Nervous System Diseases

Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Behaviors and Mental Disorders

Rare Diseases

Paralysis

Vocal Cord Paralysis

Dysphonia

Hoarseness

Laryngeal Diseases

Globus Sensation

Neurologic Manifestations

Voice Disorders

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Vagus Nerve Diseases

Cranial Nerve Diseases

Conversion Disorder

Hysteria

Dissociative Disorders

Somatoform Disorders

Mental Disorders

Psychotic Disorders

Spasmodic Dysphonia

Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study.

The Cheung-Bearelly Aesthesiometer will be used to deliver a range of calibrated stimuli through the channeled flexible laryngoscope to assess sensation of the laryngopharynx.

Cheung-Bearelly Aesthesiometer

A procedure to examine your larynx (voice box)

Transnasal Laryngoscopy

Patient-reported health and behavioral outcomes measures will be administered

Questionnaires

James Lappin, Jr.

Yue Ma, MD

A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.

PRIMARY OBJECTIVES:

I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).

II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).

SECONDARY OBJECTIVES:

I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.

II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.

III. To assess patient reported outcomes (PROs).

EXPLORATORY OBJECTIVES:

I. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:

* modified barium swallow (MBS) study kinematics;
* MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
* MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
* Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
* Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES).

OUTLINE:

Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).

Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders

Elicitation of LAR is defined as a unilateral or bilateral laryngeal adduction immediately following laryngeal stimulus through frame-by-frame analysis of video recordings (visualized on laryngoscopy). An acceptable tactile stimulus is near orthogonal (less than 30 degrees deviation) to the mucosal surface and unobstructed by salivary forces. The percentage of participants with LAR will be reported

The PAS is a widely-used ordinal scale metric used to describe severity of aspiration. The PAS score is multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material). The PAS is an 8-point ordinal scale, with a total score ranging from 1 representing the least and 8 representing the highest or most severe score.

The PRLS is defined as a binary response to participants' self-reported detection of laryngeal stimulation. Once the participant indicates they perceived the stimulus, the research team will ask the participant to provide a perceptual strength rating on a 1-10 scale, with higher scores indicated a greater strength of stimulus.

Percentage of participants with visualized laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus will be recorded by the clinician and reported.

National Spasmodic Dysphonia Association

University of California, San Francisco

Neoplasms

Gland and Hormone Related Diseases

Recurrence

Thyroid Neoplasms

Thyroid Diseases

Goiter

All Drugs and Chemicals

Rocuronium

Group I.IONM in thyroid surgery.Once the vagus has been detected,nerve conduction data will be detected with IONM. If the muscle relaxant effect is not detected, it will be detected with TOF device.

Group B.the vagal nerve is detected and then 2 mg / kg of sugammadex sodium is administered to remove the muscle relaxant effect

Group B. Sugammadex sodium-IONM

Turgut Donmez, surgeon

Mehmet Emin Gunes, surgeon

Turgut Donmez, MD

Thyroidectomy is a frequently performed surgeon by the head and neck and endocrine surgeons. In recent years, surgical techniques and technological developments have resulted in a significant reduction in complication rates. Despite these advances, there is still a great deal of anxiety about the sound problems that can be experienced in patients after surgery. In the past years,the investigators have tried to prevent recurrent nerve paralysis by using intraoperative nerve monitoring (IONM). The use of IONM has begun to be preferred by many surgeons in the investigator's country. However, the use of IONM decreases the number of recurrent nerve paralysis are still being discussed and many studies have been done. In this study, it is aimed to prevent the formation of recurrent nerve paralysis in order to safely carry out the IONM by removing the effects of neuromuscular blockade drugs using sugammadex sodium medicine in the thyroidectomy operations.

