Patient safety during procedural sedation using capnography monitoring: a systematic review and meta-analysis

OBJECTIVE: To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery relative to visual assessment and pulse oximetry alone. DESIGN AND SETTING: Systematic literature review and random effects meta-analysis of randomised controlled trials (RCTs) reporting sedation-related adverse event incidence when adding capnography to visual assessment and pulse oximetry in patients undergoing PSA during ambulatory surgery in the hospital setting. Searches for eligible studies published between 1 January 1995 and 31 December 2016 (inclusive) were conducted in PubMed, the Cochrane Library and EMBASE without any language constraints. Searches were conducted in January 2017, screening and data extraction were conducted by two independent reviewers, and study quality was assessed using a modified Jadad scale. INTERVENTIONS: Capnography monitoring relative to visual assessment and pulse oximetry alone. PRIMARY AND SECONDARY OUTCOME MEASURES: Predefined endpoints of interest were desaturation/hypoxaemia (the primary endpoint), apnoea, aspiration, bradycardia, hypotension, premature procedure termination, respiratory failure, use of assisted/bag-mask ventilation and death during PSA. RESULTS: The literature search identified 1006 unique articles, of which 13 were ultimately included in the meta-analysis. Addition of capnography to visual assessment and pulse oximetry was associated with a significant reduction in mild (risk ratio (RR) 0.77, 95% CI 0.67 to 0.89) and severe (RR 0.59, 95% CI 0.43 to 0.81) desaturation, as well as in the use of assisted ventilation (OR 0.47, 95% CI 0.23 to 0.95). No significant differences in other endpoints were identified. CONCLUSIONS: Meta-analysis of 13 RCTs published between 2006 and 2016 showed a reduction in respiratory compromise (from respiratory insufficiency to failure) during PSA with the inclusion of capnography monitoring. In particular, use of capnography was associated with less mild and severe oxygen desaturation, which may have helped to avoid the need for assisted ventilation

Clinical and economic burden of procedural sedation-related adverse events and their outcomes: analysis from five countries

Background: Studies have reported on the incidence of sedation-related adverse events (AEs), but little is known about their impact on health care costs and resource use. Methods: Health care providers and payers in five countries were recruited for an online survey by independent administrators to ensure that investigators and respondents were blinded to each other. Surveys were conducted in the local language and began with a screener to ensure that respondents had relevant expertise and experience. Responses were analyzed using Excel and R, with the Dixon\u27s Q statistic used to identify and remove outliers. Global and country-specific average treatment patterns were calculated via bootstrapping; costs were mean values. The sum product of costs and intervention probability gave a cost per AE. Results: Responses were received from 101 providers and 26 payers, the majority having \u3e 5 years of experience. At a minimum, the respondents performed a total of 3,430 procedural sedations per month. All AEs detailed occurred in clinical practice in the last year and were reported to cause procedural delays and cancellations in some patients. Standard procedural sedation costs ranged from euro74 (Germany) to $2,300 (US). Respondents estimated that AEs would increase costs by between 16$43 ($27-$68). Other frequent AEs, including mild hypotension, bradycardia, tachycardia, mild oxygen desaturation, hypertension, and brief apnea, were estimated to increase health care spending on procedural sedation by $2.2 billion annually in the US. Conclusion: All sedation-related AEs can increase health care costs and result in substantial delays or cancellations of subsequent procedures. The prevention of even minor AEs during procedural sedation may be crucial to ensuring its value as a health care service

Use of the i2b2 research query tool to conduct a matched case–control clinical research study: advantages, disadvantages and methodological considerations

Background: A major aim of the i2b2 (informatics for integrating biology and the bedside) clinical data informatics framework aims to create an efficient structure within which patients can be identified for clinical and translational research projects. Our objective was to describe the respective roles of the i2b2 research query tool and the electronic medical record (EMR) in conducting a case-controlled clinical study at our institution. Methods: We analyzed the process of using i2b2 and the EMR together to generate a complete research database for a case–control study that sought to examine risk factors for kidney stones among gastrostomy tube (G-tube) fed children. Results: Our final case cohort consisted of 41/177 (23%) of potential cases initially identified by i2b2, who were matched with 80/486 (17%) of potential controls. Cases were 10 times more likely to be excluded for inaccurate coding regarding stones vs. inaccurate coding regarding G-tubes. A majority (67%) of cases were excluded due to not meeting clinical inclusion criteria, whereas a majority of control exclusions (72%) occurred due to inadequate clinical data necessary for study completion. Full dataset assembly required complementary information from i2b2 and the EMR. Conclusions: i2b2 was critical as a query analysis tool for patient identification in our case–control study. Patient identification via procedural coding appeared more accurate compared with diagnosis coding. Completion of our investigation required iterative interplay of i2b2 and the EMR to assemble the study cohort

Correlation of endoscopic disease severity with pediatric ulcerative colitis activity index score in children and young adults with ulcerative colitis

