Dialysis costs for a health system participating in value-based care.

OBJECTIVES: Unplanned "crash" dialysis starts are associated with worse outcomes and higher costs, a challenging problem for health systems participating in value-based care (VBC). We examined expenditures and utilization associated with these events in a large health system. STUDY DESIGN: Retrospective, single-center study at Cleveland Clinic, a large, integrated health system participating in VBC contracts, including a Medicare accountable care organization. METHODS: We analyzed beneficiaries who transitioned to dialysis between 2017 and 2020. Crash starts involved initiating inpatient hemodialysis (HD) with a central venous catheter (CVC). Optimal starts were initiated with either home dialysis or outpatient HD without a CVC. Suboptimal starts were initiated with outpatient HD with a CVC or inpatient HD without a CVC. RESULTS: A total of 495 patients initiated chronic dialysis: 260 crash starts, 130 optimal starts, and 105 suboptimal starts. Median predialysis 12-month cost was $67,059 for crash starts, $17,891 for optimal starts, and $7633 for suboptimal starts (P < .001). Median postdialysis 12-month cost was $71,992 for crash starts, $55,427 for optimal starts, and $72,032 for suboptimal starts (P = .001). Predialysis inpatient admission per 1000 beneficiaries was 1236 per 1000 for crash starts vs 273 per 1000 for optimal starts and 170 per 1000 for suboptimal starts (P < .001). Postdialysis inpatient admission for crash starts was 853 per 1000 vs 291 per 1000 for optimal starts and 184 per 1000 for suboptimal starts (P < .001). CONCLUSIONS: In a major health system, crash starts demonstrated the highest cost and hospital utilization, a pattern that persisted after dialysis initiation. Developing strategies to promote optimal starts will improve VBC contract performance.

Frequency of Use and Outcomes of Colonoscopy in Individuals Older Than 75 Years.

Importance: The benefits from colorectal cancer (CRC) screening may take 10 to 15 years to accrue. Therefore, screening is recommended for older adults who are in good health. Objective: To determine the number of screening colonoscopies done in patients older than 75 years with a life expectancy of fewer than 10 years, diagnostic yield, and associated adverse events within 10 days and 30 days of the procedure. Design: This cross-sectional study with a nested cohort between January 2009 and January 2022 in an integrated health system assessed asymptomatic patients older than 75 years who underwent screening colonoscopy in the outpatient setting. Reports with incomplete data, any indication other than screening, patients who had a colonoscopy within the previous 5 years, and patients with a personal history of inflammatory bowel disease or CRC were excluded. Exposures: Life expectancy based on a prediction model from previous literature. Main Outcomes and Measures: The primary outcome was the percentage of screened patients who had limited (<10 years) life expectancy. Other outcomes included colonoscopy findings and adverse events that developed within 10 days and 30 days of the procedure. Results: A total of 7067 patients older than 75 years were included. The median (IQR) age was 78 (77-79) years, 3967 (56%) were women, and 5431 (77%) were White with an average of 2 comorbidities (taken from a select group of comorbidities). The proportion of colonoscopies performed on patients with a life expectancy of fewer than 10 years aged 76 to 80 years was 30% in both sexes and increased with age-82% of men and 61% of women aged 81 to 85 years (71% total), and 100% of patients beyond the age of 85 years. Adverse events requiring hospitalizations were common at 10 days (13.58 per 1000) and increased with age, particularly among patients older than 85 years. The detection of advanced neoplasia varied from 5.4% among patients aged 76 to 80 years to 6.2% in those aged 81 to 85 years and 9.5% among patients older than 85 years (P = .02). Of the total population, 15 patients (0.2%) had invasive adenocarcinoma; among patients with a life expectancy of fewer than 10 years, 1 of 9 was treated, whereas 4 of 6 patients with a life expectancy of greater than or equal to 10 years were treated. Conclusions and Relevance: In this cross-sectional study with a nested cohort, most screening colonoscopies performed in patients older than 75 years were in patients with limited life expectancy and associated with increased risk of complications. Colorectal cancer was exceedingly rare.

