Summary Background Primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction has traditionally been supported by unfractionated heparin, which has never been directly ...compared with a new anticoagulant using consistent anticoagulation and similar antiplatelet strategies in both groups. We compared traditional heparin treatment with intravenous enoxaparin in primary PCI. Methods In a randomised open-label trial, patients presenting with ST-elevation myocardial infarction were randomly assigned (1:1) to receive an intravenous bolus of 0·5 mg/kg of enoxaparin or unfractionated heparin before primary PCI. Wherever possible, medical teams travelling in mobile intensive care units (ambulances) selected, randomly assigned (using an interactive voice response system at the central randomisation centre), and treated patients. Patients who had received any anticoagulant before randomisation were excluded. Patients and caregivers were not masked to treatment allocation. The primary endpoint was 30-day incidence of death, complication of myocardial infarction, procedure failure, or major bleeding. The main secondary endpoint was the composite of death, recurrent acute coronary syndrome, or urgent revascularisation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov , number NCT00718471. Findings 910 patients were assigned to treatment with enoxaparin (n=450) or unfractionated heparin (n=460). The primary endpoint occurred in 126 (28%) patients after anticoagulation with enoxaparin versus 155 (34%) patients on unfractionated heparin (relative risk RR 0·83, 95% CI 0·68–1·01, p=0·06). The incidence of death (enoxaparin, 17 4% vs heparin, 29 6% patients; p=0·08), complication of myocardial infarction (20 4% vs 29 6%; p=0·21), procedure failure (100 26% vs 109 28%; p=0·61), and major bleeding (20 5% vs 22 5%; p=0·79) did not differ between groups. Enoxaparin resulted in a significantly reduced rate of the main secondary endpoint (30 7% vs 52 11% patients; RR 0·59, 95% CI 0·38–0·91, p=0·015). Death, complication of myocardial infarction, or major bleeding (46 10% vs 69 15% patients; p=0·03), death or complication of myocardial infarction (35 8% vs 57 12%; p=0·02), and death, recurrent myocardial infarction, or urgent revascularisation (23 5% vs 39 8%; p=0·04) were all reduced with enoxaparin. Interpretation Intravenous enoxaparin compared with unfractionated heparin significantly reduced clinical ischaemic outcomes without differences in bleeding and procedural success. Therefore, enoxaparin provided an improvement in net clinical benefit in patients undergoing primary PCI. Funding Direction de la Recherche Clinique, Assistance Publique-Hôpitaux de Paris; Sanofi-Aventis.
Summary Background Critically ill patients often require emergency intubation. The use of etomidate as the sedative agent in this context has been challenged because it might cause a reversible ...adrenal insufficiency, potentially associated with increased in-hospital morbidity. We compared early and 28-day morbidity after a single dose of etomidate or ketamine used for emergency endotracheal intubation of critically ill patients. Methods In this randomised, controlled, single-blind trial, 655 patients who needed sedation for emergency intubation were prospectively enrolled from 12 emergency medical services or emergency departments and 65 intensive care units in France. Patients were randomly assigned by a computerised random-number generator list to receive 0·3 mg/kg of etomidate (n=328) or 2 mg/kg of ketamine (n=327) for intubation. Only the emergency physician enrolling patients was aware of group assignment. The primary endpoint was the maximum score of the sequential organ failure assessment during the first 3 days in the intensive care unit. We excluded from the analysis patients who died before reaching the hospital or those discharged from the intensive care unit before 3 days (modified intention to treat). This trial is registered with ClinicalTrials.gov , number NCT00440102. Findings 234 patients were analysed in the etomidate group and 235 in the ketamine group. The mean maximum SOFA score between the two groups did not differ significantly (10·3 SD 3·7 for etomidate vs 9·6 3·9 for ketamine; mean difference 0·7 95% CI 0·0–1·4, p=0·056). Intubation conditions did not differ significantly between the two groups (median intubation difficulty score 1 IQR 0–3 in both groups; p=0·70). The percentage of patients with adrenal insufficiency was significantly higher in the etomidate group than in the ketamine group (OR 6·7, 3·5–12·7). We recorded no serious adverse events with either study drug. Interpretation Our results show that ketamine is a safe and valuable alternative to etomidate for endotracheal intubation in critically ill patients, and should be considered in those with sepsis. Funding French Ministry of Health.
