Study: Manometry With & Without Lidocaine

Study Overview
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Brief Summary
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The purpose of this study is to determine whether subjects report a difference in comfort with High Resolution Pharyngeal Manometry (HRPM) conducted following application of lidocaine as an anesthetic as compared to HRPM conducted without anesthetic.

Detailed Description
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High resolution pharyngeal manometry (HRPM) is used for assessing swallowing pressure along the length of the pharynx and upper esophageal sphincter. Pressure measurements in the region of the velopharynx, tongue base, and upper esophageal sphincter are obtained by passing a catheter with pressure sensors through the patient's nose and past the upper esophageal sphincter. Patients are presented various volumes of liquid to swallow and potentially asked to perform postural strategies such as a head turn or chin tuck during swallowing while the catheter is in place. Clinically, approximately 90% of patients report various discomfort associated with the procedure. Discomfort can result in patient refusal to participate or an inaccurate picture of a patient's swallowing pressures. Conversely, use of anesthesia can potentially alter swallowing physiology. Recent studies have studied the effects of lidocaine on penetration/aspiration and subject discomfort during flexible endoscopic evaluations, yet findings are inconclusive or contradictive. Investigators aim to determine whether subjects report a difference in comfort with HRPM conducted following application of lidocaine as an anesthetic as compared to HRPM conducted without anesthetic.

Official Title
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The Effect of Lidocaine on Perceived Comfort and Swallowing Pressures During High Resolution Pharyngeal Manometry

Conditions
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Normal

Intervention / Treatment
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* Behavioral: 4% Lidocaine Spray
* Behavioral: 2% Viscous Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female adults 18-65. All races. Able to consent for self. Exclusion Criteria: History of dysphagia. History of previous pharyngeal or esophageal manometry. History of facial fracture or abnormalities precluding passage of catheter through nares. History of esophageal pathology including previous resection or perforation. Pregnant Known lidocaine allergy or sensitivity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: During both the anesthetized and non-anesthetized conditions as per standard of care, the study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter. During only the anesthetized condition, subjects will receive up to .8 ml of a 4% Lidocaine spray to both nares.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anesthetized<br>A study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter, Participants in this group will additionally receive .8 mL of a 4% Lidocaine spray to both nares prior to HRPM. | Behavioral: 4% Lidocaine Spray<br>* 2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally.<br>Behavioral: 2% Viscous Lidocaine<br>* 2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.<br>|
| Placebo Comparator: Non-Anesthetized<br>A study team member will apply 1 mL of 2% viscous lidocaine to each nares prior to the passage of the catheter. Randomized participants in this group will not receive .8 mL of a 4% Lidocaine spray prior to HRPM . | Behavioral: 2% Viscous Lidocaine<br>* 2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A quantifiable difference of perceived comfort reduction during HRPM with or without lidocaine as assessed through analysis of a visual analog scale. | Following HRPM without additional lidocaine and following HRPM with additional lidocaine, the subject will be asked to rate their level of comfort during the procedure using a visual analog scale. | Assessing the change of the visual analog scale between two procedural study visits. Data will be reported at study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manometry, Lidocaine, Pharyngeal, High Resolution Pharyngeal Manometry (HRPM), Pressure