The Natural History of Asymptomatic Gallstones: A Longitudinal Study and Prediction Model.

BACKGROUND & AIMS: Despite the high prevalence of asymptomatic gallstones (AGs), there are limited data on their natural history. We aimed to determine the rate of symptom development in a contemporary population, determine factors associated with progression to symptomatic gallstones (SGs), and develop a clinical prediction model. METHODS: We used a retrospective cohort design. The time to first SG was shown using Kaplan-Meier curves. Multivariable competing risk (death) regression analysis was used to identify variables associated with SGs. A prediction model for the development of SGs after 10 years was generated and calibration curves were plotted. Participants were patients with AGs based on ultrasound or computed tomography from the general medical population. RESULTS: From 1996 to 2016, 22,257 patients (51% female) with AGs were identified; 14.5% developed SG with a median follow-up period of 4.6 years. The cumulative incidence was 10.1% (±0.22%) at 5 years, 21.5% (±0.39%) at 10 years, and 32.6% (±0.83%) at 15 years. In a multivariable model, the strongest predictors of developing SGs were female gender (hazard ratio [HR], 1.50; 95% CI, 1.39-1.61), younger age (HR per 5 years, 1.15; 95% CI, 1.14-1.16), multiple stones (HR, 2.42; 95% CI, 2.25-2.61), gallbladder polyps (HR, 2.55; 95% CI, 2.14-3.05), large stones (HR, 2.03; 95% CI, 1.80-2.29), and chronic hemolytic anemia (HR, 1.90; 95% CI, 1.33-2.72). The model showed good discrimination (C-statistic, 0.70) and calibration. CONCLUSIONS: In general medical patients with AGs, symptoms developed at approximately 2% per year. A predictive model with good calibration could be used to inform patients of their risk of SGs.

Application of optical character recognition with natural language processing for large-scale quality metric data extraction in colonoscopy reports.

BACKGROUND AND AIMS: Colonoscopy is commonly performed for colorectal cancer screening in the United States. Reports are often generated in a non-standardized format and are not always integrated into electronic health records. Thus, this information is not readily available for streamlining quality management, participating in endoscopy registries, or reporting of patient- and center-specific risk factors predictive of outcomes. We aim to demonstrate the use of a new hybrid approach using natural language processing of charts that have been elucidated with optical character recognition processing (OCR/NLP hybrid) to obtain relevant clinical information from scanned colonoscopy and pathology reports, a technology co-developed by Cleveland Clinic and eHealth Technologies (West Henrietta, NY, USA). METHODS: This was a retrospective study conducted at Cleveland Clinic, Cleveland, Ohio, and the University of Minnesota, Minneapolis, Minnesota. A randomly sampled list of outpatient screening colonoscopy procedures and pathology reports was selected. Desired variables were then collected. Two researchers first manually reviewed the reports for the desired variables. Then, the OCR/NLP algorithm was used to obtain the same variables from 3 electronic health records in use at our institution: Epic (Verona, Wisc, USA), ProVation (Minneapolis, Minn, USA) used for endoscopy reporting, and Sunquest PowerPath (Tucson, Ariz, USA) used for pathology reporting. RESULTS: Compared with manual data extraction, the accuracy of the hybrid OCR/NLP approach to detect polyps was 95.8%, adenomas 98.5%, sessile serrated polyps 99.3%, advanced adenomas 98%, inadequate bowel preparation 98.4%, and failed cecal intubation 99%. Comparison of the dataset collected via NLP alone with that collected using the hybrid OCR/NLP approach showed that the accuracy for almost all variables was >99%. CONCLUSIONS: Our study is the first to validate the use of a unique hybrid OCR/NLP technology to extract desired variables from scanned procedure and pathology reports contained in image format with an accuracy >95%.