Abstract Objective The aim of the study was to compare in emergency settings 2 analgesic regimens, morphine with ketamine (K group) or morphine with placebo (P group), for severe acute pain in trauma ...patients. Methods This was a prospective, multicenter, randomized, double-blind, clinical trial. Seventy-three trauma patients with a severe acute pain defined as a visual analog scale (VAS) score of at least 60/100 were enrolled. Patients in the K group received 0.2 mg · kg−1 of intravenous ketamine over 10 minutes, and patients in the P group received isotonic sodium chloride solution. In both groups, patients were given an initial intravenous morphine injection of 0.1 mg · kg−1 , followed by 3 mg every 5 minutes. Efficient analgesia was defined as a VAS score not exceeding 30/100. The primary end points were morphine consumption and VAS at 30 minutes (T30). Results At T30, morphine consumption was significantly lower in the K group vs the P group, with 0.149 mg · kg−1 (0.132-0.165) and 0.202 mg · kg−1 (0.181-0.223), respectively ( P < .001). The VAS score at T30 did not differ significantly between the 2 groups, with 34.1 (25.6-42.6) in the K group and 39.5 (32.4-46.6) in the P group ( P = not significant). Conclusion Ketamine was able to provide a morphine-sparing effect.
Study objective Emergency tracheal intubation is reported to be more difficult with single-use plastic than with reusable metal laryngoscope blades in both inhospital and out-of-hospital settings. ...Single-use metal blades have been developed but have not been compared with conventional metal blades. This controlled trial compares the efficacy and safety of single-use metal blades with reusable metal blades in out-of-hospital emergency tracheal intubation. Methods This randomized controlled trial was carried out in France with out-of-hospital emergency medical units (Services de Médecine d'Urgence et de Réanimation). This was a multicenter prospective noninferiority randomized controlled trial in adult out-of-hospital patients requiring emergency tracheal intubation. Patients were randomly assigned to either single-use or reusable metal laryngoscope blades and intubated by a senior physician or a nurse anesthetist. The primary outcome was first-pass intubation success. Secondary outcomes were incidence of difficult intubation, need for alternate airway devices, and early intubation-related complications (esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest). Results The study included 817 patients, including 409 intubated with single-use blades and 408 with a reusable blade. First-pass intubation success was similar in both groups: 292 (71.4%) for single-use blades, 290 (71.1%) for reusable blades. The 95% confidence interval (CI) for the difference in treatments (0.3%; 95% CI –5.9% to 6.5%) did not include the prespecified inferiority margin of –7%. There was no difference in rate of difficult intubation (difference 3%; 95% CI –7% to 2%), need for alternate airway (difference 4%; 95% CI –8% to 1%), or early complication rate (difference 3%; 95% CI –3% to 8%). Conclusion First-pass out-of-hospital tracheal intubation success with single-use metal laryngoscopy blades was noninferior to first-pass success with reusable metal laryngoscope blades.
Abstract Objective The objective was to assess agreement between end-tidal carbon dioxide values measured by a handheld capnometer (P etco2 ) and values measured by a blood gas analyzer (Pa co2 ) in ...nonintubated patients with respiratory distress in an out-of-hospital setting. Methods This prospective study compared P etco2 values obtained by an end-tidal capnometer (Microcap Plus; Oridion Capnography Inc, Needham, Mass) to Pa co2 values by the Bland and Altman statistical method. Results A total of 50 patients were included. Continuous P etco2 monitoring was easily performed in all 50 patients during ambulance transport, but blood gas analysis failed in 1 patient. Agreement between the 2 methods was poor with a bias (mean difference) between P etco2 and Pa co2 measurements of 12 mm Hg and a precision (SD of the difference) of 8 mm Hg. The gradient between P etco2 and Pa co2 was greater than 5 and 10 mm Hg in 41 and 25 patients, respectively. Conclusions P etco2 measurements poorly reflected Pa co2 values in our population of nonintubated patients with respiratory distress of various origins.
