BACKGROUND: The dynamic arterial elastance (EaDyn), calculated as pulse pressure variation divided by stroke volume variation, has been studied as a predictor of vasopressor weaning. However, its potential as a haemodynamic tool for tapering off vasopressors in patients with sepsis remains unexplored. Therefore, our study aimed to assess whether using EaDyn for weaning vasopressor support could reduce the duration of vasopressor support in patients with sepsis.
METHODS: This pragmatic single-centre controlled clinical trial will take place at Fundación Santa Fe de Bogotá, Colombia. Adult patients diagnosed with septic shock according to the sepsis-3 criteria and a Sequential Organ Failure Assessment score ≥4 will be included. A total of 114 patients (57 per group) will undergo conventional critical care monitoring, and the weaning of vasopressor support will be initiated based on the EaDyn or mean arterial pressure (MAP), depending on the assigned group. EaDyn will be estimated based on the measurements obtained from a PiCCO device connected to a PulsioFlex Monitoring Platform (PULSION Medical Systems SE, Feldkirchen, Germany). Our primary outcome is the difference in vasopressor support duration between the EaDyn and MAP groups.Participants and statisticians performing the statistical analysis will be blinded to the group allocation. Dependent and independent variables will be analysed through univariate and multivariate statistical tests. Since we will perform three repeated measurements for analysis, we will implement a Bonferroni post hoc correction. Additionally, Cox regression and Kaplan-Meier analyses will be conducted to address objectives related to time.
BACKGROUND: This study was approved by the Ethics Committee at Fundación Santa Fe de Bogotá (CCEI-16026-2024). Written informed consent will be obtained from all participants. The results will be disseminated through publication in peer-reviewed journals and presentations at national and international events.
BACKGROUND: NCT06118775.

BACKGROUND: Although pressure support ventilation is one of the most commonly used assisted ventilation modes in intensive care units, there is still a lack of precise strategies for setting pressure support. By performing an end-inspiratory airway occlusion, the difference between the peak and plateau airway pressure, which is defined as pressure muscle index (PMI), can be easily measured on the ventilator screen. Previous studies have shown that PMI is accurate in detecting high and low inspiratory effort. No study has been conducted to investigate the use of PMI as an indicator for setting inspiratory pressure support.
METHODS: This is a study protocol for a prospective, single-centre, randomised controlled, pilot trial. Sixty participants undergoing pressure support ventilation will be randomly assigned in a 1:1 ratio to the control group or intervention group, with pressure support adjusted according to standard care or guided by the PMI strategy for 48 hours, respectively. The feasibility of the PMI-guided strategy will be evaluated. The primary endpoint is the proportion of inspiratory effort measurements within a well-accepted \'normal\' range, which is predefined as oesophageal pressure-time product per minute between 50 and 200 cmH2O⋅s/min, for each patient during 48 hours of pressure support adjustment.
BACKGROUND: The study protocol has been approved by Beijing Tiantan Hospital (KY2023-005-02). The data generated in the present study will be available from the corresponding author on reasonable request. The results of the trial will be submitted to international peer-reviewed journals.
BACKGROUND: NCT05963737; ClinicalTrials.org.