Comparative Effectiveness of Commercial Bowel Preparations in Ambulatory Patients Presenting for Screening or Surveillance Colonoscopy.

BACKGROUND: Inadequate bowel preparation (IBP) is associated with reduced adenoma detection. However, limited research has examined the impact of different commercial bowel preparations (CBPs) on IBP and adenoma detection. We aim to determine whether type of CBP used is associated with IBP or adenoma detection. METHODS: We retrospectively evaluated outpatient, screening or surveillance colonoscopies performed in the Cleveland Clinic health system between January 2011 and June 2017. IBP was defined by the Aronchick scale. Multilevel mixed-effects logistic regression was performed to assess the association between CBP type and IBP and adenoma detection. Fixed effects were defined as demographics, comorbidities, medication use, and colonoscopy factors. Random effect of individual endoscopist was considered. RESULTS: Of 153,639 colonoscopies, 75,874 records met inclusion criteria. Median age was 54; 50% were female; 17.7% had IBP, and adenoma detection rate was 32.6%. In adjusted analyses, compared to GoLYTELY, only NuLYTELY [OR 0.66 (95% CI 0.60, 0.72)] and SuPREP [OR 0.53 (95% CI 0.40, 0.69)] were associated with reduced IBP. Adenoma detection did not vary based on the type of bowel preparation used. CONCLUSIONS: Among patients referred for screening or surveillance colonoscopy, choice of CBP was not associated with adenoma detection. Decisions about CBP should be based on other factors, such as tolerability, cost, or safety.

Shifting Cost-drivers of Health Care Expenditures in Inflammatory Bowel Disease.

BACKGROUND: Inflammatory bowel diseases (IBD) are costly, chronic illnesses. Key cost-drivers of IBD health care expenditures include pharmaceuticals and unplanned care, but evolving treatment approaches have shifted these factors. We aimed to assess changes in cost of care, determine shifts in IBD cost-drivers, and examine differences by socioeconomic and insurance status over time. METHODS: The Medical Expenditure Panel Survey (MEPS), a nationally representative database that collects data on health care utilization and expenditures from a nationally representative sample since 1998, was utilized. Adult subjects with IBD were identified by ICD-9 codes. To determine changes in per-patient costs or cost-drivers unique to IBD, a control population of rheumatoid arthritis (RA) subjects was generated and matched in 1:1 case to control. Total annual health care expenditures were obtained and categorized as outpatient, inpatient, emergency, or pharmacy related. Temporal cohorts from 1998 to 2015 were created to assess change over time. Per-patient expenditures were compared by disease state and temporal cohort using weighted generalized linear models. RESULTS: A total of 641 IBD subjects were identified and matched to 641 RA individuals. From 1998 to 2015, median total annual health care expenditures nearly doubled (adjusted estimate 2.20; 95% CI, 1.6-3.0) and were 36% higher in IBD compared with RA. In IBD, pharmacy expenses increased 7% to become the largest cost-driver (44% total expenditures). Concurrently, inpatient spending in IBD decreased by 40%. There were no significant differences in the rate of change of cost-drivers in IBD compared with RA. CONCLUSIONS: Per-patient health care costs for chronic inflammatory conditions have nearly doubled over the last 20 years. Increases in pharmaceutical spending in IBD may be accompanied by reduction in inpatient care. Additional studies are needed to explore patient-, disease-, system-, and industry-level cost mitigation strategies.

Combined Immunodeficiency With Inflammatory Bowel Disease in a Patient With TTC7A Deficiency.

Tetratricopeptide repeat domain-7A (TTC7A) deficiency causing combined immunodeficiency with inflammatory bowel disease (IBD) is rare. This case report alerts physicians to the possibility of TTC7A deficiency causing combined immunodeficiency with IBD and also highlights some of the current treatment options. We describe a 19-year-old patient with a compound heterozygote TTC7A mutation causing combined immunodeficiency, IBD, and multiple intestinal atresia. Compound heterozygote TTC7A mutations are known to cause combined immunodeficiency and IBD. Although rare, clinicians should be alerted to this variant and should understand the general approach to treatment.

