Prevention of tracheal cartilage injury with modified Griggs technique during percutaneous tracheostomy - Randomized controlled cadaver study

Introduction: Tracheal stenosis is the most common severe late complication of percutaneous tracheostomy causing significant decrease in quality of life. Applying modified Griggs technique reduced the number of late tracheal stenoses observed in our clinical study. The aim of this study was to investigate the mechanism of this relationship. Materials and methods: Forty-six cadavers were randomized into two groups according to the mode of intervention during 2006-2008. Traditional versus modified Griggs technique was applied in the two groups consequently. Wider incision, surgical preparation, and bidirectional forceps dilation of tracheal wall were applied in modified technique. Injured cartilages were inspected by sight and touch consequently. Age, gender, level of intervention, and number of injured tracheal cartilages were registered. Results: Significantly less frequent tracheal cartilage injury was observed after modified (9%) than original (91%) Griggs technique (p<0.001). A moderate association between cartilage injury and increasing age was observed, whereas the level of intervention (p=0.445) and to gender (p=0.35) was not related to injury. Risk of cartilage injury decreased significantly (OR: 0.0264, 95%, CI: 0.005-0.153) with modified Griggs technique as determined in adjusted logistic regression model. Discussion: Modified Griggs technique decreased the risk of tracheal cartilage injury significantly in our cadaver study. This observation may explain the decreased number of late tracheal stenosis after application of the modified Griggs method. © 2012 Akadémiai Kiadó, Budapes

Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study)

Purpose The CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing ~ 23% immunoglobulin (Ig) M, ~ 21% IgA, and ~ 56% IgG as add-on therapy for patients with severe community-acquired pneumonia (sCAP). Methods In this double-blind, phase II study (NCT01420744), 160 patients with sCAP requiring invasive mechanical ventilation were randomized (1:1) to trimodulin (42 mg IgM/kg/day) or placebo for five consecutive days. Primary endpoint was ventilator-free days (VFDs). Secondary endpoints included 28-day all-cause and pneumonia-related mortality. Safety and tolerability were monitored. Exploratory post hoc analyses were performed in subsets stratified by baseline C-reactive protein (CRP; ≥ 70 mg/L) and/or IgM (≤ 0.8 g/L). Results Overall, there was no statistically significant difference in VFDs between trimodulin (mean 11.0, median 11 [n = 81]) and placebo (mean 9.6; median 8 [n = 79]; p = 0.173). Twenty-eight-day all-cause mortality was 22.2% vs. 27.8%, respectively (p = 0.465). Time to discharge from intensive care unit and mean duration of hospitalization were comparable between groups. Adverse-event incidences were comparable. Post hoc subset analyses, which included the majority of patients (58–78%), showed significant reductions in all-cause mortality (trimodulin vs. placebo) in patients with high CRP, low IgM, and high CRP/low IgM at baseline. Conclusions No significant differences were found in VFDs and mortality between trimodulin and placebo groups. Post hoc analyses supported improved outcome regarding mortality with trimodulin in subsets of patients with elevated CRP, reduced IgM, or both. These findings warrant further investigation