Effect of Trans-Nasal Evaporative Intra-arrest Cooling on Functional Neurologic Outcome in Out-of-Hospital Cardiac Arrest : The PRINCESS Randomized Clinical Trial

© 2019 American Medical Association. All rights reserved.Importance: Therapeutic hypothermia may increase survival with good neurologic outcome after cardiac arrest. Trans-nasal evaporative cooling is a method used to induce cooling, primarily of the brain, during cardiopulmonary resuscitation (ie, intra-arrest). Objective: To determine whether prehospital trans-nasal evaporative intra-arrest cooling improves survival with good neurologic outcome compared with cooling initiated after hospital arrival. Design, Setting, and Participants: The PRINCESS trial was an investigator-initiated, randomized, clinical, international multicenter study with blinded assessment of the outcome, performed by emergency medical services in 7 European countries from July 2010 to January 2018, with final follow-up on April 29, 2018. In total, 677 patients with bystander-witnessed out-of-hospital cardiac arrest were enrolled. Interventions: Patients were randomly assigned to receive trans-nasal evaporative intra-arrest cooling (n = 343) or standard care (n = 334). Patients admitted to the hospital in both groups received systemic therapeutic hypothermia at 32°C to 34°C for 24 hours. Main Outcomes and Measures: The primary outcome was survival with good neurologic outcome, defined as Cerebral Performance Category (CPC) 1-2, at 90 days. Secondary outcomes were survival at 90 days and time to reach core body temperature less than 34°C. Results: Among the 677 randomized patients (median age, 65 years; 172 [25%] women), 671 completed the trial. Median time to core temperature less than 34°C was 105 minutes in the intervention group vs 182 minutes in the control group (P < .001). The number of patients with CPC 1-2 at 90 days was 56 of 337 (16.6%) in the intervention cooling group vs 45 of 334 (13.5%) in the control group (difference, 3.1% [95% CI, -2.3% to 8.5%]; relative risk [RR], 1.23 [95% CI, 0.86-1.72]; P = .25). In the intervention group, 60 of 337 patients (17.8%) were alive at 90 days vs 52 of 334 (15.6%) in the control group (difference, 2.2% [95% CI, -3.4% to 7.9%]; RR, 1.14 [95% CI, 0.81-1.57]; P = .44). Minor nosebleed was the most common device-related adverse event, reported in 45 of 337 patients (13%) in the intervention group. The adverse event rate within 7 days was similar between groups. Conclusions and Relevance: Among patients with out-of-hospital cardiac arrest, trans-nasal evaporative intra-arrest cooling compared with usual care did not result in a statistically significant improvement in survival with good neurologic outcome at 90 days. Trial Registration: ClinicalTrials.gov Identifier: NCT01400373.Peer reviewedFinal Accepted Versio

Why Treat Apogeotropic BPPVs of the Horizontal Canal? About 30 Observations

Benign paroxysmal positional vertigo (BPPV), of the horizontal canal, in the apogeotropic form (AHBPPV) was described in 1995. Based on 30 observations of typical AHBPPVs of the horizontal canal, we endeavor to discuss the relevance of physiotherapy. Material and Method. Thirty observations of typical apogeotropic BPPVs of the horizontal canal treated with a 360° barbeque rotation on the BPPV side, reviewed in consultation at 1 and 3 weeks and reevaluated the following year. Results. Our cohort of 30 patients had an average age of 58.6 years. The apogeotropic BPPVs of the horizontal canal, which can be transformed into BPPVs of the posterior canal or into geotropic-type BPPVs of the horizontal canal do not recover more quickly. Patients who follow the positional advice do not recover more quickly than those who do not (P = 0.152). The 15 patients treated on average 13.73 days after the onset of the disease did not recover more quickly after the start of therapeutic treatment than those treated later (P = 0.032). Conclusion. Here, we demonstrate that the direction of rotation during the maneuvers is of no importance for the results. We show that transformability is not a guarantee of rapid recovery and that the therapist's effectiveness is limited when it comes to the short-term results

Facteurs associés à la survie des patients présentant une hypothermie sévère

Dans cette étude rétrospective sur 10 ans, nous avons évalué l ensemble des patients présentant une hypothermie accidentelle sévère admis au déchoquage du centre de traumatologie de référence de l arc alpin. L objectif de l étude était de déterminer les facteurs associés à la survie des patients admis avec une température centrale inférieure à 28C. Les facteurs de mauvais pronostic que nous avons mis en évidence étaient un arrêt cardiaque survenu avant l arrivée des secours et par rapport au patient ayant survécu, un pH et un TP abaissé et une augmentation de la natrémie, de la kaliémie, des lactates, de la créatinémie et du TCA à l admission. Le rescue collapse , défini comme un arrêt cardiaque survenu pendant la prise en charge des secours notamment lors de la mobilisation, n est pas un facteur de pronostic péjoratif. La réanimation des patients présentant un rescue collapse devrait être poursuivie. L orientation devrait s effectuer vers un centre équipé d Extracorporeal Life Support (ECLS) de réchauffement même si le délai de transport est extrêmement long. A l inverse, la constatation d un arrêt cardiaque survenu avant l arrivée des secours est un élément péjoratif, même en hypothermie, et pourrait constituer un élément de décision pour la non mise sous ECLS. Cette étude met en évidence des facteurs pouvant aider les cliniciens dans leurs décisions pour prendre en charge des patients présentant une hypothermie sévère. Du fait de l effet protecteur de l hypothermie, il est important de noter que la survie dans des conditions exceptionnelles est parfois possible et peut dépendre de l orientation des patients vers un centre disposant d un plateau technique adapté.GRENOBLE1-BU Médecine pharm. (385162101) / SudocSudocFranceF

Évaluation de la gravité ressentie par les familles des patients pris en charge en intervention SMUR après information médicale

Objectif: Le but de notre travail est d évaluer pour des patients pris en charge en préhospitalier par un SMUR la compréhension de l information médicale par la famille en ce qui concerne la gravité de leur proche et de déterminer les facteurs qui l altèrent. Méthodes : Il s agit d une étude observationnelle prospective multicentrique réalisée dans 4 SMUR de Rhône-Alpes de juin à octobre 2012. Les données ont été recueillies à l aide de questionnaires immédiatement après l intervention. La Classification Clinique des Malades du SMUR (CCMS) et sa traduction validée compréhensible pour les proches ont été utilisées comme critère de jugement. Résultats : 184 proches et médecins ont complété le questionnaire. Leur anxiété (6 [Intervalle de Confiance (IC) 95% 5,6-6,5] en moyenne sur une échelle de 0 à 10) est sous-estimée par le médecin (4,2 [IC95% 3,8-4,5]). Nous retrouvons une faible corrélation entre la CCMS cotée par la famille et celle décrite par le médecin (kappa pondéré=0,32). Une analyse multivariée a permis d isoler trois facteurs d altération de la compréhension : l anxiété (odds ratio (OR) 1,35, IC95% [1,1-1,7], p=0,014), un faible niveau d éducation (OR 4,6, IC95% [1,3-16,3], p=0,018) et une gravité élevée de l état du patient (OR 2,35, IC95% [1,2-3,8], p=0,009). Conclusion: Nos données suggèrent que les médecins doivent s efforcer de rapidement identifier les situations à risque de faible compréhension à savoir : un proche anxieux, un proche témoignant d un faible niveau d éducation ou un patient grave. La traduction de la CCMS en langage compréhensible par les proches a été validée et pourrait désormais être un outil employé en intervention.Objective: The aim of our study was to evaluate patients, supported by Mobile Intensive Care Unit (MICU), and their families understanding of medical information regarding the severity of their loved ones state and to determine the factors that affect them most. Methods: We conducted a prospective, multicenter observational study in four MICU of the Rhône-Alpes region from June to October 2012. Data were collected using questionnaires immediately after the intervention. Clinical Classification of Patients of SMUR (CCMS) and its translation validated understandable for relatives were used as primary endpoint judgment criteria. Results: 184 relatives and physicians completed the questionnaire. Their anxiety (6 [95% confidence interval (CI) 5.6 to 6.5] on average on a scale of 0 to 10) is underestimated by the physician (4.2 [95% CI 3.8 to 4.5]). We found a weak correlation between CCMS listed by family and described by the doctor (weighted kappa = 0.32) and only 43% of family perceived severity accurately. Multivariate analysis was used to isolate three factors of impaired comprehension: anxiety (odds ratio (OR) 1.35, 95% CI [1.1-1.7], p = 0.014), low level of education (OR 4.6, 95% CI [1.3-16.3], p = 0.018) and a high severity of the patient's condition (OR 2.35, 95% CI [1.2-3.8], p = 0.009). Conclusion: Our data suggests that physicians should strive to quickly identify situations at risk of poor understanding namely an anxious relative, a relative indicating a low level of education or a critical patient. Translation of CCMS in language understandable by relatives has been validated and could now be used as a tool.GRENOBLE1-BU Médecine pharm. (385162101) / SudocSudocFranceF

Head and thorax elevation prevents the rise of intracranial pressure during extracorporeal resuscitation in swine

Aim: Head and thorax elevation during cardiopulmonary resuscitation improves cerebral hemodynamics and ultimate neurological outcome after cardiac arrest. Its effect during extracorporeal cardiopulmonary resuscitation (E-CPR) is unknown. We tested whether this procedure could improve hemodynamics in swine treated by E-CPR. Methods and Results: Pigs were anesthetized and submitted to 15 minutes of untreated ventricular fibrillation followed by E-CPR. Animals randomly remained in flat position (flat group) or underwent head and thorax elevation since E-CPR institution (head-up group). Electric shocks were delivered after 30 minutes until the return of spontaneous circulation (ROSC). They were followed during 120 minutes after ROSC. After 30 minutes of E-CPR, ROSC was achieved in all animals, with no difference regarding blood pressure, heart rate, and extracorporeal membrane of oxygenation flow among groups. The head-up group had an attenuated increase in ICP as compared with the flat group after cardiac arrest (13 ± 1 vs. 26 ± 2 mm Hg at the end of the follow-up, respectively). Cerebral perfusion pressure tended to be higher in the head-up versus flat group despite not achieving statistical difference (66 ± 1 vs 46 ± 1 mm Hg at the end of the follow-up). Carotid blood flow and cerebral oxygen saturation were not significantly different among groups. Conclusion: During E-CPR, head and thorax elevation prevents ICP increase. Whether it could improve the ultimate neurological outcome in this situation deserves further investigation.The study was supported by grants LIVE-RESP and AREG-SHOCK from Agence Nationale pour la Recherche. Y. Levy was supported by ADEREMVeterinari

Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study.

BACKGROUND: Intravenous morphine (IVM) is the most common strong analgesic used in trauma, but is associated with a clear time limitation related to the need to obtain an access route. The intranasal (IN) route provides easy administration with a fast peak action time due to high vascularization and the absence of first-pass metabolism. We aimed to determine whether IN sufentanil (INS) for patients presenting to an emergency department with acute severe traumatic pain results in a reduction in pain intensity non-inferior to IVM. METHODS AND FINDINGS: In a prospective, randomized, multicenter non-inferiority trial conducted in the emergency departments of 6 hospitals across France, patients were randomized 1:1 to INS titration (0.3 μg/kg and additional doses of 0.15 μg/kg at 10 minutes and 20 minutes if numerical pain rating scale [NRS] > 3) and intravenous placebo, or to IVM (0.1 mg/kg and additional doses of 0.05 mg/kg at 10 minutes and 20 minutes if NRS > 3) and IN placebo. Patients, clinical staff, and research staff were blinded to the treatment allocation. The primary endpoint was the total decrease on NRS at 30 minutes after first administration. The prespecified non-inferiority margin was -1.3 on the NRS. The primary outcome was analyzed per protocol. Adverse events were prospectively recorded during 4 hours. Among the 194 patients enrolled in the emergency department cohort between November 4, 2013, and April 10, 2016, 157 were randomized, and the protocol was correctly administered in 136 (69 IVM group, 67 INS group, per protocol population, 76% men, median age 40 [IQR 29 to 54] years). The mean difference between NRS at first administration and NRS at 30 minutes was -4.1 (97.5% CI -4.6 to -3.6) in the IVM group and -5.2 (97.5% CI -5.7 to -4.6) in the INS group. Non-inferiority was demonstrated (p < 0.001 with 1-sided mean-equivalence t test), as the lower 97.5% confidence interval of 0.29 (97.5% CI 0.29 to 1.93) was above the prespecified margin of -1.3. INS was superior to IVM (intention to treat analysis: p = 0.034), but without a clinically significant difference in mean NRS between groups. Six severe adverse events were observed in the INS group and 2 in the IVM group (number needed to harm: 17), including an apparent imbalance for hypoxemia (3 in the INS group versus 1 in the IVM group) and for bradypnea (2 in the INS group versus 0 in the IVM group). The main limitation of the study was that the choice of concomitant analgesics, when they were used, was left to the discretion of the physician in charge, and co-analgesia was more often used in the IVM group. Moreover, the size of the study did not allow us to conclude with certainty about the safety of INS in emergency settings. CONCLUSIONS: We confirm the non-inferiority of INS compared to IVM for pain reduction at 30 minutes after administration in patients with severe traumatic pain presenting to an emergency department. The IN route, with no need to obtain a venous route, may allow early and effective analgesia in emergency settings and in difficult situations. Confirmation of the safety profile of INS will require further larger studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT02095366. EudraCT 2013-001665-16

Quality of life perception of type 1 diabetic patients treated with insulin analogs and receiving medication review with follow-up in a public health care service from Ponta Grossa-PR, Brazil

ABSTRACT Glycemic control in patients with diabetes mellitus type 1 (DM1) reduces the risk of complications but requires a rigorous health care routine. Thus, diabetes education is central to increasing treatment compliance and self-care practices. This study aimed to evaluate the quality of life (QoL) and glycemic control of DM1 patients being treated with insulin analogs and receiving medication review with follow-up. This was a transversal study that included 110 patients registered at the 3rd Health Regional of Ponta Grossa-PR, aged &#8805; 18 years, and receiving pharmaceutical care for at least 1 year. The Diabetes Quality of Life Measure (DQOL)-Brazil was used to evaluate QoL. The data were statistically analyzed using SPSS version 17.0 with 95% confidence levels. Of the 110 patients, 58.2% were women. The average age was 33.7 years (±10.5), and the average glycated hemoglobin (HbA1c) value was 8% (±1.4). The mean total DQOL-Brazil score was 2.11 (95% confidence interval, 2.02 - 2.21). All DQOL-Brazil scores were lower in patients with HbA1c &#8804; 8%, indicating a better QoL. Good glycemic control, thus, appears to have a positive influence on the QoL, and pharmaceutical interventions are able to contribute to the achievement of therapeutic targets