RESUMEN
A rise in duodenoscope-associated infections, especially in regard to multidrug-resistant organisms, has led to an increase in scrutiny regarding duodenoscope reprocessing. Endoscopic retrograde cholangiopancreatography scopes have a specialized elevator wire channel, allowing more flexible duct cannulation; however, this channel can be difficult to reprocess with standard techniques. Although strict adherence to manufacturer reprocessing protocols remains the primary means of infection prevention, periodic microbiological surveillance is a Food and Drug Administration-recommended practice that the Medical University of South Carolina has implemented to further prevent duodenoscope-associated infections. The Medical University of South Carolina obtains 2 separate cultures from 2 duodenoscopes every 2 months, which undergo standard speciation and sensitivity and are returned to use once negative at 48 hours. The initial results of the Medical University of South Carolina's surveillance cultures are negative for any multidrug-resistant organisms; however, other centers should consider implementing surveillance cultures into their reprocessing practices and closely monitoring for future endoscope infection prevention modalities.
Asunto(s)
Duodenoscopios , Contaminación de Equipos , Colangiopancreatografia Retrógrada Endoscópica , Desinfección , Contaminación de Equipos/prevención & control , Humanos , Control de InfeccionesRESUMEN
GOALS: To investigate the frequency of throat clearing (TC) and cough and how often each is associated with a positive symptom index (SI) for reflux. BACKGROUND: Many patients referred to our esophageal laboratory for gastroesophageal reflux disease (GERD) evaluation have "atypical" or "extraesophageal" symptoms. STUDY: We reviewed ambulatory impedance-pH studies of 267 patients referred for evaluation of possible GERD symptoms from January 2012 to December 2013 to evaluate the frequency of cough, TC, and their association with an abnormal number of reflux episodes. Patients with <3 symptom events/24 hours were excluded. Additional analysis was done for those with ≥24 (excessive) symptoms of TC or cough/24 hours. Eighty percent of patients were tested on proton pump inhibitor therapy. SI for either or both symptoms was calculated. RESULTS: A total of 112 of 267 patients (42%) reported both TC and cough on study day, 76/267 (28%) cough without TC and 79/267 (30%) TC without cough. Only 9/112 (8%) had a positive SI, versus 20/76 (26%) and 17/79 (22%) for cough (P=0.0006) and TC (P=0.007), respectively.A total of 136 of 267 patients (51%) reported 3 to 23 TC events/24 hours; 27/136 (20%) had a positive SI. Fifty-five of 267 (27%) had "excessive" TC. Only 7/55 (13%) had a positive SI (P=0.24).A total of 142 of 267 patients (53%) reported 3 to 23 cough events/24 hours; 43/142 (30%) had a positive SI. Forty-six of 267 (17%) had "excessive" cough. Only 6/46 (13%) had a positive SI (P=0.02).Analyses based on ON/OFF therapy, also showed same low rate of positive test and significantly higher number of reflux episodes in those with positive SI. CONCLUSIONS: Although cough and TC are often considered possible GERD symptoms, there is a low probability of objective association. This is even less likely if both symptoms are present. Those patients who reported "excessive" cough are less likely to have a positive SI.
