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Invasive mechanical ventilation in critically ill adults involves adjusting the fraction of inspired oxygen to maintain arterial oxygen saturation. The oxygen-saturation target that will optimize clinical outcomes in this patient population remains unknown. In a pragmatic, cluster-randomized, cluster-crossover trial conducted in the emergency department and medical intensive care unit at an academic center, we assigned adults who were receiving mechanical ventilation to a lower target for oxygen saturation as measured by pulse oximetry (Spo ) (90%; goal range, 88 to 92%), an intermediate target (94%; goal range, 92 to 96%), or a higher target (98%; goal range, 96 to 100%). The primary outcome was the number of days alive and free of mechanical ventilation (ventilator-free days) through day 28. The secondary outcome was death by day 28, with data censored at hospital discharge. A total of 2541 patients were included in the primary analysis. The median number of ventilator-free days was 20 (interquartile range, 0 to 25) in the lower-target group, 21 (interquartile range, 0 to 25) in the intermediate-target group, and 21 (interquartile range, 0 to 26) in the higher-target group (P = 0.81). In-hospital death by day 28 occurred in 281 of the 808 patients (34.8%) in the lower-target group, 292 of the 859 patients (34.0%) in the intermediate-target group, and 290 of the 874 patients (33.2%) in the higher-target group. The incidences of cardiac arrest, arrhythmia, myocardial infarction, stroke, and pneumothorax were similar in the three groups. Among critically ill adults receiving invasive mechanical ventilation, the number of ventilator-free days did not differ among groups in which a lower, intermediate, or higher Spo target was used. (Supported by the National Heart, Lung, and Blood Institute and others; PILOT ClinicalTrials.gov number, NCT03537937.).

Randomized trials evaluating emergency treatments may be conducted with Exception from Informed Consent (EFIC) when informed consent is infeasible. In EFIC trials, a period of community consultation and public disclosure precedes initiation of enrollment. The Randomized Trial of Sedative Choice for Intubation (RSI) was a 2,365-patient randomized trial conducted with EFIC in 14 emergency departments and intensive care units across the United States. This manuscript reports the approach to community consultation and public disclosure in the RSI trial. Community consultation and public disclosure were conducted locally in each region of enrolling sites. The coordinating center provided sites with templates and access to an engagement coordinator to assist with developing and executing site plans. Community consultation and public disclosure occurred at the coordinating center from February 2021-January 2022 and in the regions of the five additional enrolling sites from September 2023-June 2024. Community consultation included in-person surveys with 789 patients or family members in emergency department or intensive care unit waiting rooms and invitation of more than 200 local groups to town halls or Community Engagement Studios. Public disclosure included (i) social media advertisements viewed more than 1.2 million times, (ii) a trial website with more than 16,000 unique visitors, (iii) informational flyers in hospitals and public settings, and (iv) featured information in traditional media. Completing local community consultation and public disclosure required an average of 139 h of research personnel time and approximately $18,822 at each site, in addition to coordinating center effort and costs. Pre-trial community consultation activities in the RSI trial engaged over 1,000 patients, families, and community members and public disclosure reached over 1.2 million community members. While the total cost and duration of activities at sites were substantially lower than reported in prior EFIC trials, these costs remained significant. ClinicalTrials.gov; No.: NCT05277896; URL: www. gov.

IntroductionMechanical ventilation of intensive care unit (ICU) patients universally involves titration of the fraction of inspired oxygen to maintain arterial oxygen saturation (SpO2). However, the optimal SpO2 target remains unknown.Methods and analysisThe Pragmatic Investigation of optimaL Oxygen Targets (PILOT) trial is a prospective, unblinded, pragmatic, cluster-crossover trial being conducted in the emergency department (ED) and medical ICU at Vanderbilt University Medical Center in Nashville, Tennessee, USA. PILOT compares use of a lower SpO2 target (target 90% and goal range: 88%–92%), an intermediate SpO2 target (target 94% and goal range: 92%–96%) and a higher SpO2 target (target 98% and goal range: 96%–100%). The study units are assigned to a single SpO2 target (cluster-level allocation) for each 2-month study block, and the assigned SpO2 target switches every 2 months in a randomly generated sequence (cluster-level crossover). The primary outcome is ventilator-free days (VFDs) to study day 28, defined as the number of days alive and free of invasive mechanical ventilation from the final receipt of invasive mechanical ventilation through 28 days after enrolment.Ethics and disseminationThe trial was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.Trial registration numberThe trial protocol was registered with ClinicalTrials.gov on 25 May 2018 prior to initiation of patient enrolment (ClinicalTrials.gov identifier: NCT03537937).