AIM: To investigate of pediatric ulcerative colitis activity index (PUCAI) in ulcerative colitis correlate with mucosal inflammation and endoscopic assessment of disease activity (Mayo endoscopic score). METHODS: We reviewed charts from ulcerative colitis patients who had undergone both colonoscopy over 3 years. Clinical assessment of disease severity within 35 d (either before or after) the colonoscopy were included. Patients were excluded if they had significant therapeutic interventions (such as the start of corticosteroids or immunosuppressive agents) between the colonoscopy and the clinical assessment. Mayo endoscopic score of the rectum and sigmoid were done by two gastroenterologists. Inter-observer variability in Mayo score was assessed. RESULTS: We identified 99 patients (53% female, 74% pancolitis) that met inclusion criteria. The indications for colonoscopy included ongoing disease activity (62%), consideration of medication change (10%), assessment of medication efficacy (14%), and cancer screening (14%). Based on PUCAI scores, 33% of patients were in remission, 39% had mild disease, 23% had moderate disease, and 4% had severe disease. There was moderate-substantial agreement between the two reviewers in assessing rectal Mayo scores (kappa = 0.54, 95%CI: 0.41-0.68). CONCLUSION: Endoscopic disease severity (Mayo score) assessed by reviewing photographs of pediatric colonoscopy has moderate inter-rater reliability, and agreement was less robust in assessing patients with mild disease activity. Endoscopic disease severity generally correlates with clinical disease severity as measured by PUCAI score. However, children with inflamed colons can have significant variation in their reported clinical symptoms. Thus, assessment of both clinical symptoms and endoscopic disease severity may be required in future clinical studies

A Pilot Study of Ketamine versus Midazolam/Fentanyl Sedation in Children Undergoing GI Endoscopy

Background. Ketamine sedation has been found superior by physician report to traditional sedation regimens for pediatric endoscopy. Goal. To objectively compare sedation with ketamine versus midazolam/fentanyl for children undergoing gastrointestinal endoscopy. Study. Patients received one of two regimens and were independently monitored using a standardized rating scale. Results. There were 2 episodes of laryngospasm during ketamine sedation. Univariate analyses showed patients sedated with ketamine (n = 17) moved more (median 25% of procedure time versus 8%, P = .03) and required similar low levels of restraint (0.83% versus 0.25%, P = .4) as patients sedated with midazolam/fentanyl (n = 20). Age-adjusted analyses suggested that patients sedated with ketamine were comparably more quiet (P = .002). Conclusions. A pilot trial of ketamine at our institution was associated with episodes of laryngospasm. In addition, children sedated with ketamine moved and required restraint similarly to patients sedated with midazolam/fentanyl. Physician perceptions may be affected by the fact that children who received ketamine were less likely to vocalize distress

The Gut Speaks: Reframing the Role of Pediatric Gastroenterologists Caring for Children With Autism and Gastrointestinal Symptoms

Commentary on: Kushak RI, Buie TM, Murray KF, et al. Evaluation of intestinal function in children with autism and gastrointestinal symptoms. J Pediatr Gastroenterol Nutr 2016;62:687–91

Vomiting in Children

Vomiting is a common symptom of numerous underlying conditions for which children frequently present for healthcare. Although vomiting can originate from the gastrointestinal (GI) tract itself, it can also signal more generalized, systemic disorders. Vomiting in children is often benign and can be managed with supportive measures only. Still, clinicians must be able to recognize life-threatening causes of vomiting and to avoid serious associated complications, including electrolyte abnormalities, dehydration, or even bowel necrosis

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as the avoidance of physical or psychological harm. A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses

Adverse events associated with ERCP

This is one of a series of statements discussing the use of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy (ASGE) prepared this text

Variation in Pediatric Anesthesiologist Sedation Practices for Pediatric Gastrointestinal Endoscopy

Background: Despite a worldwide shift toward anesthesiologist-administered sedation for gastrointestinal endoscopy in children, ideal sedation regimens remain unclear and best practices undefined. Aim: The aim of our study was to document variation in anesthesiologist-administered sedation for pediatric endoscopy. Outcomes of interest included coefficients of variation, procedural efficiency, as well as adverse events. Methods: IRB approval was obtained to review electronic health records of children undergoing routine endoscopy at our medical center during a recent calendar year. Descriptive and multivariate analyses were used to examine predictors of sedation practices. Results: 258 healthy children [2-21 years (median 15, (Q1-Q3 = 10-17)] underwent either upper and/or lower endoscopies with sedation administered by anesthesiologists (n = 21), using different sedation regimens (29) that ranged from a single drug administered to 6 sedatives in combination. Most patients did not undergo endotracheal tube intubation for the procedure (208, 81%), and received propofol (255, 89%) either alone or in combination with other sedatives. A total of 10 (3.8%) adverse events (9 sedation related) were documented to occur. The coefficient of variation (CV) for sedation times was high at 64.2%, with regression analysis suggesting 8% was unexplained by procedure time. Multivariable model suggested that longer procedure time (p \u3c 0.0001), younger age (p \u3c 0.0001), and use of endotracheal tube intubation (p = 0.02) were associated with longer sedation time. Discussion: We found great variation in anesthesiologist administered regimens for pediatric endoscopy at our institution that may be unwarranted, presenting may opportunities for minimizing patient risk, as well as for optimizing procedural efficiency