery with direct laryngoscopy

Disqualifiers

Prior history of tongue dysfunction such as glossectomy (hemi or total) or hypoglossal nerve injury

Patient inability to follow up after initial procedure

Trial design

Design model

Factorial

Treatments tested in this trial

  • Direct laryngoscopy force modulation

    Procedure/Surgery

    Modification of applied force during direct laryngoscopy using real-time force sensor measurements.

  • Direct laryngoscopy without force modulation

    Procedure/Surgery

    Patients will undergo direct laryngoscopy as is done in standard of care without active modulation of applied force

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Surgeon blindedActive comparator 1 intervention
Group B: Surgeon unblindedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Short Form McGill Pain Questionnaire (SF-MPQ)

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

Time frame
1 day, 14 days, and 1 month post-operatively

Secondary outcomes

1

Tongue mobility

Assessment of changes in tongue mobility post-operatively. My physician report Tongue deviation is: 0 - absent 1 - present

Time frame
1 month post-operatively
2

Tongue sensation

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

Time frame
1 day, 14 days, and 1 month post-operatively
3

Change in taste

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

Time frame
1 day, 14 days, 1 month post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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