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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03349112
Other study ID # 2015-0485
Secondary ID A539772SMPH/SURG
Status Completed
Phase N/A
First received
Last updated
Start date December 22, 2015
Est. completion date November 9, 2018

Study information

Verified date October 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 9, 2018
Est. primary completion date November 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
4% Lidocaine Spray
2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally.
2% Viscous Lidocaine
2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.

Locations

Country Name City State
United States University of Wisconsin - Madison Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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