NormalNCT03349112
Study: Manometry With & Without Lidocaine
A study testing 4% Lidocaine Spray and 2% Viscous Lidocaine in people with Normal, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal
- What is being tested?
- 4% Lidocaine Spray and 2% Viscous Lidocaine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2015to 9 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female adults 18-65.
- All races.
- Able to consent for self.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53792
About this study
Official title: The Effect of Lidocaine on Perceived Comfort and Swallowing Pressures During High Resolution Pharyngeal Manometry
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.
Read the 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.
- Conditions
- Normal
- Being tested
- 4% Lidocaine Spray, 2% Viscous Lidocaine
- Keywords
- Manometry, Lidocaine, Pharyngeal, High Resolution Pharyngeal Manometry (HRPM), Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% Lidocaine SprayBehavioural
2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally.
2% Viscous LidocaineBehavioural
2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.
| Study group | Role | What they receive |
|---|---|---|
| Anesthetized | Active comparator | 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. Receives: Behavioral: 4% Lidocaine Spray; Behavioral: 2% Viscous Lidocaine |
| Non-Anesthetized | Placebo comparator | 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 . Receives: Behavioral: 2% Viscous Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start22 Dec 2015
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormalStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jodi Hernandez, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349112
- Sponsor's protocol ID
- 2015-0485
- Other IDs
- A539772, SMPH/SURGERY/SURGERY*SP
- Status last verified
- Oct 2019
- First submitted
- 31 Aug 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lidocaine on Perceived Comfort and Swallowing Pressures During High Resolution Pharyngeal Manometry
- ClinicalTrials.gov ID
- NCT03349112
- Acronym / sponsor ID
- 2015-0485
- Conditions
- Normal
- Keywords
- Manometry, Lidocaine, Pharyngeal, High Resolution Pharyngeal Manometry (HRPM), Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anesthetized | Active comparator | Behavioral: 4% Lidocaine Spray, Behavioral: 2% Viscous LidocaineA 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. |
| Non-Anesthetized | Placebo comparator | Behavioral: 2% Viscous LidocaineA 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 . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female adults 18-65.
- All races.
- Able to consent for self.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4% Lidocaine Spray2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally. | Behavioural | Anesthetized |
| 2% Viscous Lidocaine2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group. | Behavioural | Anesthetized, Non-Anesthetized |
Primary outcome
A quantifiable difference of perceived comfort reduction during HRPM with or without lidocaine as assessed through analysis of a visual analog scale.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Normal
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodi Hernandez, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4% Lidocaine Spray and 2% Viscous Lidocaine in people with Normal, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A quantifiable difference of perceived comfort reduction during HRPM with or without lidocaine as assessed through analysis of a visual analog scale. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.