Patients who will undergo thyroidectomy using the IONM in the General Surgery Clinic of Istanbul, Bakırköy Dr.Sadi Konuk Training and Research Hospital. In this prospective observational clinical trial, the patients will be divided into two groups and the study will be performed as randomize. Randomization Patients who arrive consecutively, will be included in the study group (Group I IONM, group B IONM-sugammadex sodium). In both groups, anesthesia induction should be done with 3 mg / kg propofol, 2 ugr / kg fentanyl, 0.6 mg / kg rocuronium bromide, as the intubation tube, the number appropriate for the patient, After reaching the throat loom, the patient is entrapped and then the operation is started. After reaching the thyroid loin and hanging the throid with the swab sutures, the lobe is taken out with the finger maneuver and then the vascular nerve packet is dissected and the vagal nerve is exposed. IONM(Medtronic-NIM) were detected in the recurrent nerve thyroglossal groove and 100 microvolts or more were measured with nerve monitoring. + Acceptance of resection was started and IONM After the intubation of the group B-sugammadex sodium was started, the left hand ulnar sinus TOF-Guard device was placed and operation started. After reaching the thyroid loops and hanging the throids with hanging sutures and removing the lobe with finger maneuver, the vascular nerve was disassembled and the vagal nerve was dislocated. Then the electrical value was recorded with IONM and sugammadex sodium 2 mg / kg was made. and the TOF response at 4th minute is over 90% of the value to be measured and if the IONM is 100 microvolts higher, the recurrent nerve is found in the troglossal groove and the nerve is followed with the IONM and the resection procedure is started and the tirodidectomy will be performed. V0: vagal nerve initial value; V1: value before troid resection; V2: value after troid resection; R1: value after troid resection, R2: value after troid resection. Preoperative and postoperative vocal cord examination will be examined by otolaryngologist. Size, weight, sex, ASA scores, operation times, complications will be recorded. If there is no signal in RLN with intraoperative IONM and RLN paralysis will be accepted if there is inactivity in the vocal cord at the 1st postoperative ENT specialist vocal cord examinations. RLN paralysis will be accepted if there is inactivity in the cord at the vocal cord examination of the postoperative specialist ENT specialist. The ENT specialist and general surgeon will follow up and if the vocal cord is still in motion, the permanent RLN will be considered a paralysis.

Group A. Sugammadex sodium-IONM in thyroid surgery Group B.Standart technique-IONM in thyroid surgery

Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery

Reversal of Rocuronium-Induced Neuromuscular Blockade by Sugammadex Increase for Efficiency of Intraoperative Neural Monitoring in the Thyroid Surgery

Patients who are accepted to participate in the study will be gathered in the pool. The patients' data will be entered on the computer. The computer and patients will be randomized and set up on the day of surgery. The preop, perop and postop data of the patients will be recorded on the computer.

postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined.

V1: value to receive enough nerve conduction for IONM use from the vagus nerve

V2:Vagus value after resection of thyroid lobe

initial value after vagus sinus is detected

the time that the muscle relaxant is shown by the peripheral nerve stimulator whose effect has disappeared.TOF\>0.9

Lütfiye Nuri Burat Government Hospital

Principal investigator

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Muscle Weakness

Paresis

Thyroid Nodule

Hypoparathyroidism

Thyroid Cancer, Papillary

Hypocalcemia

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Parathyroid Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Adenocarcinoma

Adenocarcinoma, Papillary

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Control (status/post-s/p total thyroidectomy-TT, without complication- demographics and BMI matched)

Experimental (s/p TT, with only vocal cord paralysis-VCP, uni or bilateral)

Experimental (s/p TT, with only hypocalcemia-H, transient or permanent)

Experimental (s/p TT, with both vocal cord paralysis-VCP and hypocalcemia-H);

Subgroups:

4.1. VCP (Permanent) + H (Permanent) 4.2. VCP (Transient) + H (Transient) 4.3. VCP (Permanent) + H (Transient) 4.4. VCP (Transient) + H (Permanent)

Please answer:

* Improvement in hypocalcemia also make a positive effect on voice? (any objective sign? Ca? PTH?)
* Return of voice is parallel with the improvement in hypocalcemia? (any objective sign? Ca? PTH?

Patients with thyroid diseases either benign (e.g. multinodular goitre) or malign (e.g. thyroid carcinoma) will be prepared for total thyroidectomy procedure and will be enrolled.

Total thyroidectomy

Ethem UNAL, MD, PhD, USMLE & IFSO-Certified, Board CSS

Kadir YILDIRAK, MD

Ethem UNAL, MD, PhD, USMLE & IFSO- Certified Board CSS

Kadir M YILDIRAK, MD

Sema YUKSEKDAG, MD

In the present study, the severity of recurrent laryngeal nerve injury (RLNI) and hypocalcemia (H) will be followed-up and the probable interrelation between them will be proposed considering the clinical situation of patients, e.g. improvement in hypocalcemia also make a positive effect on voice? (any objective sign? Ca? PTH?), return of voice is parallel with the improvement in hypocalcemia? Postoperative calcium (Ca), parathyroid hormone (PTH), regular vocal cord evaluations by ear-nose-throat (ENT) exams, deterioration-stability-improvement of clinical symptoms regarding both Ca metabolism and vocal cord function will be noted at regular intervals (postoperative day 1-3-first, weekly control/first month, monthly/first 6-month, 3-monthly/6-12 months) at outpatient controls. Serum Ca, PTH, ENT evaluation of vocal cords-noted.