Introduction Survivors of acute respiratory failure (ARF) commonly experience long-lasting physical, cognitive, and/or mental health impairments. Unmet medication needs occurring immediately after hospital discharge may have an important effect on subsequent recovery. Methods and analysis In this multicenter prospective cohort study, we enrolled ARF survivors who were discharged directly home from their acute care hospitalization. The primary exposure was unmet medication needs . The primary outcome was hospital readmission or death within 3 months after discharge. We performed a propensity score analysis, using inverse probability weighting for the primary exposure, to evaluate the exposure–outcome association, with an a priori sample size of 200 ARF survivors. Results We enrolled 200 ARF survivors, of whom 107 (53%) were female and 77 (39%) were people of color. Median (IQR) age was 55 (43–66) years, APACHE II score 20 (15–26) points, and hospital length of stay 14 (9–21) days. Of the 200 participants, 195 (98%) were in the analytic cohort. One hundred fourteen (57%) patients had at least one unmet medication need; the proportion of medication needs that were unmet was 6% (0–15%). Fifty-six (29%) patients were readmitted or died by 3 months; 10 (5%) died within 3 months. Unmet needs were not associated (risk ratio 1.25; 95% CI 0.75–2.1) with hospital readmission or death, although a higher proportion of unmet needs may have been associated with increased hospital readmission (risk ratio 1.7; 95% CI 0.96–3.1) and decreased mortality (risk ratio 0.13; 95% CI 0.02–0.99). Discussion Unmet medication needs are common among survivors of acute respiratory failure shortly after discharge home. The association of unmet medication needs with 3-month readmission and mortality is complex and requires additional investigation to inform clinical trials of interventions to reduce unmet medication needs. Study registration number : NCT03738774 . The study was prospectively registered before enrollment of the first patient.

Background: Hematopoietic stem cell transplantation (HSCT) is currently the only cure for sickle cell disease (SCD), but only a fraction of eligible children proceed to transplantation. We aimed to understand parental awareness and perceptions as a contributor. Purpose: To discuss HSCT with parents of children with SCD and assess their awareness and perceptions. Methods: A standardized educational session and pre-post surveys were used. Results: Fifty-seven parents completed the educational session. Parental awareness of HSCT and independent search for information were poor; only 40% of parents were previously aware of HSCT as a treatment option in SCD. However, 91% reported that the information was valuable, and 67% that they would consider HSCT as a treatment option for their child. Parents' main concerns were death, isolation, and infertility. Discussion: Our results support the use of structured educational materials during routine SCD health visits to provide information to parents about HSCT and begin discussing complex treatment options. Translation to Health Education Practice: Our results are relevant to clinicians, health educators, and patient advocates responsible for counseling parents of children with chronic conditions about high-risk curative options. A patient education sheet was generated from this experience and will be used to standardize ongoing parental education at our institutions.

Yet drinking enough fluids is often a neglected part of our diet, especially for children. Many people assume that they need to drink only when they are thirsty or drink just enough to quench thirst. We should pay attention to the benefits of drinking fluids and encourage children to do the same. The benefits of drinking enough fluids are that it prevents dehydration, maintains regular bowel habits and keeps skin and hair looking healthy. We obtain water from fluids such as water, milk, fruit juice, cordials, soft drinks and soups. Even foods such as rice, bread, noodles, fruit and vegetables have some water in them although not enough to meet our fluid needs. The amount of fluid children need depends on their age, weight and activity. The table below outlines the fluid needs of young children. As an example, a 16kg child would require 2,000ml (125ml x 16kg = 2,000ml) of water which is equivalent to eight glasses of fluids per day. This is a lot to drink each day. Many children balk at drinking plain water so offering a variety of fluids, such as milk, juice and even soups will help them achieve their daily fluid intake with greater ease and enjoyment.