BACKGROUND: Compared with the operating room, tracheal intubations in the intensive care unit (ICU) are associated with worsened glottic view, decreased first-time success rate and increase in the technical difficulty of intubation and incidence of complications. Videolaryngoscopes (VLs) have been proposed to improve airway management, and while recent studies have confirmed that VLs improve intubation conditions in this patient population, there remains a lack of clarity regarding the selection between a standard Macintosh blade or a hyperangulated one, to determine which yields the best outcomes. The purpose of this study was to compare successful intubation on the first attempt with the Macintosh VL versus the hyperangulated VL during tracheal intubation in ICU patients. We hypothesise that tracheal intubation using the hyperangulated VL will improve the frequency of successful intubation on the first attempt.
METHODS: The INtubation VIdeolaryngoscopy BLADE-ICU trial is a prospective, multicentre, open-label, interventional, randomised, controlled superiority study conducted in 29 ICUs in Spain. Patients will be randomly assigned in a 1:1 ratio to undergo intubation using a Macintosh VL (control group) or a hyperangulated VL (experimental group) for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcomes include the time to intubation, attempts for successful intubation, laryngoscopic vision assessed with the modified Cormack-Lehane scale, the need for adjuvant airway devices for intubation, difficulty assessed by the anaesthesiologist and complications during tracheal intubation. Enrolment began on 1 May 2024 and is expected to be completed in 2025.
BACKGROUND: The study protocol was approved on 29 February 2024, by the Ethics Committee of Galicia (CEImG, code No. 2024-031).The results will be submitted for publication in a peer-reviewed journal.
BACKGROUND: NCT06322719.

BACKGROUND: Emergency resuscitative thoracotomy (ERT) is a resource-intensive procedure that can deplete a combat surgical team\'s supply and divert attention from casualties with more survivable injuries. An understanding of survival after ERT in the combat trauma population will inform surgical decision-making.
METHODS: We requested all encounters from 2007 to 2023 from the Department of Defense Trauma Registry (DoDTR). We analysed any documented thoracotomy in the emergency department and excluded any case for which it was not possible to distinguish ERT from operating room thoracotomy. The primary outcome was 24-hour mortality.
RESULTS: There were 48 301 casualties within the original dataset. Of those, 154 (0.3%) received ERT, with 114 non-survivors and 40 survivors at 24 hours. There were 26 (17%) survivors at 30 days. The majority were performed in role 3. The US military made up the largest proportion among the non-survivors and survivors. Explosives predominated in both groups (61% and 65%). Median Composite Injury Severity Scores were lower among the non-survivors (19 vs 33). Non-survivors had a lower proportion of serious head injuries (13% vs 40%) and thorax injuries (32% vs 58%). Median RBC consumption was lower among non-survivors (10 units vs 19 units), as was plasma (6 vs 16) and platelets (0 vs 3). The most frequent interventions and surgical procedures were exploratory thoracotomy (n=140), chest thoracostomy (n=137), open cardiac massage (n=131) and closed cardiac massage (n=121).
CONCLUSIONS: ERT in this group of combat casualties resulted in 26% survival at 24 hours. Although this proportion is higher than that reported in civilian data, more rigorous prospective studies would need to be conducted or improvement in the DoDTR data capture methods would need to be implemented to determine the utility of ERT in combat populations.

BACKGROUND: Poor communication about serious injury in older adults can lead to treatment that is inconsistent with patient preferences, create conflict and strain healthcare resources. We developed a communication intervention called Best Case/Worst Case-intensive care unit (ICU) that uses daily scenario planning, that is, a narrative description of plausible futures, to support prognostication and facilitate dialogue among patients, their families and the trauma ICU team. This article describes a protocol for a multisite, randomised, stepped-wedge study to test the effectiveness of the intervention on the quality of communication (QOC) in the ICU.
METHODS: We will follow all patients aged 50 and older admitted to the trauma ICU for 3 or more days after a serious injury at eight high-volume level 1 trauma centres. We aim to survey one family or \'like family\' member per eligible patient 5-7 days following their loved ones\' admission and clinicians providing care in the trauma ICU. Using a stepped-wedge design, we will use permuted block randomisation to assign the timing for each site to begin implementation of the intervention and routine use of the Best Case/Worst Case-ICU tool. We will use a linear mixed-effects model to test the effect of the tool on family-reported QOC (using the QOC scale) as compared with usual care. Secondary outcomes include the effect of the tool on reducing clinician moral distress (using the Measure of Moral Distress for Healthcare Professionals scale) and patients\' length of stay in the ICU.
BACKGROUND: Institutional review board (IRB) approval was granted at the University of Wisconsin, and all study sites ceded review to the primary IRB. We plan to report results in peer-reviewed publications and national meetings.
BACKGROUND: NCT05780918.

BACKGROUND: Acute respiratory failure is a life-threatening condition frequently found in the emergency department. High-flow nasal oxygen (HFNO) is increasingly used in emergency departments for patients with hypoxaemic acute respiratory failure. However, despite the increasing number of studies, its potential advantages regarding the need for therapeutic escalation and mortality have not been precisely evaluated. Our objective is to compare conventional oxygen therapy to HFNO when they are initiated during the first hour following the patient\'s arrival at the emergency department, with the hypothesis that HFNO would reduce the need for ventilatory therapy escalation.
METHODS: This is a multicentric, prospective, open and randomised superiority study. 500 inpatients will be randomised (1:1) to receive conventional oxygen therapy or HNFO. The primary outcome is a failure in the oxygen therapy defined as the need for a therapeutic escalation within 4 hours after therapy initiation.
BACKGROUND: The study has been submitted and approved by the Comité de Protection des Personnes Nord Ouest IV (20 October 2020). As required, a notification was sent to the Agence nationale de sécurité du médicament et des produits de santé (22 October 2020). The research results will be published in peer-reviewed publications and presented at international conferences.
BACKGROUND: NCT04607967.

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.