Insufflation vs intubation during esophagogastroduodenoscopy in children

Objectives: We compared adverse airway events during esophagogastroduodenoscopy (EGD) in children managed with insufflation vs intubation. Background: Optimum airway management during EGD in children remains undecided. Methods/materials: Following IRB approval and written informed parental consent, children between 1 and 12 years of age presenting for EGD were randomized to airway management with insufflation (Group I), intubation/awake extubation (Group A), or intubation/deep extubation (Group D). All subjects received a standardized anesthetic with sevoflurane in oxygen. Using uniform definitions, airway adverse events during and after EGD recovery were recorded. Categorical data were analysed with Chi‐square contingency tables or Fisher’s exact test as appropriate. Results: Analyzable data were available for 415 subjects (Group I: 209; Group A: 101; Group D: 105). Desaturation, laryngospasm, any airway adverse event, and multiple airway adverse events during EGD were significantly more common in subjects in Group I compared to those in Groups A and D. Complaints of sore throat, hoarseness, stridor, and/or dysphagia were more common in subjects in Groups A and D. Analysis of confounders suggested that younger age, obesity, and midazolam premedication were independent predictors of airway adverse events during EGD. Conclusions: Insufflation during EGD was associated with a higher incidence of airway adverse events, including desaturation and laryngospasm; intubation during EGD was associated with more frequent complaints related to sore throat. As our results show that insufflation during EGD offers no advantage in terms of operational efficiency and is associated with more airway adverse events, we recommend endotracheal intubation during EGD, especially in patients who are younger, obese, or have received midazolam premedication.     

Choice of Vein‐Harvest Technique for Coronary Artery Bypass Grafting: Rationale and Design of the REGROUP Trial

The Randomized Endo‐vein Graft Prospective (REGROUP) trial ( ClinicalTrials.gov  NCT01850082) is a randomized, intent‐to‐treat, 2‐arm, parallel‐design, multicenter study funded by the Cooperative Studies Program (CSP No. 588) of the US Department of Veterans Affairs. Cardiac surgeons at 16 Veterans Affairs (VA) medical centers with technical expertise in performing both endoscopic vein harvesting (EVH) and open vein harvesting (OVH) were recruited as the REGROUP surgeon participants. Subjects requiring elective or urgent coronary artery bypass grafting using cardiopulmonary bypass with use of ≥1 saphenous vein graft will be screened for enrollment using pre‐established inclusion/exclusion criteria. Enrolled subjects (planned N = 1150) will be randomized to 1 of the 2 arms (EVH or OVH) after an experienced vein harvester has been assigned. The primary outcomes measure is the rate of major adverse cardiac events (MACE), including death, myocardial infarction, or revascularization. Subject assessments will be performed at multiple times, including at baseline, intraoperatively, postoperatively, and at discharge (or 30 days after surgery, if still hospitalized). Assessment of leg‐wound complications will be completed at 6 weeks after surgery. Telephone follow‐ups will occur at 3‐month intervals after surgery until the participating sites are decommissioned after the trial's completion (approximately 4.5 years after the full study startup). To assess long‐term outcomes, centralized follow‐up of MACE for 2 additional years will be centrally performed using VA and non‐VA clinical and administrative databases. The primary MACE outcome will be compared between the 2 arms, EVH and OVH, at the end of the trial duration.     

Interventional cardiology live case presentations: Regulatory considerations

Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion. © 2010 Wiley‐Liss, Inc.     

Better Function for Fusions Versus Above-the-knee Amputations for Recurrent Periprosthetic Knee Infection

Background  

Treatment of chronic periprosthetic joint infections (PJIs) after TKA is limited to fusions, above-the-knee amputations (AKAs), revision TKA, and antibiotic suppression and is often based on the patient’s medical condition. However, when both fusion and AKA are options, it is important to compare these two procedures with regard to function.