Noninvasive Ventilation for Acute Respiratory Failure in Pediatric Patients: A Systematic Review and Meta-Analysis.

OBJECTIVE: To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) on the use of noninvasive ventilation (NIV) for acute respiratory failure (ARF) in pediatric patients. DATA SOURCES: We searched PubMed, EMBASE, the Cochrane Central Register of Clinical Trials, and Clinicaltrials.gov with a last update on July 31, 2022. STUDY SELECTION: We included RCTs comparing NIV with any comparator (standard oxygen therapy and high-flow nasal cannula [HFNC]) in pediatric patients with ARF. We excluded studies performed on neonates and on chronic respiratory failure patients. DATA EXTRACTION: Baseline characteristics, intubation rate, mortality, and hospital and ICU length of stays were extracted by trained investigators. DATA SYNTHESIS: We identified 15 RCTs (2,679 patients) for the final analyses. The intubation rate was 109 of 945 (11.5%) in the NIV group, and 158 of 1,086 (14.5%) in the control group (risk ratio, 0.791; 95% CI, 0.629-0.996; p = 0.046; I2 = 0%; number needed to treat = 31). Findings were strengthened after removing studies with intervention duration shorter than an hour and after excluding studies with cross-over as rescue treatment. There was no difference in mortality, and ICU and hospital length of stays. CONCLUSIONS: In pediatric patients, NIV applied for ARF might reduce the intubation rate compared with standard oxygen therapy or HFNC. No difference in mortality was observed.

FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients.

Adverse drug reactions (ADRs) reduce patients' quality of life, increase mortality and morbidity, and have a negative economic impact on healthcare systems. Nevertheless, the importance of ADR reporting is often underestimated. The project "FarmaREL" has been developed to monitor and evaluate ADRs in haematological patients and to increase pharmacovigilance culture among haematology specialists. In 13 haematology units, based in Lombardy, Italy, a dedicated specialist with the task of encouraging ADRs reporting and sensitizing healthcare professionals to pharmacovigilance has been assigned. The ADRs occurring in haematological patients were collected electronically and then analysed with multiple logistic regression. Between January 2009 and December 2011, 887 reports were collected. The number of ADRs was higher in older adults (528; 59%), in male (490; 55%), and in non-Hodgkin lymphoma patients (343; 39%). Most reactions were severe (45% required or prolonged hospitalization), but in most cases, they were fully resolved at the time of reporting. According to Schumock and Thornton criteria, a percentage of ADRs as high as 7% was found to be preventable versus 2% according to reporter opinion. Patients' haematological diagnosis, not age or gender, resulted to be the variable that most influenced ADR, in particular severity and outcome. The employment of personnel specifically dedicated to pharmacovigilance is a successful strategy to improve the number and quality of ADR reports. "FarmaREL", the first programme of active pharmacovigilance in oncohaematologic patients, significantly contributed to reach the WHO "Gold Standard" for pharmacovigilance in Lombardy, Italy.

Towards a less invasive approach to the early goal-directed treatment of septic shock in the ED.

INTRODUCTION: Early goal-directed therapy (EGDT) in septic shock defined by Rivers et al was proven to reduce mortality and validated by observational studies. However, criticism is centered in particular on the early requirement of a central venous catheter (CVC) and on central venous pressure (CVP) as an indicator of volume responsiveness. The present study is a pivotal study to investigate the reliability of a less invasive approach, which uses inferior vena cava (IVC) and lung ultrasounds (US) to guide the infusion of fluids and lactate clearance to monitor tissue perfusion. METHODS: We enrolled 51 patients with septic shock. As a marker of preload optimization, we measured IVC collapse in place of CVP and serum lactate clearance in place of central venous oxygen saturation as a marker of tissue perfusion. As outcomes, we considered the accomplishment of the noninvasive EGDT goals, the number of patients treated without the need of a CVC, the amount of fluids administered in the first 6 hours, the development of pulmonary edema, and the overall mortality rate. RESULTS: Inferior vena cava US evaluation resulted feasible in 92% of patients. Lung US was performed in 100% of cases. In the first 6 hours, only 61.7% of patients received a CVC, an average of 5.5 L of crystalloids were administered, and only 4 patients developed clinical overt pulmonary edema. Mortality was 34% at 28 days and 38.3% at 60 days. CONCLUSIONS: Our approach to resuscitation in septic shock appears feasible in the emergency department and needs further study with a randomized controlled trial.