SummaryFifty female patients were studied to compare the view of the larynx at direct laryngoscopy under general anaesthesia with and without cricoid pressure applied. We also compared the view using the standard technique of cricoid pressure with that using cricoid pressure in an upward and backward direction and further investigated whether these views were improved with a firm foam rubber neck support. The order in which the types of cricoid pressure were applied was randomised and also blinded with a drape over the neck. Cricoid pressure was simulated on weighing scales after each case and a mean force of 3.2 kg was applied. The majority of views at laryngoscopy (95%) were grade 1, with too few grade 2 and 3 views for statistical comparison. Both types of cricoid pressure applied without neck support were more likely to give a better view than no cricoid pressure (p < 0.01) and cricoid pressure in an upward and backward direction was more likely to give a better view at laryngoscopy than the standard technique (p < 0.01). Neck support during the standard technique of cricoid pressure did not improve the view of the larynx at laryngoscopy. Cricoid pressure is likely to improve the view at laryngoscopy which may be further improved by applying it in an upward and backward direction.Keywords Larynx; cricoid pressure. Intubation; tracheal. ...................................................................................... Correspondence to: R. G. Vanner Accepted: 17 February 1997 Cricoid pressure is routinely used to prevent regurgitation of gastric contents into the pharynx during the induction of general anaesthesia in all the Maternity Units recently surveyed in the UK [1]. However, it has been suggested that the use of cricoid pressure may make tracheal intubation more difficult [2, 3]. It is not clear whether poor technique alone is responsible or whether correctly applied cricoid pressure may also cause difficulty with intubation. Although it is well known that a degree of pressure on the front of the larynx can improve the view at laryngoscopy [4] it is not known whether correctly applied cricoid pressure, at a force that would prevent regurgitation, alters the view at laryngoscopy.Neck support has been recommended to improve the view at laryngoscopy during the application of cricoid pressure by preventing the head flexing on the neck, either with a bimanual technique [5] or with a cuboid of foam rubber [6]. Bimanual cricoid pressure has been adopted widely [1, 7] despite the lack of evidence supporting this hypothesis; indeed one recent study showed no improvement in the view at laryngoscopy when comparing bimanual with single handed cricoid pressure [8].If the arch of the cricoid cartilage is pushed in an upward (cephalad) direction [9], or the whole larynx is moved in an upward direction [10, 11], the view at laryngoscopy is improved compared with the view with no external manipulation. Therefore, cricoid pressure applied in an upward and backward direction with enough force to prevent reg...

BackgroundFKB327 is a proposed biosimilar of the adalimumab reference product (ADL). This randomised, double-blind, Phase III study (NCT02260791; FKB327-002) evaluated the therapeutic equivalence of FKB327 and ADL in patients (pts) with active rheumatoid arthritis (RA) inadequately controlled on methotrexate (MTX).ObjectivesTo assess the efficacy, safety, pharmacokinetics (PK) and immunogenicity of FKB327 compared with ADL in pts with active RA.MethodsPts aged ≥18 years with moderate to severe, active RA for ≥3 months and taking MTX for ≥3 months (10–25 mg/week [wk] stable dose for ≥8 wks) were enrolled. Pts were randomised 1:1 to receive FKB327 or ADL (40 mg subcutaneous injection) every 2 wks with continuing MTX, stratified by prior biologic treatment (yes/no) and screening disease activity (Disease Activity Score 28 using C-reactive protein [DAS28-CRP] ≤5.1/>5.1). The primary efficacy endpoint was American College of Rheumatology (ACR) 20 response rate at Wk 24; equivalence margins of ±13% were prespecified for a two-sided 95% confidence interval (CI) based on ADL treatment effect in previous studies. Secondary endpoints included ACR20 response rate over time, DAS28-CRP at Wk 24 and over time. Safety was assessed by the incidence/severity of adverse events (AEs) and laboratory abnormalities.Results730 pts from 105 sites in 12 countries were randomised; 728 pts were treated with either FKB327 (n=366) or ADL (n=362). Demographics and baseline RA characteristics were comparable between the groups, with overall mean age of 55.3 years, mean DAS28-CRP score of 6.1 and mean MTX dose of 15.7 mg/wk. ACR20 response rates at Wk 24 (full analysis set) were comparable between the FKB327 (270/363; 74.4%) and ADL groups (271/358; 75.7%). 95% CIs for treatment difference (FKB327 – ADL: −7.6 to 5.0) fell within the ±13% equivalence margins, meeting the primary study objective. ACR20 response rates over time overlapped during Wks 4–24 (Figure 1). Least squares mean DAS28-CRP at Wk 24 were 3.43 on FKB327 and 3.42 on ADL and were equivalent using prespecified margins; changes in scores over time were also comparable. The proportions of pts reporting treatment-emergent AEs (TEAEs) on FKB327 or ADL were similar (FKB327 55.5% vs ADL 61.6%); AEs were mainly mild or moderate. The most common TEAEs (≥5%) were nasopharyngitis (7.1% vs 8.0%) and upper respiratory tract infection (3.6% vs 5.0%). Incidences of serious AEs were similar (4.1% vs 5.2%). One death due to treatment-related disseminated tuberculosis (TB) was reported in the FKB327 group; reports of active TB were slightly higher with ADL (1 vs 3 pts). Mean serum trough concentration-time profiles of the two groups were comparable. The prevalence and titres of antidrug antibodies (ADA) were similar, including at final sampling (57.9% vs 55.8%).Figure 1ConclusionsThe study met its prespecified equivalency endpoint for ACR20 response rate at Wk 24, with comparable rates over time. Safety profiles, ADA formation and PK were also similar, supporting the comparability of FKB327 and ADL...

BackgroundThe introduction of central venous catheters has advanced medical care, particularly in hemato-oncology. However these can be associated with an increased thrombotic risk. Previous studies have compared the rate of thrombotic events between peripherally- inserted (PICCs) and long term skin tunneled catheters (LTSTCs) noting fewer complications associated with the latter, though this has rarely translated into clinical practice. The objectives of our study was to compare the cumulative incidence of thrombotic events between peripherally-inserted and long term skin tunneled venous catheters.Patients/methodsWe performed a retrospective, single center cohort analysis of patients with hematological malignancies who had either a PICC or LTSTC line inserted between January 2010 through January 2013. Cumulative incidences of thrombotic events were compared between the two groups, and post-thrombotic complications were also examined.Results346 patients had a PICC inserted with cumulative incidence of symptomatic thrombosis of 5.8%, while 237 patients had a LTSTC inserted with a cumulative incidence of 1.7% (p = 0.003). Post-thrombotic complication rates, particularly infection, were higher in the PICC group compared to the LTSTC group (p = 0.597).ConclusionsOur study showed that the incidence of thrombotic events in hemato-oncology patients was significantly lower in those who had a LTSTC compared to PICC line. As the use of central venous lines increases in hemato-oncology patient care, a randomized trial comparing PICCs and LTSTCs is necessary to address which venous access is most appropriate in this cohort of patients, with minimal risk of morbidity and mortality.

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