GERD, Larynx Disease
Conditions
Keywords
Healthy volunteers
Brief summary
The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the short and the long catheters in patients.
Detailed description
Gastroesophageal reflux disease (GERD) has been linked to many disorders and can be diagnosed through a variety of modalities utilizing 24 hour ambulatory pH monitoring which can register the duration, pattern and symptom correlation of distal esophageal acid exposure. This can be accomplished via a catheter probe connected from outside the body and placed through a nostril, advanced past the hypopharynx and down into the distal esophagus. Or, a small pH detector temporarily implanted in the distal esophagus during endoscopy can record reflux events. However, despite available technologies, there has long been a deficiency in detecting extra-esophageal reflux in the upper esophagus/ hypopharynx. This is of interest for gastroenterologists, otolaryngologists, and pulmonologists in the evaluation of extra-esophageal reflux as a potential culprit for asthma, chronic cough, laryngitis, globus, and non-cardiac chest pain. Until now, there has not been a device sensitive enough for accurately detecting extra-esophageal reflux (EERD) and clinicians have relied upon subjective response to empiric treatment with acid reducing medications to determine whether acid reflux was at the root of the symptoms. There are currently no well designed published studies with this device to assess its role in this group of difficult to treat patients.
Interventions
DEVICEDx-pH Probe
24 hour ph monitoring
PROCEDUREManometry
procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female volunteers aged 18 to 65 years old. 2. Control group: No known history of GERD or EERD or prior PPI use. 3. GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy. 4. EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.
Exclusion criteria
1. Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population. 2. Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study. 3. Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia) 4. Expected non-compliance. 5. Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours). 6. Recent nasal surgery or nasal obstruction. 7. Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form) 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in pH From Baseline to <4 | 24 hours | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. |
| Decrease in pH From Baseline to <5 | 24 hours | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals. |
| Decrease in pH From Baseline to <6 | 24 hours | The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Reflux Events | 24 hours | Reflux event was calculated for a drop in pH from baseline to \<6 and each event had to last more than 5 seconds and could not be during the meals. |
Countries
United States
Participant flow
Recruitment details
Volunteers for all three groups were recruited from the Vanderbilt Medical Center
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers With no History of GERD or EERD or PPI Use Healthy volunteers with no history of GERD or EERD or PPI use
Dx-pH Probe: 24 hour ph monitoring
Manometry: procedure to measure LES and UES | 20 |
| Volunteers With Gastroesophageal Reflux Disaese (GERD) History of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy | 17 |
| Volunteers With Laryngopharangeal Reflux (LPR) Suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing,and hoarseness. | 10 |
| Total | 47 |
Baseline characteristics
| Characteristic | Healthy Volunteers With no History of GERD or EERD or PPI Use | Volunteers With Gastroesophageal Reflux Disaese (GERD) | Volunteers With Laryngopharangeal Reflux (LPR) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 17 Participants | 9 Participants | 46 Participants |
| Region of Enrollment United States | 20 participants | 17 participants | 10 participants | 47 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 6 Participants | 29 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 4 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 0 / 17 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 17 | 0 / 10 |
Outcome results
Primary
Decrease in pH From Baseline to <4
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.
Time frame: 24 hours
Population: Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Volunteers With no History of GERD or EERD or PPI Use | Decrease in pH From Baseline to <4 | 1.1 distal esophagus total % time pH <4 |
| Volunteers With History of Gastroesophageal Reflux Disease | Decrease in pH From Baseline to <4 | 3.2 distal esophagus total % time pH <4 |
| Volunteers With Laryngopharangeal Reflux (LPR) | Decrease in pH From Baseline to <4 | 3.8 distal esophagus total % time pH <4 |
p-value: 0.05Wilcoxon (Mann-Whitney)
Primary
Decrease in pH From Baseline to <5
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.
Time frame: 24 hours
Population: Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Volunteers With no History of GERD or EERD or PPI Use | Decrease in pH From Baseline to <5 | 3.0 distal esophagus total % time pH <5 |
| Volunteers With History of Gastroesophageal Reflux Disease | Decrease in pH From Baseline to <5 | 6.5 distal esophagus total % time pH <5 |
| Volunteers With Laryngopharangeal Reflux (LPR) | Decrease in pH From Baseline to <5 | 13 distal esophagus total % time pH <5 |
Primary
Decrease in pH From Baseline to <6
The three study groups underwent dual pH measurements of the oropharyngeal as well as esophageal acid exposure employing the regular length probe for the oropharynx and the custom-designed long probe for the distal esophagus. The reason for the custom-designed esophageal measurement was to ensure that events noted in the oropharynx originated distally and were of gastric source. Measurements for the two locations were time synchronized to ensure accuracy. Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.
Time frame: 24 hours
Population: Calculations were based on length of time spent in upright and supine positions, and a combination of the two positions. Reflux event was calculated for a drop in pH from baseline to either \<4, or \<5, or \<6 and each event had to last more than 5 seconds and could not be during the meals.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Volunteers With no History of GERD or EERD or PPI Use | Decrease in pH From Baseline to <6 | 11 distal esophagus total % time pH <6 |
| Volunteers With History of Gastroesophageal Reflux Disease | Decrease in pH From Baseline to <6 | 29 distal esophagus total % time pH <6 |
| Volunteers With Laryngopharangeal Reflux (LPR) | Decrease in pH From Baseline to <6 | 31 distal esophagus total % time pH <6 |
Secondary
Number of Reflux Events
Reflux event was calculated for a drop in pH from baseline to \<6 and each event had to last more than 5 seconds and could not be during the meals.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Healthy Volunteers With no History of GERD or EERD or PPI Use | Number of Reflux Events | 6.5 reflux events |
| Volunteers With History of Gastroesophageal Reflux Disease | Number of Reflux Events | 102 reflux events |
| Volunteers With Laryngopharangeal Reflux (LPR) | Number of Reflux Events | 75 reflux events |