Mechanisms Preventing Pharyngeal Reflux
ConditionGERD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMedical College of Wisconsin
About this trial
The overall goal is to define and characterize the manometric characteristics of UES incompetence associated with objectively documented pharyngeal reflux. The investigators will use endoscopic reflux detection as gold standard.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 85
GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included and recruited from our GI & Otolaryngology clinics
GERD patients without complaint of supra-esophageal symptoms and regurgitation will be included and recruited from our GI & Otolaryngology clinics
Asthma patients with and without supra-esophageal symptoms will be included and recruited from clinics affiliated with Medical College of Wisconsin. Asthma patients with the following classifications of asthma severity will be included: intermittent, mild persistent, moderate persistent, and severe persistent (as long as no acute asthma exacerbation at the time of the study)
Disqualifiers
Age <18 or >85
Active alcohol or drug abuse
History of ear, nose, throat and pulmonary diseases suspected of being GERD induced
History of head and neck malignancy and chemo-radiation therapy to the head and neck
Trial design
Design model
Parallel
Treatments tested in this trial
Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy
Diagnostic testCombined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally. Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.
Slow and rapid intra-esophageal infusion
Diagnostic testA 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.
Treatment groups
300 Participants
are divided into 5 treatment groupsGroup A: GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)Active comparator 2 interventions
Group B: Age and gender matched healthy controlsActive comparator 2 interventions
Group C: Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint)Active comparator 2 interventions
Group D: Asthma patients with and without supra-esophageal symptomsActive comparator 2 interventions
Group E: Age and gender matched patient controls for diagnosed Barrett's esophagus patientsActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Pressure Data Analysis
All pressure measurements will be recorded at a 35HZ frequency and measured in reference to the atmospheric pressure UES and LES pressures will be measured utilizing the e-sleeve function of the manometric analysis software. All UES, LES and esophageal baseline pressures will be measured as peaks and troughs over 3 tidal volume respiratory cycles at stable resting conditions when no pharyngeal, gastric, esophageal, UES or LES events are present. Type, frequency, amplitude, onset, and duration of the UES response along with the LES and esophageal body response will be recorded.
Time frame
During simulated reflux perfusion of the esophagus2
Videoendoscopic data analysis
Onset of the entry of colored refluxate into the pharynx though the UES inlet will be determined and correlated with the UES, esophageal and LES pressure phenomena, impedance and pH events. Endoscopic documentation of pharyngeal reflux will be considered the gold standard and impedance and pH data will be compared to it.
Time frame
During simulated reflux perfusion of the esophagusSponsors and contacts
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Source ClinicalTrials.gov