Association of Adenoma and Proximal Sessile Serrated Polyp Detection Rates With Endoscopist Characteristics.

Importance: Research demonstrates adenoma detection rate (ADR) and proximal sessile serrated polyp detection rate (pSSPDR) are associated with endoscopist characteristics including sex, specialty, and years in practice. However, many studies have not adjusted for other risk factors associated with colonic neoplasia. Objective: To assess the association between endoscopist characteristics and polyp detection after adjusting the factors included in previous studies as well as other factors. Design, Setting, and Participants: This cohort study was conducted in the Cleveland Clinic health system with data from individuals undergoing screening colonoscopies between January 2015 and June 2017. The study analyzed data using methods from previous studies that have demonstrated significant associations between endoscopist characteristics and ADR or pSSPDR. Multilevel mixed-effects logistic regression was performed to examine 7 endoscopist characteristics associated with ADRs and pSSPDRs after controlling for patient demographic, clinical, and colonoscopy-associated factors. Exposures: Seven characteristics of endoscopists performing colonoscopy. Main Outcomes and Measures: The ADR and pSSPDR, with a hypothesis created after data collection began. Results: A total of 16 089 colonoscopies were performed in 16 089 patients by 56 clinicians. Of these, 8339 patients were male (51.8%), and the median (range) age of the cohort was 59 (52-66) years. Analyzing the data by the methods used in 4 previous studies yielded an association between endoscopist and polyp detection; surgeons (OR, 0.49 [95% CI, 0.28-0.83]) and nongastroenterologists (OR, 0.50 [95% CI 0.29-0.85]) had reduced odds of pSSPDR, which was similar to results in previous studies. In a multilevel mixed-effects logistic regression analysis, ADR was not significantly associated with any endoscopist characteristic, and pSSPDR was only associated with years in practice (odds ratio, 0.86 [95% CI, 0.83-0.89] per increment of 10 years; P < .001) and number of annual colonoscopies performed (odds ratio, 1.05 [95% CI, 1.01-1.09] per 50 colonoscopies/year; P = .02). Conclusions and Relevance: The differences in ADRs that were associated with 7 of 7 endoscopist characteristics and differences in pSSPDRs that were associated with 5 of 7 endoscopist characteristics in previous studies may have been associated with residual confounding, because they were not replicated in this analysis. Therefore, these characteristics should not influence the choice of endoscopist for colorectal cancer screening. However, clinicians further from their training and those with lower colonoscopy volumes have lower adjusted pSSPDRs and may need additional training to help increase pSSPDRs.

Modifiable Factors Associated with Quality of Bowel Preparation Among Hospitalized Patients Undergoing Colonoscopy.

INTRODUCTION: Inadequate bowel preparation (IBP) is a common problem in hospitalized patients; however, little is known about how to prevent IBP. In a large, multihospital system, we evaluated the association between modifiable factors and IBP rate. METHODS: We reviewed data from adult (≥18 years) inpatients undergoing colonoscopy between January 2011 and June 2017. Colonoscopies performed in the intensive care unit or lacking descriptions of bowel preparation quality were excluded. Multivariate logistic regression analysis was performed to identify factors associated with IBP. A counterfactual analysis was performed to assess the potential contribution of modifiable factors to IBP. RESULTS: Of 8,819 patients that were included (median age of 64 years; 50.5% female), 51% had IBP. Patients with IBP stayed in the hospital one day longer than those with adequate bowel preparation (P < .001). Modifiable factors associated with IBP include opiate use within three days of colonoscopy (OR, 1.31; 95% CI, 1.18, 1.45), colonoscopy performed after 12:00 pm (OR, 1.25; 95% CI, 1.1, 1.41), and solid diet the day before colonoscopy (OR, 1.37; 95% CI, 1.18, 1.59). In the counterfactual analysis, if all patients avoided these three conditions, adjusted IBP rates were reduced by 5.6%. CONCLUSIONS: Among hospitalized patients undergoing colonoscopy, IBP rates are high and associated with an increased length of stay. Avoiding opiates before colonoscopy, performing colonoscopy before noon, and maintaining patients on a liquid diet or nil per os might significantly reduce IBP rates.