Asunto(s)
Tos/etiología , Monitorización del pH Esofágico/métodos , Reflujo Gastroesofágico/diagnóstico , Inhibidores de la Bomba de Protones/administración & dosificación , Impedancia Eléctrica , Femenino , Reflujo Gastroesofágico/tratamiento farmacológico , Humanos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
STUDY OBJECTIVE: Because it has been hypothesized that histamine2 receptor antagonists (H2 RAs) might interfere with the action of proton pump inhibitors (PPIs) when the drugs are given concomitantly, we sought to compare the pharmacodynamic effects of simultaneous administration of a PPI and an H2 RA with the effects of each drug administered alone. DESIGN: Prospective, randomized, double-blind, three-way crossover study. SETTING: Esophageal motility laboratory at a large teaching hospital. SUBJECTS: Twenty-one healthy volunteers. INTERVENTION: Subjects were randomized to one of three treatment arms: an H2 RA (ranitidine 300 mg) plus placebo, a PPI (omeprazole 40 mg) plus placebo, or ranitidine 300 mg plus omeprazole 40 mg, all given once/day at 8 a.m., 30 minutes before a standard breakfast, for 1 week. The subjects then received the other two treatments, with each treatment period separated by a 1-week washout period. MEASUREMENTS AND MAIN RESULTS: The primary outcome was length of time that the gastric pH remained higher than 4. Secondary outcomes were median gastric pH higher than 4 and percentage of time that the gastric pH remained higher than 4. On day 7, ambulatory intragastric pH was recorded over an 8-hour period in each treatment arm. The combination of ranitidine and omeprazole resulted in a significantly longer time that the gastric pH remained higher than 4 (median 410.5 min [interquartile range (IQR) 298.5-454.25 min]) versus either omeprazole alone (median 356.7 min [IQR 254.9-419.2 min], p=0.023) or ranitidine alone (134.1 min [IQR 99.9-302.5 min], p<0.0001). Median gastric pH was also significantly higher when omeprazole and ranitidine were given in combination (pH 5.92 [IQR 4.75-6.46]) than either omeprazole alone (pH 4.88 [IQR 4.27-6.11], p=0.001) or ranitidine alone (pH 2.31 [IQR 2.04-5.27], p=0.0003). Likewise, the percentage of time that the gastric pH remained higher than 4 was significantly higher when omeprazole and ranitidine were given in combination (median 85.52%) than either omeprazole alone (74.31%, p=0.027) or ranitidine alone (27.94%, p=0.0002). CONCLUSION: When a PPI and H2 RA were administered concomitantly 30 minutes before breakfast, the H2 RA did not decrease the acid suppressive ability of the PPI; rather, it improved gastric acid control. Thus these results failed to support the initial hypothesis of this study. Further prospective studies are needed to test these findings in patients with gastroesophageal reflux disease as well as those with erosive esophagitis.
Asunto(s)
Ácido Gástrico/metabolismo , Reflujo Gastroesofágico/prevención & control , Antagonistas de los Receptores H2 de la Histamina/farmacología , Omeprazol/farmacología , Inhibidores de la Bomba de Protones/farmacología , Ranitidina/farmacología , Adulto , Estudios Cruzados , Método Doble Ciego , Quimioterapia Combinada , Femenino , Antagonistas de los Receptores H2 de la Histamina/administración & dosificación , Humanos , Masculino , Omeprazol/administración & dosificación , Estudios Prospectivos , Inhibidores de la Bomba de Protones/administración & dosificación , Ranitidina/administración & dosificación , Resultado del TratamientoRESUMEN
GOAL: We hypothesized that sleeping left-side down with the head/torso elevated reduces recumbent gastroesophageal reflux (GER). BACKGROUND: Previous studies show that sleeping with head of bed elevated or on wedge reduces GER and lying left-side down reduces GER versus right-side down and supine. No prior studies have evaluated the potential compounding effects of lying in an inclined position combined with lateral positioning on GER. STUDY: We evaluated a sleep-positioning device (SPD) consisting of an inclined base and body pillow that maintains lateral position while elevating the head/torso. This was a single institution, randomized controlled trial involving 20 healthy volunteers receiving 4 six-hour impedance-pH tests. After placement of reflux probe, subjects returned home, ate standardized meal, and lay down in randomly assigned positions: SPD right-side down (SPD-R), SPD left-side down (SPD-L), standard wedge any position (W), or flat any position (F). A wireless accelerometer documented position during each study. Number of reflux episodes (RE) and esophageal acid exposure (EAE) were calculated over 6 hours. RESULTS: Significantly less EAE occurred during sleeping SPD-L versus sleeping W, SPD-R, and F. The most EAE occurred during sleeping SPD-R despite use of the positioning device. RE were significantly less SPD-L than SPD-R. Patients sleeping SPD-L and SPD-R spent the majority of first 2 hours and greater than half of 6 hours in assigned position. Patients sleeping W and F averaged more time supine than right or left. CONCLUSIONS: The sleep positioning device maintains recumbent position effectively. Lying left-side down, it reduces recumbent esophageal acid exposure.