OBJECTIVE: The objective was to analyse the associations of intensive care unit (ICU) and high care unit (HCU) organisational structure on in-hospital mortality among patients with sepsis in Japan\'s acute care hospitals.
METHODS: Multicentre cross-sectional study.
METHODS: Patients with sepsis aged ≥18 years who received critical care in acute care hospitals throughout Japan between April 2018 and March 2019 were identified using the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB).
METHODS: None.
METHODS: 10 968 patients with sepsis were identified. ICUs were categorised into three groups: type 1 ICUs (fulfilling stringent staffing criteria such as experienced intensivists and high nurse-to-patient ratios), type 2 ICUs (less stringent criteria) and HCUs (least stringent criteria).
METHODS: The study\'s primary outcome measure was in-hospital mortality. Cox proportional hazards regression analysis was performed to examine the impact of ICU/HCU groups on in-hospital mortality.
RESULTS: We analysed 2411 patients (178 hospitals) in the type 1 ICU group, 3653 patients (422 hospitals) in the type 2 ICU group and 4904 patients (521 hospitals) in the HCU group. When compared with the type 1 ICU group, the adjusted HRs for in-hospital mortality were 1.12 (95% CI 1.04 to 1.21) for the type 2 ICU group and 1.17 (95% CI 1.08 to 1.26) for the HCU group.
CONCLUSIONS: ICUs that fulfil more stringent staffing criteria were associated with lower in-hospital mortality among patients with sepsis than HCUs. Differences in organisational structure may have an association with outcomes in patients with sepsis, and this was observed by the NDB.

BACKGROUND: Tracheostomy is a common emergency procedure for critically ill patients to secure their airway. The speaking valve is a one-way ventilation valve that is attached to the end of the tracheostomy tube to help the patient remodel subglottic pressure. However, the efficacy and safety of speaking valves in adult patients with tracheostomy remain controversial. The purpose of this protocol is to describe and evaluate the effectiveness, safety and impact on the quality of life of speaking valves in adult patients with tracheostomy.
METHODS: We will search four English databases (PubMed, Embase, Cochrane Library and Web of Science), grey literature websites and reference lists of original studies to screen for studies that might meet the criteria. The two authors will independently screen the literature, extract data and assess the quality and risk of bias of the included studies. The primary outcomes will focus on the patients\' swallowing function, vocalisation and quality of life. We will use a fixed effects model or a random effects model based on heterogeneity testing or a descriptive analysis only. The quality of evidence on the effects of interventions will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation.
BACKGROUND: This study is based on the literature in the database and does not require the approval of the ethics committee. The results will be disseminated through a peer-reviewed journal and conferences.
UNASSIGNED: CRD42024502906.

OBJECTIVE: The utilisation of pH level measurements from gastric contents may indicate the preferred tip position of a nasogastric tube or monitor the efficacy of stress ulcer prophylaxis in critically ill patients. We aimed to determine the accuracy of pH strip (pHS) tests and pH liquid (pHL) tests compared with the standard pH meter (pHM).
METHODS: Diagnostic accuracy study.
METHODS: Gastric contents from medically critically ill patients.
METHODS: In total, 113 gastric samples were collected from 27 critically ill patients.
METHODS: The level of pH measured by pHM, pHS and pHL.
RESULTS: The pH values measured by pHM, pHS and pHL were 5.83 (IQR 5.12-6.61), 5.50 (IQR 5.00-6.00) and 5.75 (IQR 5.25-6.25), respectively. The pHS test showed greater accuracy, exhibiting a more positive correlation with the standard pHM measurement than the pHL test, with Y=0.95*X+0.56; rho=0.91, p<0.001, and Y=1.09*X - 0.72; rho=0.75, p<0.001, respectively. However, the pHS test demonstrated less agreement with the pHM than the pHL test, with biases of -0.27 versus 0.18, respectively. Noticeably, a slight variation in pHL from the standard pH values was found when we measured gastric contents with a pH lower than 5.
CONCLUSIONS: Both the pHS and pHL methods were good options for measuring gastric pH in critically ill patients. However, it was advisable to find alternative approaches to the pHL testing method when anticipated gastric acidity levels fall below 5.
BACKGROUND: TCTR20220530004.

