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.

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 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: Severe septic cardiomyopathy (SCM) is one of the main causes of refractory septic shock (RSS), with a high mortality. The application of venoarterial extracorporeal membrane oxygenation (ECMO) to support the impaired cardiac function in patients with septic shock remains controversial. Moreover, no prospective studies have been taken to address whether venoarterial ECMO treatment could improve the outcome of patients with sepsis-induced cardiogenic shock. The objective of this study is to assess whether venoarterial ECMO treatment can improve the 30-day survival rate of patients with sepsis-induced refractory cardiogenic shock.
METHODS: ExtraCorporeal Membrane Oxygenation in the therapy for REfractory Septic shock with Cardiac function Under Estimated is a prospective, multicentre, non-randomised, cohort study on the application of ECMO in SCM. At least 64 patients with SCM and RSS will be enrolled in an estimated ratio of 1:1.5. Participants taking venoarterial ECMO during the period of study are referred to as cohort 1, and patients receiving only conventional therapy without ECMO belong to cohort 2. The primary outcome is survival in a 30-day follow-up period. Other end points include survival to intensive care unit (ICU) discharge, hospital survival, 6-month survival, quality of life for long-term survival (EQ-5D score), successful rate of ECMO weaning, long-term survivors\' cardiac function, the number of days alive without continuous renal replacement therapy, mechanical ventilation and vasopressor, ICU and hospital length of stay, the rate of complications potentially related to ECMO treatment.
BACKGROUND: The trial has been approved by the Clinical Research and Application Institutional Review Board of the Second Affiliated Hospital of Guangzhou Medical University (2020-hs-51). Participants will be screened and enrolled from ICU patients with septic shock by clinicians, with no public advertisement for recruitment. Results will be disseminated in research journals and through conference presentations.
BACKGROUND: NCT05184296.

OBJECTIVE: This study aims to investigate the diagnostic value of heparin-binding protein (HBP) in sepsis and develop a sepsis diagnostic model incorporating HBP with key biomarkers and disease-related scores for rapid, and accurate diagnosis of sepsis in the intensive care unit (ICU).
METHODS: Clinical retrospective cross-sectional study.
METHODS: A comprehensive teaching tertiary hospital in China.
METHODS: Adult patients (aged ≥18 years) who underwent HBP testing or whose blood samples were collected when admitted to the ICU.
METHODS: HBP, C reactive protein (CRP), procalcitonin (PCT), white blood cell count (WBC), interleukin-6 (IL-6), lactate (LAC), Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) score were recorded.
RESULTS: Between March 2019 and December 2021, 326 patients were enrolled in this study. The patients were categorised into a non-infection group (control group), infection group, sepsis group and septic shock group based on the final diagnosis. The HBP levels in the sepsis group and septic shock group were 45.7 and 69.0 ng/mL, respectively, which were significantly higher than those in the control group (18.0 ng/mL) and infection group (24.0 ng/mL) (p<0.001). The area under the curve (AUC) value of HBP for diagnosing sepsis was 0.733, which was lower than those corresponding to PCT, CRP and SOFA but higher than those of IL-6, LAC and APACHE II. Multivariate logistic regression analysis identified HBP, PCT, CRP, IL-6 and SOFA as valuable indicators for diagnosing sepsis. A sepsis diagnostic model was constructed based on these indicators, with an AUC of 0.901, a sensitivity of 79.7% and a specificity of 86.9%.
CONCLUSIONS: HBP could serve as a biomarker for the diagnosis of sepsis in the ICU. Compared with single indicators, the sepsis diagnostic model constructed using HBP, PCT, CRP, IL-6 and SOFA further enhanced the diagnostic performance of sepsis.

OBJECTIVE: There was no evidence regarding the relationship between septic shock and tracheal injury scores. Investigate whether septic shock was independently associated with tracheal injury scores in intensive care unit (ICU) patients with invasive ventilation.
METHODS: Prospective observational cohort study.
METHODS: Our study was conducted in a Class III hospital in Hebei province, China.
METHODS: Patients over 18 years of age admitted to the ICU between 31 May 2020 and 3 May 2022 with a tracheal tube and expected to be on the tube for more than 24 hours.
METHODS: Tracheal injuries were evaluated by examining hyperaemia, ischaemia, ulcers and tracheal perforation by fiberoptic bronchoscope. Depending on the number of lesions, the lesions were further classified as moderate, severe or confluent.
RESULTS: Among the 97 selected participants, the average age was 56.6±16.5 years, with approximately 64.9% being men. The results of adjusted linear regression showed that septic shock was associated with tracheal injury scores (β: 2.99; 95% CI 0.70 to 5.29). Subgroup analysis revealed a stronger association with a duration of intubation ≥8 days (p=0.013).
CONCLUSIONS: Patients with septic shock exhibit significantly higher tracheal injury scores compared with those without septic shock, suggesting that septic shock may serve as an independent risk factor for tracheal injury.
BACKGROUND: ChiCTR2000037842, registered 03 September 2020. Retrospectively registered, https://www.chictr.org.cn/edit.aspx?pid=57011&htm=4.