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Reflujo Gastroesofágico/prevención & control , Postura/fisiología , Sueño/fisiología , Posición Supina/fisiología , Adulto , Impedancia Eléctrica , Diseño de Equipo , Monitorización del pH Esofágico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: Insufficient data exist for how long endoscopes can be stored after reprocessing. Concern about possible microbial colonization has led to various recommendations for reprocessing intervals among institutions, with many as short as 5 days. A significant cost savings could be realized if it can be demonstrated that endoscopes may be stored for as long as 21 days without risk of clinically significant contamination. OBJECTIVE: To demonstrate whether flexible endoscopes may be stored for as long as 21 days after reprocessing without colonization by pathogenic microbes. DESIGN: Prospective, observational study. SETTING: Tertiary care center. ENDOSCOPES: Four duodenoscopes, 4 colonoscopes, and 2 gastroscopes. INTERVENTION: Microbial testing of endoscope channels. MAIN OUTCOME MEASUREMENTS: Culture results at days 0, 7, 14, and 21. RESULTS: There were 33 positive cultures from 28 of the 96 sites tested (29.2% overall contamination rate). Twenty-nine of 33 isolates were typical skin or environmental contaminants, thus clinically insignificant. Four potential pathogens were cultured, including Enterococcus, Candida parapsilosis, α-hemolytic Streptococcus, and Aureobasidium pullulans; all were likely clinically insignificant as each was only recovered at 1 time point at 1 site, and all grew in low concentrations. There were no definite pathogenic isolates. LIMITATIONS: Single center. CONCLUSION: Endoscopes can be stored for as long as 21 days after standard reprocessing with a low risk of pathogenic microbial colonization. Extension of reprocessing protocols to 21 days could effect significant cost savings.
Asunto(s)
Recuento de Colonia Microbiana , Endoscopios/microbiología , Contaminación de Equipos/estadística & datos numéricos , Candida/aislamiento & purificación , Ahorro de Costo/métodos , Enterococcus/aislamiento & purificación , Humanos , Estudios Prospectivos , Streptococcus/aislamiento & purificación , Factores de TiempoRESUMEN
Nurses often function as capsule endoscopy "pre-readers" to save physicians' time and potentially increase diagnostic yield. Training pre-readers is time consuming, not standardized, and may not be feasible during regular business hours. A way to evaluate the progress and accuracy of pre-readers is needed to ensure competency. The aim of this study was to introduce a feedback and progress assessment tool for training novice capsule endoscopy pre-readers. We created a 1-page form with listings of potential findings for each segment of the examination. Findings could be circled or written in. The trainee reviewed capsule studies and filled out the form on each of 220 patients. The physician reviewers subsequently critiqued the data forms, providing feedback regarding missed lesions, overcalls, and overall agreement. Our trainee achieved consistent agreement with the physician reviewers, after reading 80 studies. In conclusion, a simple, 1-page standardized data sheet can be used to facilitate training of novice capsule pre-readers without significant time commitment from the supervising physician. Future studies may validate this resource-efficient instrument as a training and assessment tool for nurses, physicians, and other practitioners learning capsule endoscopy.
Asunto(s)
Endoscopía Capsular/educación , Endoscopía Capsular/enfermería , Educación en Enfermería/métodos , Capacitación en Servicio/métodos , Competencia Clínica , Humanos , Variaciones Dependientes del Observador , Estados UnidosRESUMEN
BACKGROUND: Distal oesophageal spasm is a rare and under-investigated motility abnormality. Recent studies indicate effective bolus transit in varying percentages of distal oesophageal spasm patients. AIM: Explore functional aspects including contraction onset velocity and contraction amplitude cut-off values for simultaneous contractions to predict complete bolus transit. METHODS: We re-examined data from 107 impedance-manometry recordings with a diagnosis of distal oesophageal spasm. Receiver operating characteristic analysis was conducted, regarding effects of onset velocity on bolus transit taking into account distal oesophageal amplitude and correcting for intra-individual repeated measures. RESULTS: Mean area under the receiver operating characteristic curve for saline and viscous swallows were 0.84±0.05 and 0.84±0.04, respectively. Velocity criteria of >30 cm/s when distal oesophageal amplitude>100 mmHg and 8 cm/s when distal oesophageal amplitude<100 mmHg for saline and 32cm/s when distal oesophageal amplitude>100 mmHg and >7 cm/s when distal oesophageal amplitude<100 mmHg for viscous had a sensitivity of 75% and specificity of 80% to identify complete bolus transit. Using these criteria, final diagnosis changed in 44.9% of patients. Abnormal bolus transit was observed in 50.9% of newly diagnosed distal oesophageal spasm patients versus 7.5% of patients classified as normal. Distal oesophageal spasm patients with distal oesophageal amplitude>100 mmHg suffered twice as often from chest pain than those with distal oesophageal amplitude<100 mmHg. CONCLUSION: The proposed velocity cut-offs for diagnosing distal oesophageal spasm improve the ability to identify patients with spasm and abnormal bolus transit.