Total thyroidectomy is currently the preferred surgical treatment modality for both thyroid carcinomas and benign disorders such as multinodular goitre, since it minimizes the risk of recurrence and eliminates the complication risks of repeat or completion surgery. Vocal cord paralysis due to injury to recurrent laryngeal nerve (RLN) is the most dreaded complication of total thyroidectomy. The reported incidence of temporary RLN injury (RLNI) varies between 0 and 12 %, while the incidence of permanent RLNI has been reported to be much lower (0-3.5 %). In case of bilateral RLNI, respiratory distress and aspiration can develop rapidly and may result in mortality. Therefore, all precautions including close monitoring and tracheostomy should be undertaken without any delay. The best known technique to avoid injury to RLN is meticulous dissection of the nerve throughout its anatomic pathway. However, functional impairment of RLN is not visible macroscopically and intraoperative nerve monitoring (IONM) has been developed to monitor the nerve to avoid unnecessary dissection. Meticulous hemostasis can be achieved with harmonic sealing instrument, since improper hemostasis is known to increase the risk of RLNI. Despite the lack of evidence to support an advantage of IONM over the standard anatomic dissection of RLN, surgeons have adopted it in increasing ratios. The second most feared compliation of thyroidectomy is iatrogenic hypocalcemia. Transient symptomatic hypocalcemia after total thyroidectomy occurs in approximately 7% to 25% of cases, but permanent hypocalcemia is less common (0.4% to 13.8%). Size and invasion of tumor, operative trauma and vascular compromise determines the severity of symptoms.

Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort

Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: Prospective, Matched-randomized Observational Cohort Compatible With STROBE Guidelines

Study is open to high-volume INTERNATIONAL endocrine surgery centers, eager to join to present STROBE compatible observational study

Available upon email requests@drethemunal@gmail.com

Any improvement recorded? VCP? H? vice versa

Umraniye Education and Research Hospital

MD, PhD, USMLE & IFSO-Certified, BCSS, Associated Professor of General Surgery and Surgical Oncology

Pain

Polyps

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Respiratory Tract Neoplasms

Acute Graft Versus Host Disease

This arm will be the current standard of care

This arm will use the vibroacoustic device to provide a mechanical stimulus to the patient as treatment to reduce pain and anxiety. Augmented reality glasses will be worn but will be turned off.

This arm will use the augmented reality game to provide a visual stimulus to the patient as treatment to reduce pain and anxiety. Vibroacoustic device will be worn but will be turned off.

This arm will use both the augmented reality game and vibroacoustic device to provide a visual stimulus to the patient as treatment to reduce pain and anxiety.

Mechanical stimulus is provided to the patient through a vibroacoustic device via vibration around the neck.

Vibroacoustic stimulation on

Visual stimulus is provided through augmented reality glasses in the form of a game.

Augmented Reality on

Vibroacoustic device is worn but turned off.

Vibroacoustic stimulation off

Augmented reality glasses are worn but turned off.

Augmented reality off

James J Daniero, MD

Elena Miller, MPH

James Daniero, MD

Claudia N Gutierrez, MD

Adithya Reddy, BSE

In-office procedures (IOPs) are a cost-effective, and safe alternative to many operating room procedure, with benefits such as reduced anesthesia risk. One of the major causes of failed in-office procedures or requirement of conversion to the operating room is poor patient tolerance. Vibration and augmented reality (AR) can be used as non-pharmacologic treatment options to treat patient anxiety and pain by using the physiology proposed by the gate-way theory of pain as well as distraction. This study seeks to compare anxiety and pain perception with patient reported survey data, as well as physiologic indicators of stress such as heart rate variability (HRV) within patients undergoing IOPs in a laryngology office with and without vibration and AR treatment.

In-office procedures (IOPs) represent a cost-effective and safe alternative to operating room procedures for a myriad of disease processes across medical and surgical specialties. IOPs are performed under local anesthetic without general anesthesia or sedation, resulting in faster and often safer procedures by eliminating risks associated with general anesthesia. IOPs are primarily limited by patient tolerance, as there is a lack of currently available non-pharmacologic treatment options for patient anxiety, stress, discomfort, and pain during these procedures.