BACKGROUND: Venous access in patients with obesity presents significant challenges. The success of central venous catheterisation largely depends on the cross-sectional area (CSA) of the internal jugular vein (IJV). While techniques like the Trendelenburg position have been traditionally used to increase IJV CSA, recent studies suggest its ineffectiveness in patients with obesity. Conversely, the potential of the effect of passive leg raising (PLR) has not been thoroughly investigated in this group of patients.
METHODS: This protocol outlines a planned randomised controlled trial to evaluate the effect of PLR on the CSA of the IJV in patients with obesity slated for central venous catheterisation. The protocol involves dividing 40 participants into two groups: one undergoing PLR and another serving as a control group without positional change. The protocol specifies measuring the CSA of the IJV via ultrasound as the primary outcome. Secondary outcomes will include the success rates of right IJV cannulation. The proposed statistical approach includes the use of t-tests to compare the changes in CSA between the two groups, with a significance threshold set at p<0.05.
UNASSIGNED: This study has been approved by the Institutional Review Board of Shanghai Tongren Hospital. All the participants will provide informed consent prior to enrolment in the study. Regarding the dissemination of research findings, we plan to share the results through academic conferences and peer-reviewed publications. Additionally, we will communicate our findings to the public and professional communities, including patient advocacy groups.
BACKGROUND: ChiCTR: ChiCTR2400080513.

BACKGROUND: Severe pneumonia (SP) stands as one of the most prevalent critical illnesses encountered in clinical practice, characterised by its rapid onset and progression, numerous complications and elevated mortality rates. While modern medical interventions primarily focus on symptomatic management such as anti-infective therapy and mechanical ventilation, challenges including high drug resistance and suboptimal therapeutic outcomes for certain patients persist. Dry cupping as an ancient practice with over a millennium of clinical use in China is renowned for its convenience and perceived clinical efficacy in various illnesses. Nevertheless, the lack of well-designed studies assessing its effects remains a notable gap in the literature. This protocol describes a placebo-controlled, randomised, single-blind study to evaluate the efficacy and safety of dry cupping as an adjuvant treatment for SP.
METHODS: 66 patients diagnosed with SP, aged 18-80 years, will be randomly divided into two groups: intervention group, receiving 10 times of dry cupping treatment; control group, receiving placebo dry cupping therapy. Both applications are used in bilateral Fei Shu (BL13), Pi Shu (BL21) and Shen Shu (BL22) cupping. The application will be conducted once a day for 10 days. Participants will be assessed before treatment (D0), after the first intervention (D1), after the fifth intervention (D5) and after treatment ended (D10). The assessments include blood oxygen saturation, respiratory rate, traditional Chinese medicine symptom score, inflammatory response, mechanical ventilation time and oxygen condition.
BACKGROUND: This protocol has been approved by the Ethics Committee of Shanghai Seventh People\'s Hospital (2023-7th-HIBR-070). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings.
BACKGROUND: ChiCTR2300076958.

OBJECTIVE: The association between haemoglobin-to-red blood cell distribution width ratio (HRR) and all-cause mortality remains poorly understood. This study aimed to examine the influence of HRR at the time of admission mortality over 1 year and 30 days in patients with sepsis.
METHODS: This was a secondary analysis.
METHODS: This study was conducted in intensive care units (ICUs).
METHODS: Adult patients with sepsis were identified and included from an intensive care database based on eligibility criteria.
UNASSIGNED: The primary outcome was the rate of death within 1 year. The secondary outcome was the death rate within 30 days.
RESULTS: A total of 4233 patients with sepsis who met the inclusion criteria were analysed, excluding those ineligible. These participants were divided into quartiles based on their HRR at admission. The overall mortality rates at 1 year and 30 days were 42.9% and 25.5%, respectively. A significant inverse association was observed between HRR quartiles and all-cause mortality (p<0.001). Pairwise comparisons using Kaplan-Meier analysis showed significant differences in 1-year mortality rates across the quartiles. However, no significant difference was detected in 30-day mortality between the Q3 and Q4 groups (p=0.222). Multivariate Cox regression analysis demonstrated that a higher HRR at ICU admission was independently associated with reduced mortality at 1 year (HR, 0.935; 95% CI 0.913 to 0.958; p<0.001) and 30 days (HR, 0.969; 95% CI 0.939 to 0.999; p=0.043). Furthermore, restricted cubic spline models indicated a non-linear relationship between HRR and mortality at both 1 year and 30 days (p<0.001 for both).
CONCLUSIONS: This retrospective analysis demonstrated that the HRR at the time of admission was a significant prognostic marker for long-term mortality in patients with sepsis.