Clinical trial NCT03349112: Study: Manometry With & Without Lidocaine
Official title: The Effect of Lidocaine on Perceived Comfort and Swallowing Pressures During High Resolution Pharyngeal Manometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal
Keywords: Manometry
Lidocaine
Pharyngeal
High Resolution Pharyngeal Manometry (HRPM)
Pressure
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: A quantifiable difference of perceived comfort reduction during HRPM with or without lidocaine as assessed through analysis of a visual analog scale.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jodi Hernandez, MS
role: PRINCIPAL_INVESTIGATOR
References: