Management of syncope in the Emergency Department: a European prospective cohort study (SEED).

BACKGROUND AND IMPORTANCE: In 2018, the European Society of Cardiology (ESC) produced syncope guidelines that for the first-time incorporated Emergency Department (ED) management. However, very little is known about the characteristics and management of this patient group across Europe. OBJECTIVES: To examine the prevalence, clinical presentation, assessment, investigation (ECG and laboratory testing), management and ESC and Canadian Syncope Risk Score (CSRS) categories of adult European ED patients presenting with transient loss of consciousness (TLOC, undifferentiated or suspected syncope). DESIGN: Prospective, multicentre, observational cohort study. SETTINGS AND PARTICIPANTS: Adults (≥18 years) presenting to European EDs with TLOC, either undifferentiated or thought to be of syncopal origin. MAIN RESULTS: Between 00:01 Monday, September 12th to 23:59 Sunday 25 September 2022, 952 patients presenting to 41 EDs in 14 European countries were enrolled from 98 301 ED presentations (n = 40 sites). Mean age (SD) was 60.7 (21.7) years and 487 participants were male (51.2%). In total, 379 (39.8%) were admitted to hospital and 573 (60.2%) were discharged. 271 (28.5%) were admitted to an observation unit first with 143 (52.8%) of these being admitted from this. 717 (75.3%) participants were high-risk according to ESC guidelines (and not suitable for discharge from ED) and 235 (24.7%) were low risk. Admission rate increased with increasing ESC high-risk factors; 1 ESC high-risk factor; n = 259 (27.2%, admission rate=34.7%), 2; 189 (19.9%; 38.6%), 3; 106 (11.1%, 54.7%, 4; 62 (6.5%, 60.4%), 5; 48 (5.0%, 67.9%, 6+; 53 (5.6%, 67.9%). Furthermore, 660 (69.3%), 250 (26.3%), 34 (3.5%) and 8 (0.8%) participants had a low, medium, high, and very high CSRS respectively with respective admission rates of 31.4%, 56.0%, 76.5% and 75.0%. Admission rates (19.3-88.9%), use of an observation/decision unit (0-100%), and percentage high-risk (64.8-88.9%) varies widely between countries. CONCLUSION: This European prospective cohort study reported a 1% prevalence of syncope in the ED. 4 in 10 patients are admitted to hospital although there is wide variation between country in syncope management. Three-quarters of patients have ESC high-risk characteristics with admission percentage rising with increasing ESC high-risk factors.

High-flow nasal oxygen versus conventional oxygen therapy in patients with COVID-19 pneumonia and mild hypoxaemia: a randomised controlled trial.

RATIONALE: In patients with COVID-19 pneumonia and mild hypoxaemia, the clinical benefit of high-flow nasal oxygen (HFNO) remains unclear. We aimed to examine whether HFNO compared with conventional oxygen therapy (COT) could prevent escalation of respiratory support in this patient population. METHODS: In this multicentre, randomised, parallel-group, open-label trial, patients with COVID-19 pneumonia and peripheral oxygen saturation (SpO2) ≤92% who required oxygen therapy were randomised to HFNO or COT. The primary outcome was the rate of escalation of respiratory support (ie, continuous positive airway pressure, non-invasive ventilation or invasive mechanical ventilation) within 28 days. Among secondary outcomes, clinical recovery was defined as the improvement in oxygenation (SpO2 ≥96% with fractional inspired oxygen (FiO2) ≤30% or partial pressure of arterial carbon dioxide/FiO2 ratio >300 mm Hg). RESULTS: Among 364 randomised patients, 55 (30.3%) of 181 patients assigned to HFNO and 70 (38.6%) of 181 patients assigned to COT underwent escalation of respiratory support, with no significant difference between groups (absolute risk difference -8.2% (95% CI -18% to +1.4%); RR 0.79 (95% CI 0.59 to 1.05); p=0.09). There was no significant difference in clinical recovery (69.1% vs 60.8%; absolute risk difference 8.2% (95% CI -1.5% to +18.0%), RR 1.14 (95% CI 0.98 to 1.32)), intensive care unit admission (7.7% vs 11.0%, absolute risk difference -3.3% (95% CI -9.3% to +2.6%)), and in hospital length of stay (11 (IQR 8-17) vs 11 (IQR 7-20) days, absolute risk difference -1.0% (95% CI -3.1% to +1.1%)). CONCLUSIONS: Among patients with COVID-19 pneumonia and mild hypoxaemia, the use of HFNO did not significantly reduce the likelihood of escalation of respiratory support. TRIAL REGISTRATION NUMBER: NCT04655638.

The PaCO2/FiO2 ratio as outcome predictor in SARS-COV-2 related pneumonia: a retrospective study.

BACKGROUND AND AIM: Respiratory failure in SARS-CoV-2 patients is characterized by the presence of hypoxemia and hypocapnia without relevant dyspnea. To date, the use of respiratory parameters other than PaO2/FiO2 ratio to stratify the risk of worsening of these patients has not been sufficiently studied.  Aim of this work was to evaluate whether the ratio between partial pressure levels of carbon dioxide (PaCO2) and the fraction of inspired oxygen (FiO2) measured at emergency department (ED) admission is predictive of the clinical course of patients suffering from SARS-CoV-2 pneumonia. METHODS: We retrospectively studied 236 patients with SARS-CoV-2 pneumonia evaluated at the ED of the Perugia Hospital. The end-points were: in-hospital mortality, need for invasive mechanical ventilation (IMV) and length of in-hospital stay (LOS). Clinical, blood gas and laboratory data were collected at ED admission. RESULTS: Of the 236 patients 157 were male, the mean age was 64 ± 16. Thirtythree patients (14%) needed IMV, 49 died (21%). In the univariate analysis, the PaCO2/FiO2 ratio was inversely associated with the need for IMV (p <0.001), mortality (p <0.001) and LOS (p = 0.005). At the multivariate analysis the PaCO2/FiO2 ratio was found to be predictive of the need for IMV, independently from age, gender, number of comorbidities, neutrophils, lymphocytes, glomerular filtrate, d-dimer, LDH and CRP. CONCLUSIONS: the PaCO2/FiO2 ratio is predictive of the risk of respiratory failure worsening in patients with SARS-CoV-2 pneumonia, independently from other several confounding factors.

Patients who leave the Emergency Department without being seen. Has COVID-19 affected this phenomenon?

BACKGROUND AND AIM: Patients who present to an Emergency Department (ED) and leave without being seen by a physician represent a safety concern because they may become severely ill and experience adverse events as a result of lacking or delayed ED treatment. Prior to the COVID-19 outbreak, the increasing number of patients accessing care through the ED in Italy and throughout the world has had implications for health policies. METHODS: A retrospective cohort study that included all ED visits from 1st January 2013 to 31st December 2018 in the Perugia University Hospital has been carried out. RESULTS: During the 5 years investigated 26,344 out of 300,372 (8.77%) patients who attended the ED left the triage area before being seen with an average of 439 patients per month. The same phenomenon has been analysed from February to October 2020. During these 9 months there were a total of 1,824 out of 30,990 (5.88%) patients who left the ED without being seen with an average of 202 per month. The latter value is one third lower than the one related to the period investigated prior to the COVID-19 outbreak. CONCLUSIONS: Such investigation could help to differentiate actual essential demand from non-essential demand within the ED, which could inform quality-improvement policies. Several strategies could be implemented to lower the proportion of patients who leave the department without being seen. Reorganising the activities in the ED with different paths should be implemented with the aim of reducing waiting times and in turn patients' satisfaction.

SIMEU position paper on non-invasive respiratory support in COVID-19 pneumonia.

The rapid worldwide spread of the Coronavirus disease (COVID-19) crisis has put health systems under pressure to a level never experienced before, putting intensive care units in a position to fail to meet an exponentially growing demand. The main clinical feature of the disease is a progressive arterial hypoxemia which rapidly leads to ARDS which makes the use of intensive care and mechanical ventilation almost inevitable. The difficulty of health systems to guarantee a corresponding supply of resources in intensive care, together with the uncertain results reported in the literature with respect to patients who undergo early conventional ventilation, make the search for alternative methods of oxygenation and ventilation and potentially preventive of the need for tracheal intubation, such as non-invasive respiratory support techniques particularly valuable. In this context, the Emergency Department, located between the area outside the hospital and hospital ward and ICU, assumes the role of a crucial junction, due to the possibility of applying these techniques at a sufficiently early stage and being able to rapidly evaluate their effectiveness. This position paper describes the indications for the use of non-invasive respiratory support techniques in respiratory failure secondary to COVID-19-related pneumonia, formulated by the Non-invasive Ventilation Faculty of the Italian Society of Emergency Medicine (SIMEU) on the base of what is available in the literature and on the authors' direct experience. Rationale, literature, tips & tricks, resources, risks and expected results, and patient interaction will be discussed for each one of the escalating non-invasive respiratory techniques: standard oxygen, HFNCO, CPAP, NIPPV, and awake self-repositioning. The final chapter describes our suggested approach to the failing patient.

Examination of the relationship between emergency department presentations and population mortality: a multicenter analysis of emergency department presentations during the COVID-19 pandemic.

BACKGROUND: In the spring of 2020, Italy experienced a significant reduction in the number of emergency department (ED) presentations during the first wave of the COVID-19 pandemic. If ED access has an impact on patients' prognosis, such a reduction in ED presentations would be expected to correlate with a parallel increase in the mortality rate of the corresponding population. The aim of the present study was to evaluate the impact of reduced ED presentations on the all-cause mortality of the general population. METHODS: Absolute and relative variation in ED accesses from March 1 to April 30 of both 2019 and 2020 in three hub hospitals in areas with different COVID-19 prevalence and age-standardized mortality data from January 1 to June 30 in 2019 and 2020 of the same areas were evaluated. RESULTS: During March and April 2020, ED consults were decreased of approximately 50% in all three hospitals, as compared with the same months in 2019. There was a marked increase in cumulative mortality in Milan (high SARS-CoV2 infection spread zone) compared with the same period in 2019. In the other two municipalities (Ferrara and Perugia), which had intermediate and low levels of infection spread, the mortality in 2020 was not substantially changed from that of 2019. CONCLUSIONS: Taking into account the increase in mortality due to SARS-CoV-2, reductions in ED access did not seem to affect death rates. If this finding will be confirmed, ED organization and access would need to be reconsidered.

Non-invasive respiratory support in the treatment of acute hypoxemic respiratory failure secondary to CoViD-19 related pneumonia.

In the last 11 months, the SARS-CoV-2 pandemic has overwhelmed and disrupted the whole world in health, social and economic terms. We are progressively learning more and more about the epidemiological and clinical features that distinguish CoViD-19 from any previous experience in the emergency and critical care setting. Experiences are multiplying with regard to the use of non-invasive respiratory support techniques in the context of acute hypoxemic respiratory failure secondary to CoViD-19-related pneumonia. Doubts still far outweigh certainties, but a growing series of mostly monocentric and retrospective studies are becoming available as concrete decision-making and operational support for healthcare workers. In this review the available studies and experiences about non-invasive respiratory support in the treatment of Covid-19 related respiratory failure, mainly coming from outside the ICU setting, will be discussed.

High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial.

BACKGROUND: The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. METHODS: We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25-7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes. RESULTS: Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were - 6.8 mmHg (± 8.7) in the HFNT and - 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis. CONCLUSIONS: HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD. TRIAL REGISTRATION: The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).

Diagnosis and Treatment of Deep Vein Thrombosis in the Emergency Department: Results of an Italian Nominal Group Technique Study.

Early diagnosis and treatment of deep vein thrombosis (DVT) is a main issue in the Emergency setting. With the aim of assisting clinicians in the diagnosis and the subsequent management of DVT in the Emergency Departments, a Nominal Group Technique (NGT) study was conducted. A panel of 5 Italian experts developed 21 consensus statements based on available evidence and their clinical experience. The agreed consensus statements may assist clinicians in applying the results of clinical studies and clinical experience to routine care settings, providing guidance on all aspects of the risk assessment, prophylaxis, early diagnosis and appropriate treatment of DVT in the EDs.

High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial.

BACKGROUND: Noninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO2) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis. METHODS: We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial pH between 7.25 and 7.35 and PaCO2 ≥ 55 mmHg. Patients will be randomly assigned 1:1 to receive NIV or HFNT. NIV will be applied through a mask with a dedicated ventilator in pressure support mode. Positive end-expiratory pressure will be set at 3-5 cmH2O with inspiratory support to obtain a tidal volume between 6 and 8 ml/kg of ideal body weight. HFNT will be initially set at a temperature of 37 °C and a flow of 60 L/min. At 2 and 6 h we will assess arterial blood gases, vital parameters, respiratory rate, treatment intolerance and failure, need for endotracheal intubation, time spent under mechanical ventilation (both invasive and NIV), intensive care unit and hospital length of stay, and hospital mortality. Based on an α error of 5% and a ß error of 80%, with a standard deviation for PaCO2 equal to 15 mmHg and a noninferiority limit of 10 mmHg, we computed a sample size of 56 patients. Considering potential drop-outs and nonparametric analysis, the final computed sample size was 80 patients (40 per group). DISCUSSION: HFNT is more comfortable than NIV in COPD patients recovering from an episode of exacerbation. If HFNT would not be inferior to NIV, HFNT could be considered as an alternative to NIV to treat COPD patients with mild-to-moderate respiratory acidosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03370666 . Registered on December 12, 2017.

High-flow nasal cannula oxygenation utilization in respiratory failure.

High flow nasal cannula (HFNC) represents a new oxygenation system to be used in the treatment of respiratory emergencies. During HFNC therapy, the active humidification and air heating system allow the patient to tolerate higher flows by favouring physiologic mucociliary clearance and improving fluidity of respiratory secretions. Following this, FiO2 values are more stable and reliable, by reducing losses and minimizing ambient air entrainment. Several clinical trials in acute respiratory failure patients have suggested lower rate of invasive mechanical ventilation, improved comfort and enhanced survival by early HFNC utilization in comparison with conventional oxygen therapy (COT) or non-invasive ventilation (NIV). This review aims to summarize the main evidences on the use of HFNC in the acute setting and its major indications.

Non-invasive positive pressure ventilation in pneumonia outside Intensive Care Unit: An Italian multicenter observational study.

BACKGROUND AND OBJECTIVE: Non-Invasive Ventilation (NIV) represents a standard of care to treat some acute respiratory failure (ARF). Data on its use in pneumonia are lacking, especially in a setting outside the Intensive Care Unit (ICU). The aims of this study were to evaluate the use of NIV in ARF due to pneumonia outside the ICU, and to identify risk factors for in-hospital mortality. METHODS: Prospective, observational study performed in 19 centers in Italy. Patients with ARF due to pneumonia treated outside the ICU with either continuous positive airway pressure (CPAP) or noninvasive positive pressure ventilation (NPPV) were enrolled over a period of at least 3 consecutive months in 2013. Independent factors related to in-hospital mortality were evaluated. RESULTS: Among the 347 patients enrolled, CPAP was applied as first treatment in 176 (50.7%) patients,NPPV in 171 (49.3%). The NPPV compared with CPAP group showed a significant higher PaCO2 (55 [47-78] vs 37 [32-43] mmHg, p < 0.001), a lower arterial pH (7.30 [7.21-7.37] vs 7.43 [7.35-7.47], p < 0.001), higher HCO3- (28 [24-33] vs 24 [21-27] mmol/L, p < 0.001). De-novo ARF was more prevalent in CPAP group than in NPPV group (86/176 vs 31/171 patients,p < 0.001). In-hospital mortality was 23% (83/347). Do Not Intubate (DNI) order and Charlson Comorbidity Index (CCI) ≥3 were independent risk factors for in-hospital mortality. CONCLUSIONS: Outside ICU setting, CPAP was used mainly for hypoxemic non-hypercapnic ARF, NPPV for hypercapnic ARF. In-hospital mortality was mainly associated to patients' basal status (DNI status, CCI) rather than the baseline degree of ARF.

ANMCO-SIMEU Consensus Document: in-hospital management of patients presenting with chest pain.

Chest pain is a common general practice presentation that requires careful diagnostic assessment because of its diverse and potentially serious causes. However, the evaluation of acute chest pain remains challenging, despite many new insights over the past two decades. The percentage of patients presenting to the emergency departments because of acute chest pain appears to be increasing. Nowadays, there are two essential chest pain-related issues: (i) the missed diagnoses of acute coronary syndromes with a poor short-term prognosis; and (ii) the increasing percentage of hospitalizations of low-risk cases. It is well known that hospitalization of a low-risk chest pain patient can lead to unnecessary tests and procedures, with an increasing trend of complications and burden of costs. Therefore, the significantly reduced financial resources of healthcare systems induce physicians and administrators to improve the efficiency of care protocols for patients with acute chest pain. Despite the efforts of the Scientific Societies in producing statements on this topic, in Italy there is still a significant difference between emergency physicians and cardiologists in managing patients with chest pain. For this reason, the aim of the present consensus document is double: first, to review the evidence-based efficacy and utility of various diagnostic tools, and, second, to delineate the critical pathways (describing key steps) that need to be implemented in order to standardize the management of chest pain patients, making a correct diagnosis and treatment as uniform as possible across the entire country.

[ANMCO/SIMEU Consensus document: In-hospital management of patients presenting with chest pain]. / Documento di consenso ANMCO/SIMEU: Gestione intraospedaliera dei pazienti che si presentano con dolore toracico.

Chest pain is a common general practice presentation that requires careful diagnostic assessment because of its diverse and potentially serious causes. However, the evaluation of acute chest pain remains challenging, despite many new insights over the past two decades. The percentage of patients presenting to the emergency departments because of acute chest pain appears to be increasing. Nowadays, there are two essential chest pain-related issues: 1) the missed diagnoses of acute coronary syndromes with a poor short-term prognosis; 2) the increasing percentage of hospitalizations of low-risk cases.It is well known that hospitalization of a low-risk chest pain patient can lead to unnecessary tests and procedures, with an increasing trend of complications and burden of costs. Therefore, the significantly reduced financial resources of healthcare systems induce physicians and administrators to improve the efficiency of care protocols for patients with acute chest pain. Despite the efforts of the Scientific Societies in producing statements on this topic, in Italy there is still a significant difference between emergency physicians and cardiologists in managing patients with chest pain. For this reason, the aim of the present consensus document is double: first, to review the evidence-based efficacy and utility of various diagnostic tools, and, second, to delineate the critical pathways (describing key steps) that need to be implemented in order to standardize the management of chest pain patients, making a correct diagnosis and treatment as uniform as possible across the entire country.

Palliative use of non-invasive ventilation in end-of-life patients with solid tumours: a randomised feasibility trial.

BACKGROUND: Despite best-possible medical management, many patients with end-stage cancer experience breathlessness, especially towards the end of their lives. We assessed the acceptability and effectiveness of non-invasive mechanical ventilation (NIV) versus oxygen therapy in decreasing dyspnoea and the amount of opiates needed. METHODS: In this randomised feasibility study, we recruited patients from seven centres in Italy, Spain, and Taiwan, who had solid tumours and acute respiratory failure and had a life expectancy of less than 6 months. We randomly allocated patients to receive either NIV (using the Pressure Support mode and scheduled on patients' request and mask comfort) or oxygen therapy (using a Venturi or a reservoir mask). We used a computer-generated sequence for randomisation, stratified on the basis of patients' hypercapnic status (PaCO2 >45 mm Hg or PaCO2 ≤45 mm Hg), and assigned treatment allocation using opaque, sealed envelopes. Patients in both groups were given sufficient subcutaneous morphine to reduce their dyspnoea score by at least one point on the Borg scale. Our primary endpoints were to assess the acceptability of NIV used solely as a palliative measure and to assess its effectiveness in reducing dyspnoea and the amount of opiates needed compared with oxygen therapy. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00533143. FINDINGS: We recruited patients between Jan 15, 2008, and March 9, 2011. Of 234 patients eligible for recruitment, we randomly allocated 200 (85%) to treatment: 99 to NIV and 101 to oxygen. 11 (11%) patients in the NIV group discontinued treatment; no patients in the oxygen group discontinued treatment. Dyspnoea decreased more rapidly in the NIV group compared with the oxygen group (average change in Borg scale -0·58, 95% CI -0·92 to -0·23, p=0·0012), with most benefit seen after the first hour of treatment and in hypercapnic patients. The total dose of morphine during the first 48 h was lower in the NIV group than it was in the oxygen group (26·9 mg [37·3] for NIV vs 59·4 mg [SD 67·1] for oxygen; mean difference -32·4 mg, 95% CI -47·5 to -17·4). Adverse events leading to NIV discontinuation were mainly related to mask intolerance and anxiety. Morphine was suspended because of severe vomiting and nausea (one patient in each group), sudden respiratory arrest (one patient in the NIV group), and myocardial infarction (one patient in the oxygen group). INTERPRETATION: Our findings suggest that NIV is more effective compared with oxygen in reducing dyspnoea and decreasing the doses of morphine needed in patients with end-stage cancer. Further studies are needed to confirm our findings and to assess the effectiveness of NIV on other outcomes such as survival. The use of NIV is, however, restricted to centres with NIV equipment, our findings are not generalisable to all cancer or palliative care units. FUNDING: None.

Continuous positive airway pressure vs. pressure support ventilation in acute cardiogenic pulmonary edema: a randomized trial.

BACKGROUND: Both non-invasive continuous positive airway pressure (nCPAP) and non-invasive pressure support ventilation (nPSV) have been shown to be effective treatment for acute cardiogenic pulmonary edema (ACPE). In patients with severe ACPE who are treated with standard medical treatment, the baseline intubation rate is approximately 24%. STUDY OBJECTIVE: This study was conducted to compare the endotracheal intubation (ETI) rate using two techniques, nCPAP vs. nPSV. In addition, mortality rate, improvement in gas exchange, duration of ventilation, and hospital length of stay were also assessed. METHODS: This prospective, multi-center, randomized study enrolled 80 patients with ACPE who were randomized to receive nCPAP or nPSV (40 patients in each group) via an oronasal mask. Inclusion criteria were severe dyspnea, respiratory rate > 30 breaths/min, use of respiratory accessory muscles, or PaO(2)/FiO(2) < 200. RESULTS: ETI was required in 0 (0%) and in 3 (7.5%) patients in the nCPAP group and in the nPSV group, respectively (p = 0.241). No significant difference was observed in in-hospital mortality: 2 (5%) vs. 7 (17.5%) in nCPAP and nPSV groups, respectively (p = 0.154). No difference in hospital length of stay was observed between the two groups, nor was there a difference observed in duration of ventilation, despite a trend for reduced time with nPSV vs. nCPAP (5.91 ± 4.01 vs. 8.46 ± 7.14 h, respectively, p = 0.052). Both nCPAP and nPSV were effective in improving gas exchange, including in the subgroup of hypercapnic patients. CONCLUSIONS: Both methods are effective treatment for patients with ACPE. Non-invasive CPAP should be considered as the first line of treatment because it is easier to use and less expensive than non-invasive PSV.

Noninvasive ventilation in cardiogenic pulmonary edema: a multicenter randomized trial.

Studies employing noninvasive pressure support ventilation in cardiogenic pulmonary edema have been performed in the intensive care unit when overt respiratory failure is already present and in small groups of patients. In this multicenter study, performed in emergency departments, 130 patients with acute respiratory failure were randomized to receive medical therapy plus O2 (65 patients) or noninvasive pressure support ventilation (65 patients). The primary end point was the need for intubation; secondary end points were in-hospital mortality and changes in some physiological variables. Noninvasive pressure support ventilation improved PaO2/FIO2, respiratory rate, and dyspnea significantly faster. Intubation rate, hospital mortality, and duration of hospital stay were similar in the two groups. In the subgroup of hypercapnic patients noninvasive pressure support ventilation improved PaCO2 significantly faster and reduced the intubation rate compared with medical therapy (2 of 33 versus 9 of 31; p=0.015). Adverse events, including myocardial infarction, were evenly distributed in the two groups. We conclude that during acute respiratory failure due to cardiogenic pulmonary edema the early use of noninvasive pressure support ventilation accelerates the improvement in PaO2/FIO2, PaCO2, dyspnea, and respiratory rate, but does not affect the overall clinical outcome. Noninvasive pressure support ventilation does, however, reduce the intubation rate in the subgroup of hypercapnic patients.