The Gate Control Theory of Pain postulates that only a limited amount of simultaneous sensory stimuli can be processed by the central nervous system and therefore non-painful stimuli, such as vibration or virtual distraction (i.e. virtual or augmented reality), can eliminate or lessen the perception of concurrent painful stimuli. The use of these non-painful stimuli has been shown to have clinical utility in the setting of procedures such as percutaneous injections and wound dressing changes.

However, the coupling of multiple sensory distraction techniques has not been described for IOPs. Furthermore, no investigation of sensory distraction techniques to reduce patient discomfort within the field of otolaryngology has been conducted. The focus of the proposed project is to improve patient experience during IOPs by coupling a novel vibroacoustic stimulation device with original AR software applications.

In-office otolaryngology procedures specifically involve using a rigid endoscope or a flexible nasolarynogoscopy to visualize the inside of a patient nose, sinus, posterior oropharynx, and vocal cords. Using these imaging modalities, awake, in-office procedures can be performed. However, these procedures are often very uncomfortable and anxiety producing.

The goal of the study is to determine whether or not wearing an augmented reality headset with a novel game and vibroacoustic simulation device can help reduce anxiety and improve the patient experience of in-office otolaryngology procedures. The device consists of an augmented reality headset worn by the patient, a vibration device that is applied to the patient's neck to help reduce the sensation of the procedure, and a clicker that allows the patient to interact with the augmented reality game environment.

Patients who are undergoing in-office laryngology procedures (procedures on their vocal cords) will be randomized into a control group augmented reality (AR) group, vibration group, and combined AR and vibration group. The control group will wear a sham augmented reality head set during the procedure. The AR group will have a game played on the head set to distract them during the procedure. The patient will interact with the game use a hand held clicker.

Each participant will answer a survey before and after the procedure assessing their anxiety. Each participant will also wear a one-lead EKG to measure their heart rate through the procedure. The subjective and physiological level will be compared between the two groups

Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures

Using Augmented Reality With Vibroacoustic Stimulation to Improve the Patient Experience During In-Office Otorhinolaryngology Procedures

There is no intention to share individual participant data with other researchers.

Visual analog scale rating of max perceived pain during procedure

Visual analog scale rating of average perceived pain during procedure

Visual analog scale rating of how nervous about pain patient was during procedure

Visual analog scale rating of percent of time spent thinking about pain during procedure

Difference between heart rate variability during procedure compared with pre-procedure

Difference between maximum heart rate during procedure compared with pre-procedure

Difference between average heart rate during procedure compared with pre-procedure

Measure change in Stait-Trait anxiety inventory State 5 question score pre and post-procedure.

Likert scale rating of satisfaction of treatment group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort	NCT06078527	Presbylarynx Aspiration Spasmodic Dysph... Globus Pharynge... Larynx Paralysi... Laryngeal Disea... Vocal Cord Para... Iatrogenic Inju... Sensory Neuropa...	Cheung-Bearelly... Transnasal Lary... Questionnaires	18 Years - 85 Years	University of California, San Francisco
Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery	NCT03634956	Vocal Cord Para... Recurrent Laryn...	Group B. Sugamm...	18 Years - 75 Years	Lütfiye Nuri Burat Government Hospital
Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort	NCT04396912	Iatrogenic Hypo... Iatrogenic Hypo... Vocal Cord Para... Vocal Cord Pare... Vocal Cord; Inj... Thyroid Cancer,... Thyroid Cancer Multinodular Go... Thyroid Neoplas... Thyroid Nodule Calcium Deficie... PTH	Total thyroidec...	17 Years -	Umraniye Education and Research Hospital
Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures	NCT06227039	Pain, Acute Vocal Fold Poly... Vocal Cord Para... Laryngeal Neopl...	Vibroacoustic s... Augmented Reali... Vibroacoustic s... Augmented reali...	18 Years -	University of Virginia
Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures	NCT06227039	Pain, Acute Vocal Fold Poly... Vocal Cord Para... Laryngeal Neopl...	Vibroacoustic s... Augmented Reali... Vibroacoustic s... Augmented reali...	18 Years -	University of Virginia

Spots Global Cancer Trial Database for vocal cord paralysis