Asunto(s)
Deglución/fisiología , Espasmo Esofágico Difuso/diagnóstico , Espasmo Esofágico Difuso/fisiopatología , Tránsito Gastrointestinal , Adolescente , Adulto , Anciano , Análisis de Varianza , Área Bajo la Curva , Esfínter Esofágico Inferior/fisiopatología , Esófago/fisiopatología , Femenino , Humanos , Masculino , Manometría , Persona de Mediana Edad , Contracción Muscular , Pletismografía de Impedancia , Curva ROC , Estudios Retrospectivos , Adulto JovenRESUMEN
OBJECTIVES: Refractory heartburn despite acid suppression may be explained by ongoing gastroesophageal reflux disease (GERD) or functional heartburn (FH), i.e., symptoms without evidence of GERD. Impedance-pH monitoring (impedance-pH) detects acid and nonacid reflux and is useful for evaluating acid-suppressed, refractory patients. Intercellular space diameter (ISD) of esophageal epithelium measured by transmission electron microscopy (TEM) is a marker of epithelial damage present in both erosive and nonerosive reflux disease. ISD has not been used to study refractory heartburn or FH. Our aim was to compare ISD in healthy controls and refractory heartburn patients with GERD and FH. METHODS: In refractory heartburn patients (heartburn more than twice/week for at least 2 months despite proton pump inhibitor (PPI) b.i.d.), erosive esophagitis and/or abnormal impedance-pH (increased acid exposure or positive symptom index) defined GERD; normal esophagogastroduodenoscopy (EGD)/impedance-pH defined FH. Asymptomatic, healthy controls had normal EGD and pH-metry. Mean ISD in each subject, determined by blinded TEM of esophageal biopsies, was the average of 100 measurements (10 measurements in each of 10 micrographs). RESULTS: In all, 11 healthy controls, 11 FH, and 15 GERD patients were studied. Mean ISD was significantly higher in GERD compared with controls (0.87 vs. 0.32 µm, P=0.003) and FH (0.87 vs. 0.42 µm, P=0.012). Mean ISD was similar in FH and controls (0.42 vs. 0.32 µm, P=0.1). The proportion of patients with abnormal ISD was significantly higher for GERD compared with FH (60 vs. 9%, P=0.014). CONCLUSIONS: ISD is increased in refractory heartburn patients with GERD but not those with FH. Our findings suggest that measurement of ISD by TEM might be a useful tool to distinguish GERD from FH in patients with refractory heartburn.
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Esófago/ultraestructura , Espacio Extracelular , Reflujo Gastroesofágico/patología , Pirosis/patología , Adulto , Diagnóstico Diferencial , Endoscopía Gastrointestinal , Epitelio/ultraestructura , Monitorización del pH Esofágico , Esofagoscopía , Femenino , Reflujo Gastroesofágico/tratamiento farmacológico , Pirosis/tratamiento farmacológico , Humanos , Masculino , Microscopía Electrónica de Transmisión , Persona de Mediana Edad , Monitoreo Ambulatorio , Inhibidores de la Bomba de ProtonesRESUMEN
BACKGROUND: There is limited information on medications with promotility effects on the esophagus. Studies in healthy volunteers have shown the potential role of the direct cholinergic agonist bethanechol and the serotonin receptor agonist buspirone in improving esophageal motility. It has been also shown that an acetylcholinesterase inhibitor, the short-acting drug edrophonium administered intravenously caused a greater increase in the esophageal contraction amplitude and duration than bethanechol. Edrophonium cannot be used as a promotility therapy owing to short duration of action and lack of oral administration. The use of another acetylcholinesterase inhibitor pyridostygmine with longer duration of action has not been studied. The aim of the study was to evaluate the effect of oral pyridostygmine (60 mg), buspirone (20 mg), and bethanechol (25 mg) on esophageal function assessed by combined multichannel intraluminal impedance-esophageal manometry. MATERIALS AND METHODS: Ten healthy volunteers were enrolled in a double blind randomized 3-period crossover study. Multichannel intraluminal impedance-esophageal manometry