Study objective The objective of this study was to compare, in the emergency out-of-hospital environment, intubation success rates during the first laryngoscopy for 2 laryngoscope blade types: a ...metallic reusable and a plastic single-use. Methods An observational before-and-after study was conducted during 2 1-year periods. Adult patients were intubated by emergency physicians, anesthesiologists, or anesthesia nurses in the out-of-hospital setting with metallic reusable (first period) or a plastic disposable (second period) Macintosh 3 or 4 laryngoscope blades. Immediately after intubation, data were collected on success rate of intubation at the first attempt, intubation difficulty score, quality of laryngeal visualization, and the need for alternative airway techniques. To compare the 2 periods of the study, Wilcoxon’s test was used for quantitative variables, and the χ2 or Fisher’s exact test was used for qualitative variables. Results Patients intubated with a metallic blade (594/1,177; 50.5%) and with a plastic blade (583/1,177; 49.5%) were included in the study. The first-attempt intubation success rate was higher in the metallic blade group (497/594, 84%) than in the single-use group (76%); difference 7% (95% confidence interval CI 3% to 12%) ( P <.002). The incidence of difficult intubation, defined by an intubation difficulty score greater than 5, was lower (6% 95% CI 4% to 8% versus 15% 95% CI 12% to 18%) when metallic blades were used. A good laryngeal view (Cormack and Lehane classes I and II) was more frequently observed with metallic blade use (83% 95% CI 80% to 86% versus 67% 95% CI 64% to 70%). Alternative airway techniques such as the use of a Gum elastic bougie or an intubating laryngeal mask airway were more frequently used in the plastic blade period (12% 95% CI 10% to 14% versus 4% 95% CI 2% to 6%). Conclusion In out-of-hospital emergency care, the use of a plastic disposable laryngoscope blade decreased the success rate of tracheal intubation at the first attempt performed by emergency care providers.
Abstract Study Objective To compare two brands of disposable plastic laryngoscope blades, Vital View plastic blades and Heine XP plastic blades, with the reusable Heine Classic+ Macintosh metal ...blades. Design Prospective randomized, controlled, single-blinded study. Setting Operating room of a university-affiliated hospital. Patients 519 patients without criteria for predicted difficult intubation, undergoing scheduled surgery during general anesthesia. Interventions Patients were randomized to three groups according to laryngoscope blade brand. Measurements Difficult tracheal intubation was evaluated by the Intubation Difficulty Scale (IDS) (IDS > 5 = procedure involving moderate to major difficulty). Main Results The percentage of intubations with an IDS > 5 was 3.1% in Group M (metal blade group), 5.1% in Group V (Vital View plastic blade group), and 10.0% in Group H (Heine plastic blade group). A significant difference was noted between Groups M and H ( P = 0.02) but not between Groups M and V. Conclusions Intubation may be more challenging when using Heine XP plastic blades but no significant difference exists between Vital-View plastic blades and Heine Classic+ metal blades.
Abstract Objective Out-of-hospital clinical experience with noninvasive bilevel positive airway pressure (BiPAP) ventilation is extremely limited compared to inhospital management. The aims of this ...study were to assess the feasibility of out-of-hospital BiPAP ventilation in patients with acute respiratory distress of various origins, and to look for specific factors associated with failure of this respiratory support. Methods This 2-year prospective observational study assessed the failure rate of out-of-hospital BiPAP ventilation, the difficulties encountered, and factors predictive of failure by multivariate analysis. Results Overall, 138 patients were treated by out-of-hospital BiPAP for congestive heart failure (56%), chronic obstructive pulmonary disease exacerbation (28%), and acute respiratory failure (16%). Failure rate was 26% (35/138; 95% confidence interval, 18%-33%) (11 before and 24 after reaching hospital). Independent risk factors were the cause of respiratory distress (chronic obstructive pulmonary disease exacerbation; acute respiratory failure) and an audible air leakage. Conclusions The failure rate of BiPAP initiated out-of-hospital was no different from previous reports for inhospital failure rates. Failure was attributable to similar causes.