BACKGROUND: Therapeutic interventions for disorders of consciousness lack consistency; evidence supports non-invasive brain stimulation, but few studies assess neuromodulation in acute-to-subacute brain-injured patients. This study aims to validate the feasibility and assess the effect of a multi-session transcranial alternating current stimulation (tACS) intervention in subacute brain-injured patients on recovery of consciousness, related brain oscillations and brain network dynamics.
METHODS: The study is comprised of two phases: a validation phase (n=12) and a randomised controlled trial (n=138). Both phases will be conducted in medically stable brain-injured adult patients (traumatic brain injury and hypoxic-ischaemic encephalopathy), with a Glasgow Coma Scale score ≤12 after continuous sedation withdrawal. Recruitment will occur at the intensive care unit of a Level 1 Trauma Centre in Montreal, Quebec, Canada. The intervention includes a 20 min 10 Hz tACS at 1 mA intensity or a sham session over parieto-occipital cortical sites, repeated over five consecutive days. The current\'s frequency targets alpha brain oscillations (8-13 Hz), known to be associated with consciousness. Resting-state electroencephalogram (EEG) will be recorded four times daily for five consecutive days: pre and post-intervention, at 60 and 120 min post-tACS. Two additional recordings will be included: 24 hours and 1-week post-protocol. Multimodal measures (blood samples, pupillometry, behavioural consciousness assessments (Coma Recovery Scale-revised), actigraphy measures) will be acquired from baseline up to 1 week after the stimulation. EEG signal analysis will focus on the alpha bandwidth (8-13 Hz) using spectral and functional network analyses. Phone assessments at 3, 6 and 12 months post-tACS, will measure long-term functional recovery, quality of life and caregivers\' burden.
BACKGROUND: Ethical approval for this study has been granted by the Research Ethics Board of the CIUSSS du Nord-de-l\'Île-de-Montréal (Project ID 2021-2279). The findings of this two-phase study will be submitted for publication in a peer-reviewed academic journal and submitted for presentation at conferences. The trial\'s results will be published on a public trial registry database (ClinicalTrials.gov).
BACKGROUND: NCT05833568.

OBJECTIVE: In order to predict at hospital admission the prognosis of patients with serious and life-threatening COVID-19 pneumonia, we sought to understand the clinical characteristics of hospitalised patients at admission as the SARS-CoV-2 pandemic progressed, document their changing response to the virus and its variants over time, and identify factors most importantly associated with mortality after hospital admission.
METHODS: Observational study using a prospective hospital systemwide COVID-19 database.
METHODS: 15-hospital US health system.
METHODS: 26 872 patients admitted with COVID-19 to our Northeast Ohio and Florida hospitals from 1 March 2020 to 1 June 2022.
METHODS: 60-day mortality (highest risk period) after hospital admission analysed by random survival forests machine learning using demographics, medical history, and COVID-19 vaccination status, and viral variant, symptoms, and routine laboratory test results obtained at hospital admission.
RESULTS: Hospital mortality fell from 11% in March 2020 to 3.7% in March 2022, a 66% decrease (p<0.0001); 60-day mortality fell from 17% in May 2020 to 4.7% in May 2022, a 72% decrease (p<0.0001). Advanced age was the strongest predictor of 60-day mortality, followed by admission laboratory test results. Risk-adjusted 60-day mortality had all patients been admitted in March 2020 was 15% (CI 3.0% to 28%), and had they all been admitted in May 2022, 12% (CI 2.2% to 23%), a 20% decrease (p<0.0001). Dissociation between observed and predicted decrease in mortality was related to temporal change in admission patient profile, particularly in laboratory test results, but not vaccination status or viral variant.
CONCLUSIONS: Hospital mortality from COVID-19 decreased substantially as the pandemic evolved but persisted after hospital discharge, eclipsing hospital mortality by 50% or more. However, after accounting for the many, even subtle, changes across the pandemic in patients\' demographics, medical history and particularly admission laboratory results, a patient admitted early in the pandemic and predicted to be at high risk would remain at high risk of mortality if admitted tomorrow.

