Interference with daily activities and major adverse events during esophageal pH monitoring with bravo wireless capsule versus conventional intranasal catheter: a systematic review of randomized controlled trials

Abstract

For three decades, ambulatory 24-hour intranasal pH monitoring has been the established gold standard for detecting acid reflux in patients with refractory gastroesophageal reflux disease. However, device-associated adverse events and unpleasant experiences, reported by patients during pH monitoring have led to the invention of more convenient pH monitors such as Bravo wireless capsule. To compare the interference with daily activities and major adverse events during pH monitoring with Bravo wireless capsule (Bravo) versus conventional intranasal catheter (catheter), PubMed, Cochrane Library, Clinical Trials.gov, and Google Scholar were searched up to March 20, 2015. Only randomized controlled trials in adult patients that compared the interference with routine daily activities and adverse events between Bravo and catheter pH monitors were included. After screening 574 articles, three unique studies with 167 patients met our inclusion criteria. The average age of patients enrolled in these studies was 51 years. Interference with normal daily activities was more in the catheter than Bravo group: 75 ± 5 versus 92 ± 2, P < 0.001 (Andrews et al, findings were reported as100 mm, mean visual analogue scale (VAS) ± standard error of the mean, 100 = completely normal); Wong et al. (mean ± standard error of the mean): 1.3 ± 0.2 versus 0.32 ± 0.1, P = 0.001 and Wenner et al. using 10 cm median VAS (Interquartile range),10 been the worst is 5.7 (2.3-8.0) compared to 0.7 (0.2-3.4), P < 0.0001, respectively. Overall adverse events were more in the catheter group than Bravo (39 ± 4 vs. 26 ± 4, P = 0.012 for Andrews et al. (100 been the worst) and 5.1 (2.0-6.6) vs. 2.1 (0.5-4.6), P < 0.001 for Wenner et al.). No overall adverse events recorded for Wong et al. Most patients in catheter group complained of nasal and throat symptoms. Significantly, runny nose in 24 out of 25 patients (96%) catheter versus 13 out of 25 (52%) Bravo, P = 0.001 and nose pain 15 out 25 (60%) versus 8 out of 25 patients (32%), P = 0.047, respectively for Wong et al. Andrews and Wenner et al also showed profound nasal discomforts in catheter group compared to Bravo (39 ± 3 vs. 10 ± 3, P < 0.001 and 6.5 (1.5-8.0) versus 0.2 (0.0-1.9), P < 0.0001, respectively. Throat symptoms reported in Wong et al. were mainly throat discomfort in catheter group 23 out of 25 patients (92%) versus Bravo 12 out of 25 (48%), P = 0.001 and throat pain catheter (12 out of 25 patients (48%) vs. Bravo 4 out of 25 (16%)), P = 0.032. This trend was also observed in Andrews et al. with profound throat discomfort in the catheter group 43 ± 4 compared to Bravo 19 ± 4, P < 0.001. Majority of the patients randomized to Bravo group reportedly perceived chest pain higher than those in catheter group; 9 out of 25 patients (36%) versus 2 out of 25 (8%), P = 0.037 in Wong et al. 29 ± 4 versus 14 ± 3, P = 0.001 for Andrews et al., 2.4 (0.3-5.9) versus 1.1 (0.3-2.9), P = 0.084 in Wenner et al. respectively (though not statistically significant). Bravo wireless capsule pH monitor interfered l...

ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease

“…With transnasally positioned pH and pH/impedance catheters, the monitoring period generally is limited to 24 hours, while wireless pH telemetry capsule monitoring can last from 48 to 96 hours. In addition, the capsule avoids the physical discomfort and embarrassment of a transnasal catheter, and so, patients are more likely to carry on normal daily activities during capsule pH monitoring (21,22). There is no capsule system available for impedance monitoring, which requires a transnasal catheter.…”

Bio-Inspired Untethered Robot-Sensor Platform for Minimally Invasive Biomedical Sensing

“…This method offers greater comfort and fewer restrictions on daily activities compared to traditional catheter-based methods. ,− The wireless sensing capsule is typically introduced into the gastrointestinal tract either via catheter-based delivery or swallowing accompanied by natural peristaltic waves. ,,, Nevertheless, catheter-based delivery can elicit unfavorable side effects, including throat pain, cough, and esophageal discomfort. Capsule delivery relying on natural movements can lead to incomplete or inaccurate results due to the capsule’s limited mobility, which may impede delivery to the designated area. , Moreover, the constrained mobility and rigid body of the capsule increase the chance of being entrapped within the gastrointestinal tract, leading to blockage. Sometimes surgical interventions are necessitated to remove the entrapped capsule. , Hence, a controllable noninvasive way to deliver sensors for GERD diagnosis is needed.…”

“…Sometimes surgical interventions are necessitated to remove the entrapped capsule. 56,57 Hence, a controllable noninvasive way to deliver sensors for GERD diagnosis is needed. Here, a swallowable soft device consisting of a soft kirigami robot and a passive sensor is developed (Figure 1).…”

“…6,52−55 The wireless sensing capsule is typically introduced into the gastrointestinal tract either via catheter-based delivery or swallowing accompanied by natural peristaltic waves. 6,54,56,57 Nevertheless, catheter-based delivery can elicit unfavorable side effects, including throat pain, cough, and esophageal discomfort. Capsule delivery relying on natural movements can lead to incomplete or inaccurate results due to the capsule's limited mobility, which may impede delivery to the designated area.…”

“…Capsule delivery relying on natural movements can lead to incomplete or inaccurate results due to the capsule's limited mobility, which may impede delivery to the designated area. 54,57 Moreover, the constrained mobility and rigid body of the capsule increase the chance of being entrapped within the gastrointestinal tract, leading to blockage. Sometimes surgical interventions are necessitated to remove the entrapped capsule.…”