In May 2009 for financial reasons, the epoetin product used for hemoglobin (Hb) maintenance in our renal dialysis unit was changed from epoetin beta to epoetin alfa. Although widely believed that the dosage requirements are the same, we undertook a retrospective analysis to investigate whether the dosage requirements in chronic renal failure patients were comparable for both preparations. We studied 128 stable end-stage renal failure patients on hemodialysis (three times per week) receiving erythropoietin therapy to maintain their Hb at 11-12.5 g/dL. Patients were excluded if within the study period they developed signs of infection, bleeding, required blood transfusion, were under-dialyzed, or required hospital admission. Regular monthly Hb concentrations and hematocrit (Hct) levels were measured for each patient. The weekly EPO index (defined as weekly epoetin dose/mean monthly Hct) was derived for each patient, before and after regime change. Of the 128 patients in end-stage renal failure, 79 were included in the study. There was no significant difference between the two preparations in terms of Hct level achieved (p = 0.15). However, the median weekly epoetin dose requirement increased from 6733 (range 750-30,000) IU/week to 9000 (250-30,667) IU/week (p < 0.001). EPO index similarly increased from 20,465 (2500-130,846) IU/week/% to 27,073 (729-98,937) IU/week/% (p < 0.001). Our study showed that a higher dose of epoetin alfa was needed to maintain target Hb concentration.
Both intraoperative peak inspiratory pressure and FiO are independent factors significantly associated with development of a postoperative pulmonary complication in emergency laparotomy patients. Further studies are required to identify causality and to demonstrate if their manipulation could lead to better clinical outcomes.
Introduction
Most trials comparing effectiveness of laryngoscopy technique use surrogate endpoints. Intubation success is a more appropriate endpoint for comparing effectiveness of techniques or devices. A large pragmatic clinical trial powered for intubation success has not yet been performed.
Methods
We tested the feasibility of a randomised controlled trial to compare the performance of direct laryngoscopy versus videolaryngoscopy for endotracheal intubation. The trial was conducted in the Department of Adult and Emergency Anaesthesia at the Auckland City Hospital, New Zealand. Patients over 18 years who required endotracheal intubation and were not known or predicted to be difficult to bag-mask ventilate were eligible for the study. Patients were excluded if they required rapid sequence induction, fibreoptic intubation or were unable to consent due to language barriers or cognitive impairment.
Patients were permuted block randomised in groups of 8 to either direct laryngoscopy (DL) or videolaryngoscopy (VL) for the technique of endotracheal intubation. Patients were blinded to laryngoscopic technique; the duty anaesthetist, outcome assessors and statistician were unblinded.
Feasibility was assessed on recruitment rate, adherence to group assignment and data completeness. Primary outcome was first-pass success rate, with secondary outcomes of time to intubation (seconds), Intubation Difficulty Score and complication rate.
Results
One hundred and six patients were randomised and 100 patient results were analysed. Completed data from patients randomised to the DL group (
n
= 49) was compared with those in the VL group (
n
= 51). Group adherence and data completeness were 100% and 97%, respectively. First-pass success rate was 83.7% in the direct laryngoscopy group and 72.5% in the videolaryngoscopy group (
p
= 0.18). Median time to intubation was significantly shorter for direct laryngoscopy when compared to videolaryngoscopy (34 s v 43 s,
p
= 0.038). Complications included mucosal trauma and airway bleeding which are recognised complications of endotracheal intubation.
Conclusion
A large, pragmatic, multicentre, randomised controlled trial comparing the relative effectiveness of direct laryngoscopy and indirect videolaryngoscopy is feasible.
Trial registration
Australian New Zealand Clinical Trials Registry (ANZCTR),
ACTRN12615001267549
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