recorded esophageal pressures and bolus transit data during 6 liquid and 6 viscous swallows at baseline and 20, 40, and 60 minutes after the randomized oral administration of each drug. RESULTS: Blinded analysis found significant increases in mean distal esophageal amplitude for liquid swallows from baseline to 60 minutes postdosing after pyridostygmine (87.6 vs. 118.0 mm Hg, P<0.001), buspirone (85.1 vs. 101.9 mm Hg, P<0.05), and bethanechol (87.6 vs. 118.8 mm Hg, P<0.01). Only pyridostygmine showed a significant decrease in mean distal onset velocity for liquid swallows at 60 minutes postdosing (3.4 vs. 2.3 cm/s, P<0.01) and increase in total bolus transit time at 60 minutes postdosing (7.9 vs. 9.3 s, P<0.05). All 3 agents significantly increased mean lower esophageal sphincter residual pressure for liquid swallows at 20, 40, and 60 minutes postdosing. Increased lower esophageal sphincter resting pressure was not significant. Similar results were found with viscous swallows. CONCLUSIONS: Oral pyridostygmine, buspirone, and bethanechol enhance esophageal motility with pyridostygmine appearing to have the greatest effect. A potential effect on improving esophageal function and symptoms in patients requires further study.
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Betanecol/farmacología , Buspirona/farmacología , Esófago/efectos de los fármacos , Motilidad Gastrointestinal/efectos de los fármacos , Manometría , Neurotransmisores/farmacología , Bromuro de Piridostigmina/farmacología , Administración Oral , Adulto , Betanecol/administración & dosificación , Buspirona/administración & dosificación , Inhibidores de la Colinesterasa/administración & dosificación , Inhibidores de la Colinesterasa/farmacología , Estudios Cruzados , Deglución/efectos de los fármacos , Deglución/fisiología , Método Doble Ciego , Trastornos de la Motilidad Esofágica/tratamiento farmacológico , Esfínter Esofágico Inferior/efectos de los fármacos , Esfínter Esofágico Inferior/fisiología , Esfínter Esofágico Superior/efectos de los fármacos , Esfínter Esofágico Superior/fisiología , Esófago/fisiología , Femenino , Motilidad Gastrointestinal/fisiología , Humanos , Masculino , Persona de Mediana Edad , Neurotransmisores/administración & dosificación , Bromuro de Piridostigmina/administración & dosificación , Agonistas de Receptores de Serotonina/administración & dosificación , Agonistas de Receptores de Serotonina/farmacología , Viscosidad , Adulto JovenRESUMEN
BACKGROUND & AIMS: Despite proton-pump inhibitors (PPIs), patients may have persistent symptoms of gastroesophageal reflux disease (GERD). We aimed to identify symptom types and frequency experienced by patients on PPI therapy, and to identify the type of reflux, if any, associated with these symptoms. METHODS: A retrospective review was performed of 200 patients on PPI with GERD symptoms during ambulatory impedance-pH testing. The symptom index (SI) was determined for each symptom, and an SI of 50% or more was considered positive. Patients were divided into 2 groups: those with exclusively nonacid reflux (NAR) episodes and those with mixed-acid and NAR episodes. Symptom profiles were compared between these 2 groups. RESULTS: A total of 415 symptoms were reported by the 200 patients on twice-daily PPIs. Throat clearing was most common (24%). A total of 110 (27%) were typical symptoms and 305 (73%) were atypical. Typical symptoms were more likely to have a positive SI than atypical symptoms (48% vs 25%, P < .01). Eighty-four patients (42%) had a positive SI, and 116 patients (58%) had a negative SI. One hundred patients (50%) had only NAR; the other 100 had mixed acid and NAR. Heartburn (21% vs 63%, P < .01) and nausea (8% vs 44%, P < .01) were more likely associated with reflux in the mixed-acid and NAR group. CONCLUSIONS: Patients on PPIs still experience GERD symptoms. Impedance-pH monitoring identifies similar symptom associations with all types of reflux and also clarifies symptoms not related to any reflux.