Resuming Anticoagulation following Upper Gastrointestinal Bleeding among Patients with Nonvalvular Atrial Fibrillation-A Microsimulation Analysis.

BACKGROUND: Among patients with nonvalvular atrial fibrillation (NVAF) who have sustained an upper gastrointestinal bleed (UGIB), the benefits and harms of oral anticoagulation change over time. Early resumption of anticoagulation increases recurrent bleeding, while delayed resumption exposes patients to a higher risk of ischemic stroke. We therefore set out to estimate the expected benefit of resuming anticoagulation as a function of time after UGIB among patients with NVAF. METHODS: We created a decision-analytic model estimating discounted quality-adjusted life-years when patients with NVAF resume anticoagulation on each day following UGIB. We simulated from a health system perspective over a lifelong time horizon. RESULTS: Peak utility for warfarin was achieved by resumption 41 days after hemostasis from the index UGIB. Resumption between days 32 and 51 produced greater than 99.9% of the peak utility. Peak utility for apixaban was achieved by resumption 32 days after the index UGIB. Resumption between days 21 and 47 produced greater than 99.9% of the peak utility. Of input parameters, results were most sensitive to underlying stroke risk. Specifically, across the range of CHA2DS2-Vasc scores, the optimal day of resumption varied by around 11 days for patients resuming warfarin and by around 15 days for patients resuming apixaban. Results were less sensitive to underlying risk of rebleeding. CONCLUSIONS: For patients with NVAF following UGIB, warfarin is optimally restarted approximately six weeks following hemostasis, and apixaban is optimally restarted approximately one month following hemostasis. Modest changes to this timing based on probability of thromboembolic stroke are reasonable.

Patient-Initiated Colonoscopy Scheduling Effectively Increases Colorectal Cancer Screening Adherence.

BACKGROUND AND AIM: We identified patients without medical record evidence of up-to-date colorectal cancer (CRC) screening and sent an invitation letter to self-schedule a colonoscopy without requiring prior primary care or gastroenterologist consultation. The aim of the study was to evaluate the response rate to the letter and factors associated with colonoscopy completion. METHODS: A computer algorithm invited patients not up to date with CRC screening, with an INR < 1.5, and living within 300 miles of the Cleveland Clinic main campus through a letter. Patients scheduled a colonoscopy through a dedicated phone line without any prior physician consultation. Clinical, demographic, and socioeconomic variables were extracted from the EMR through natural language algorithms. We analyzed the percentage of patients who completed a colonoscopy within 6 months of sending the letter and factors associated with colonoscopy completion. RESULTS: A total of 145,717 letters were sent. 1451 patients were deceased and excluded from analysis. 3.8% (5442) of letter recipients completed a colonoscopy. The strongest factors associated with colonoscopy completion on multivariate analysis included family history of polyps (OR 3.1, 95% CI 2.3, 4.2) or CRC (OR 2.1, 95% CI 1.7, 2.5). Other factors included younger age, male gender, married status, closer distance to endoscopy center, number of visits in the year prior, statin use, and diabetes. There were no immediate procedural complications. CONCLUSIONS: Patient-initiated colonoscopy in response to letter invitation for CRC screening is effective and safe with safeguards established a priori. Consultation with a gastroenterologist or primary care physician is not necessary prior to colonoscopy. To our knowledge, this is the first study to evaluate patient-initiated colonoscopy for CRC cancer screening.

Common bile duct dilation after bariatric surgery.

