Normal
Conditions
Keywords
Manometry, Lidocaine, Pharyngeal, High Resolution Pharyngeal Manometry (HRPM), Pressure
Brief summary
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
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.
Interventions
BEHAVIORAL4% Lidocaine Spray
2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally.
BEHAVIORAL2% Viscous Lidocaine
2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female adults 18-65. 2. All races. 3. Able to consent for self.
Exclusion criteria
1. History of dysphagia. 2. History of previous pharyngeal or esophageal manometry. 3. History of facial fracture or abnormalities precluding passage of catheter through nares. 4. History of esophageal pathology including previous resection or perforation. 5. Pregnant 6. Known lidocaine allergy or sensitivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A quantifiable difference of perceived comfort reduction during HRPM with or without lidocaine as assessed through analysis of 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. | 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. |
Countries
United States
Outcome results
None listed