Asunto(s)
Reflujo Gastroesofágico/tratamiento farmacológico , Reflujo Gastroesofágico/fisiopatología , Monitoreo Fisiológico/métodos , Inhibidores de la Bomba de Protones/administración & dosificación , Adulto , Distribución por Edad , Anciano , Anciano de 80 o más Años , Distribución de Chi-Cuadrado , Estudios de Cohortes , Educación Médica Continua , Impedancia Eléctrica , Esofagoscopía , Femenino , Estudios de Seguimiento , Determinación de la Acidez Gástrica , Reflujo Gastroesofágico/epidemiología , Gastroscopía , Humanos , Concentración de Iones de Hidrógeno , Incidencia , Masculino , Persona de Mediana Edad , Monitoreo Ambulatorio/métodos , Probabilidad , Estudios Retrospectivos , Medición de Riesgo , Distribución por Sexo , Perfil de Impacto de EnfermedadRESUMEN
OBJECTIVE: Multichannel intraluminal impedance and manometry (MII-EM) is performed using ten 5-ml swallows each of a liquid and a viscous solution. However, the manometric diagnosis is based solely on results from the 10 liquid swallows. The aim of this study was to compare esophageal function evaluated with 10 liquid versus 10 viscous swallows using combined MII-EM in patients with various symptoms. MATERIAL AND METHODS: Consecutive studies performed in 300 patients (211F, mean age 54.5 years) were analyzed. The manometric diagnoses were separated into normal and abnormal manometry. MII findings included the number of complete and incomplete transits and total bolus transit time. RESULTS: Manometric diagnosis for liquid and viscous solutions was consistent in 231 (77%) and inconsistent in 69 (23%) patients (p<0.0001). Overall, the number of manometric abnormalities detected with the viscous solution (n=91, 30.3%) was significantly higher (p=0.03) than that detected with the liquid solution (n=60, 20%). Impedance diagnosis for the viscous and liquid solutions was consistent in 238 (79.3%) patients and inconsistent in 62 (20.7%) patients (p<0.0001). Among those 62 patients, 36 (58.1%) had complete bolus transit with the liquid solution and incomplete bolus transit with the viscous solution, and 26 (41.9%) had incomplete bolus transit with the liquid solution and complete transit with the viscous solution (p=0.46). Overall, there was no significant difference between the number of bolus transit abnormalities for the liquid (n=75, 25%) and viscous solutions (n=85, 28.3%, p=0.47). CONCLUSIONS: Our results indicate that a viscous solution detects significantly more manometric abnormalities than a liquid solution. Impedance diagnosis has greater similarity for both the liquid and viscous solutions.
Asunto(s)
Deglución , Trastornos de la Motilidad Esofágica/fisiopatología , Esófago/fisiopatología , Impedancia Eléctrica , Femenino , Humanos , Masculino , Manometría , Persona de Mediana Edad , ViscosidadRESUMEN
Ingestion of acidic foods may produce artifactual drops in pH to < 4 that may be difficult to differentiate from a true acid reflux event. We aimed to evaluate intraesophageal pH changes during the ingestion of acidic food and describe the frequency and implications of acidic food ingestion on ambulatory pH monitoring. Ten normal volunteers (six females; mean age, 34) underwent combined impedance-pH testing with a pH electrode placed 5 cm above the lower esophageal sphincter. Each volunteer received 50 ml each of acidic foods in random order. Nadir and mean pH for 30 sec after ingestion of each substance were recorded. Subsequently 100 randomly selected reflux monitor diaries were reviewed, searching for ingestion of acidic foods, and 100 pH tracings were reviewed to evaluate the impact of including/excluding meal periods on percentage time pH < 4 and DeMeester scores. All foods produced abrupt drops to pH < 4, in 80% of cases exceeding 30 sec. During ambulatory pH monitoring 78% of patients recorded ingestion of at least 1 of the 10 tested substances during meals, the majority admitting ingesting carbonated beverages. Not excluding meal periods would have led to the misinterpretation of 6-16% of tracings, depending on the criteria used to identify abnormal acid exposure. We conclude that ingestion of acidic foods is frequent and carries the risk of overdiagnosing GERD. Current findings support the recommendations to carefully instruct patients to record all oral intake and to exclude meal periods from the analysis.