BACKGROUND: Biliary dilation suggests obstruction and prompts further work up. Our experience with endoscopic ultrasound and endoscopic retrograde cholangiopancreatography in the symptomatic post-bariatric surgery population revealed many patients with radiographically dilated bile ducts, but endoscopically normal studies. It is unclear if this finding is phenomenological or an effect of surgery. Additionally, it is unknown whether the type of bariatric surgery alters biliary pathophysiology. Thus, we studied whether a change occurs in biliary diameter following Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG). METHODS: A single-center retrospective study assessing biliary diameter before and after RYGB or SG based on radiographic imaging. All adult patients undergoing RYGB or SG from January 2010 to December 2013 who had imaging studies before and > 3 months after surgery were included. Those with known obstructive etiologies and those without post-operative imaging were excluded. Common bile duct (CBD) diameter was re-read by a radiologist at the same location in the CBD for pre- and post-operative imaging. Baseline clinical factors and cholecystectomy status were collected. RESULTS: 269 patients met inclusion criteria (193 RYGB;76 SG). Between the groups, there were no significant differences in pre-operative characteristics. Average time from surgery to repeat imaging was 24.1 months. After adjusting for pre-operative factors, subjects who underwent an RYGB had an increase in CBD diameter of 1.4 mm (95% CI 0.096, 0.18), which was greater than the change following SG 0.5 mm(95% CI - 0.007, 0.11). The magnitude of this change did not depend on prior cholecystectomy in the RYGB cohort. Within the SG group, for patients without a prior cholecystectomy, there was a significant increase in post-operative CBD diameter of 0.8 mm(95% CI 0.02, 0.14). CONCLUSION: Bariatric surgery results in CBD dilation, with changes more pronounced after RYGB. Biliary dilation occurs irrespective of cholecystectomy status. Further work is necessary to determine the cause and clinical implications of this phenomenon.

Value-Based Health Care in Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) is a chronic inflammatory disease associated with significant resource utilization and health care burden. It is emerging as a global disease affecting an increasing proportion of the population. Along with evolving epidemiological trends, the paradigm of managing IBD has also changed. With a burgeoning repertoire of therapeutic options, improved use of health informatics, and emphasis on health care value, the treatment paradigm for IBD has experienced seismic shifts. In this review, we focused on value-based health care (VBHC)-a health care model that emphasizes monitoring outcomes to emphasize patient-centered, cost-effective IBD patient care. Several quality initiatives have been developed worldwide, and successful models of care were created for proper implementation of these initiatives. Although there are significant challenges to scale these models to a national level, it is still possible to successfully implement VBHC models within health systems to improve the quality of care provided to patients with IBD.

Screening colonoscopy: High quality regardless of endoscopist specialty.

BACKGROUND: Data suggests that screening colonoscopy performed by non-gastroenterologists are lower quality with lower adenoma detection rates (ADR). The aim of this study was to investigate the effect of the endoscopist's specialty on quality parameters in screening colonoscopy. METHODS: Screening colonoscopies performed between January 2016 and June 2017 were queried from a prospectively maintained institutional database. Quality parameters including overall ADR, gender-specific ADR, total examination time, cecal intubation rate and withdrawal time were compared between gastroenterology (GI) and colorectal surgery (CRS). RESULTS: A total of 15,276 patients were included in the study (mean age 60.3 ±â€¯8; 52.4% female). 11,339 (74.2%) of the colonoscopies were performed by GI, and 3937 (25.7%) were by CRS. Withdrawal time and total scope time were shorter in the GI group. Cecal intubation rate was comparable. Overall ADR, female ADR and male ADR were significantly higher in the GI group, although both groups met national quality benchmarks. CONCLUSION: Both specialties achieve appropriate quality metrics for screening colonoscopy. Prospectively evaluating each endoscopist's outcomes, regardless of specialty, is an important tool for ongoing quality improvement towards better patient outcomes.

Gallstones: Watch and wait, or intervene?

Gallstones are common in the United States, affecting an estimated 1 in 7 adults. Fortunately, they are asymptomatic in up to 80% of cases, and current guidelines do not recommend cholecystectomy unless they cause symptoms. Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones, acute cholecystitis, and gallstone pancreatitis.