OBJECTIVE: The objective of the study was to assess the clinical predictive value of the dynamics of absolute lymphocyte count (ALC) for 90-day all-cause mortality in sepsis patients in intensive care unit (ICU).
METHODS: Retrospective cohort study using big data.
METHODS: This study was conducted using the Medical Information Mart for Intensive Care IV database V.2.0 database.
METHODS: The primary outcome was 90-day all-cause mortality.
METHODS: Patients were included if they were diagnosed with sepsis on the first day of ICU admission. Exclusion criteria were ICU stay under 24 hours; the absence of lymphocyte count on the first day; extremely high lymphocyte count (>10×109/L); history of haematolymphatic tumours, bone marrow or solid organ transplants; survival time under 72 hours and previous ICU admissions. The analysis ultimately included 17 329 sepsis patients.
RESULTS: The ALC in the non-survivors group was lower on days 1, 3, 5 and 7 after admission (p<0.001). The ALC on day 7 had the highest area under the curve (AUC) value for predicting 90-day mortality. The cut-off value of ALC on day 7 was 1.0×109/L. In the restricted cubic spline plot, after multivariate adjustments, patients with higher lymphocyte counts had a better prognosis. After correction, in the subgroups with Sequential Organ Failure Assessment score ≥6 or age ≥60 years, ALC on day 7 had the lowest HR value (0.79 and 0.81, respectively). On the training and testing set, adding the ALC on day 7 improved all prediction models\' AUC and average precision values.
CONCLUSIONS: Dynamic changes of ALC are closely associated with 90-day all-cause mortality in sepsis patients. Furthermore, the ALC on day 7 after admission is a better independent predictor of 90-day mortality in sepsis patients, especially in severely ill or young sepsis patients.

BACKGROUND: Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource constraints including limited access to invasive mechanical ventilation and/or highly skilled acute care workers. Continuous positive airway pressure (CPAP) and high-flow oxygen by nasal cannula (HFNC) may prove useful to reduce intubation, and therefore, improve survival outcomes among critically ill patients, particularly in resource-limited settings, but data in such settings are lacking. The aim of this study is to determine whether CPAP or HFNC as compared with standard oxygen therapy, could reduce mortality among adults presenting with AHRF in a resource-limited setting.
METHODS: This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.
BACKGROUND: The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.
BACKGROUND: NCT04693403.
METHODS: 8 September 2023; version 5.

BACKGROUND: Norepinephrine (NE) is the first-line recommended vasopressor for restoring mean arterial pressure (MAP) in vasoplegic syndrome (vs) following cardiac surgery with cardiopulmonary bypass. However, solely focusing on target MAP values can lead to acute hypotension episodes during NE weaning. The Hypotension Prediction Index (HPI) is a machine learning algorithm embedded in the Acumen IQ device, capable of detecting hypotensive episodes before their clinical manifestation. This study evaluates the clinical benefits of an NE weaning strategy guided by the HPI.
UNASSIGNED: The Norahpi trial is a prospective, open-label, single-centre study that randomises 142 patients. Inclusion criteria encompass adult patients scheduled for on-pump cardiac surgery with postsurgical NE administration for vs patient randomisation occurs once they achieve haemodynamic stability (MAP>65 mm Hg) for at least 4 hours on NE. Patients will be allocated to the intervention group (n=71) or the control group (n=71). In the intervention group, the NE weaning protocol is based on MAP>65 mmHg and HPI<80 and solely on MAP>65 mm Hg in the control group. Successful NE weaning is defined as achieving NE weaning within 72 hours of inclusion. An intention-to-treat analysis will be performed. The primary endpoint will compare the duration of NE administration between the two groups. The secondary endpoints will include the prevalence, frequency and time of arterial hypotensive events monitored by the Acumen IQ device. Additionally, we will assess cumulative diuresis, the total dose of NE, and the number of protocol weaning failures. We also aim to evaluate the occurrence of postoperative complications, the length of stay and all-cause mortality at 30 days.
BACKGROUND: Ethical approval has been secured from the Institutional Review Board (IRB) at the University Hospital of Amiens (IRB-ID:2023-A01058-37). The findings will be shared through peer-reviewed publications and presentations at national and international conferences.
BACKGROUND: NCT05922982.