Online Educational Video Improves Bowel Preparation and Reduces the Need for Repeat Colonoscopy Within Three Years.

PURPOSE: Unsatisfactory bowel preparation has been reported in up to 33% of screening colonoscopies. Patients' lack of understanding about how a good bowel preparation can be achieved is one of the major causes. Patient education has been explored as a possible intervention to improve this important endpoint and has yielded mixed results. We compared the proportion of satisfactory bowel preparations and adenoma detection rates between patients who viewed and did not view an educational video on colonoscopy. METHODS: An educational video on colonoscopy, accessible via the Internet, was issued to all patients with planned procedures between 2010 and 2014. Viewing status of the video was verified through a unique code linked to each patient's medical record. Excellent, good, or adequate bowel preparations were defined as "satisfactory," whereas fair, poor, or inadequate bowel preparations were defined as "unsatisfactory." RESULTS: A total of 2530 patients undergoing their first outpatient screening colonoscopy were included; 1251 patients viewed the educational video and 1279 patients did not see the video. Multivariate analysis revealed higher rates of satisfactory bowel preparation in the educational video group (92.3% [95% confidence interval [CI], 84.8-96.3] vs 87.4% [95% CI, 76.4-93.7], P <.001). Need for a repeat colonoscopy within 3 years was also higher in patients who did not see the video (6.6% [95% CI, 2.8-14.7] vs 3.3% [95% CI 1.3-7.8], P <.001). CONCLUSION: Patient-centered educational video improves bowel preparation quality and may reduce the need for an earlier repeat procedure in patients undergoing screening colonoscopy.

Capnographic Monitoring in Routine EGD and Colonoscopy With Moderate Sedation: A Prospective, Randomized, Controlled Trial.

OBJECTIVES: Regulatory changes requiring the use of capnographic monitoring for endoscopic procedures using moderate sedation have placed financial challenges on ambulatory and hospital endoscopy centers across the United States due to the increased cost of training endoscopy personnel and purchasing both capnography-monitoring devices and specialized sampling ports. To date, there has been no published data supporting the use of capnographic monitoring in adult patients undergoing routine endoscopic procedures with moderate sedation. The aim of this randomized, parallel group assignment trial was to determine whether intervention based on capnographic monitoring improves detection of hypoxemia in patients undergoing routine esophagogastroduodenoscopy (EGD) or colonoscopy with moderate sedation. METHODS: Healthy patients (ASA Physical Classification (ASAPS) I and II)) scheduled for routine outpatient EGD or colonoscopy under moderate sedation utilizing opioid and benzodiazepine combinations were randomly assigned to a blinded capnography alarm or open capnography alarm group. In both study arms, standard cardiopulmonary monitoring devices were utilized with additional capnographic monitoring. The primary end point was the incidence of hypoxemia defined as a fall in oxygen saturation (SaO2) to <90% for ≥10 s. Secondary outcomes included severe hypoxemia, apnea, disordered respirations, hypotension, bradycardia, and early procedure termination for any cause. RESULTS: A total of 452 patients were randomized; 218 in the EGD and 234 in the colonoscopy groups; 75 subjects in the EGD group (35.9%) and 114 patients (49.4%) in the colonoscopy group were male, and average body mass index was 27.9 and 29.1 (kg/m(2)), respectively. The blinded and open alarm groups in each study arm were similar in regards to use of opioids and/or benzodiazepines and ASAPS classification. There was no significant difference in rates of hypoxemia between the blinded and open capnography arms for EGD (54.1% vs. 49.5; P=0.5) or colonoscopy (53.8 vs. 52.1%; P=0.79). CONCLUSIONS: Capnographic monitoring in routine EGD or colonoscopy for ASAPS I and II patients does not reduce the incidence of hypoxemia (ClinicalTrials.gov number, NCT01994785).