Twelve tips for developing and implementing an effective critical care simulation programme.

Simulation training in healthcare settings has become a valuable training tool. It provides an ideal formative assessment for interdisciplinary teaching. It provides a high fidelity and highly immersive environment where healthcare staff and students can practice developing their skills in a safe and controlled manner. Simulation training allows staff to practice skills that better prepare them for clinical emergencies, therefore possibly optimising clinical care. While the benefits of simulation education are well understood, establishing a programme for use by critical care staff is complex. Complexities include the highly specialised scenarios that are not typically encountered in non-critical care areas, as well as the need for advanced monitoring equipment, ventilation equipment etc. These 12 tips are intended to assist healthcare educators in navigating the complexities in the establishment of a critical care simulation programme, providing advice on selecting target audiences, learning outcomes, creating a critical care simulation environment and recommendations on evaluation and development of the programme.

Pressure ulcer risk assessment in the ICU. Is it time for a more objective measure?

BACKGROUND: The Braden scale, one of the most widely used risk assessment tools is often criticized when used in the Intensive Care Unit. Most patients in the Intensive Care Unit are at risk of pressure ulcer development meaning that the Braden score will usually indicate high risk for these patients. This study set out to determine the correlation between Sub-Epidermal Moisture measurements and Braden scores among Intensive Care Unit patients. METHODS: This study employed an observational research design. Braden score was assessed on all study days (1-5), in addition to visual skin assessment and Sub-Epidermal Moisture measurements at the sacrum and heels. Sub-Epidermal Moisture measurements were categorised as low (<0.5), borderline abnormal (≥0.5), and high (≥0.8). Correlation was assessed between Sub-Epidermal Moisture levels and Braden scores. RESULTS: A total of 53 participants were recruited. The median (interquartile range) baseline Braden score was 9 (9-10) and 81 % (n = 43) of participants were at very high/high risk of pressure ulcer development. Braden scores remained relatively constant over time with little fluctuation in scores. 19 % (n = 10) of patients had normal (<0.5) Sub-Epidermal Moisture delta measurements on enrolment, and all developed abnormal measurements by day 2. There were no significant correlations between Braden scores and Sub-Epidermal Moisture measurements. CONCLUSION: Although this was not its original intention, a missing link with the Braden scale is that it does not provide information on how patients are responding to the adverse effects of pressure and shear forces. Furthermore, in patients who are critically unwell, most patients are classified as being "at risk" of pressure ulcer development. Therefore, an objective measure of how patients are responding to pressure and shear forces at different anatomical areas is needed. IMPLICATIONS TO CLINICAL PRACTICE: Sub-Epidermal Moisture measurements can offer more information, not only on identifying those who are at risk, but also how those patients are tolerating this risk at different anatomical sites.

Ethical considerations for the nursing care of Transgender patients in the Intensive Care Unit.

There is more discussion than ever surrounding the health and care needs of Transgender communities. However, there is limited research on the care of Transgender patients in the Intensive Care Unit which can contribute to knowledge gaps, inconsistencies and uncertainties surrounding health care practices. This article is not intended to address all of the specific needs of Transgender patients in ICU, but to explore the ethical considerations for caring for a Transgender woman in the ICU. In doing so, this article will explore some specific considerations around gender affirming care, challenging discrimination, physiological changes, and systems change to enhance care.

The impact of brain tissue oxygenation monitoring on the Glasgow Outcome Scale/Glasgow Outcome Scale Extended in patients with moderate to severe traumatic brain injury: A systematic review.

BACKGROUND: Traumatic brain injuries (TBIs) are one of the leading causes of death or long-term disability around the world. As a result of improvements in supportive care, patients are surviving more severe insults with more pronounced dependency on their families, hospitals, and long-term care facilities. The introduction of brain tissue oxygenation (PbtO2) monitoring aims to recognize episodes of reduced cerebral perfusion with and without associated increased intracranial pressure (ICP). AIM: The aim of this review is to determine the impact of PbtO2 on the Glasgow Outcome Scale/Glasgow Outcome Scale Extended (GOS/GOSE) in patients with moderate to severe TBI. DESIGN: Systematic review with narrative and meta-analysis. All original research in which adult patients undergoing PbtO2 were compared with a control group of traditional ICP/cerebral perfusion pressure (CPP) monitoring. Both randomized controlled trials and observational studies were included in this review. METHODS: Databases were searched in September 2022. The primary outcome of the review was the impact of PbtO2 monitoring on GOS/GOSE, while secondary outcomes were mortality and length of stay (LOS) in the intensive care unit (ICU). RESULTS: Seven studies with a combined number of 770 patients were included in the review. These patients were adults ≥16 years of age. Only two of the studies included found a statistically significant association between PbtO2 monitoring and improved long-term neurological outcomes in patients with TBI (p = .01, p < .01). A meta-analysis of the secondary outcomes identified an associated reduction of mortality in favour of the group treated with PbtO2 monitoring (p < .0001). Results from studies examining LOS in ICU have demonstrated an associated increase of LOS in ICU in patients treated with PbtO2-guided therapy. CONCLUSION: From the studies included in this review, only two found a statistically significant association between PbtO2 monitoring and long-term outcomes. It is unclear whether PbtO2 goal-directed therapy has a positive impact on the long-term neurological functions and mortality of patients suffering from TBI. A multicentre randomized controlled trial may provide further evidence, but not necessarily conclusive. RELEVANCE TO CLINICAL PRACTICE: Further research is warranted to determine the efficacy of the introduction of this new monitoring system to guide local policy change.

The role of proinflammatory cytokines in the detection of early pressure ulcer development: a systematic review.

OBJECTIVE: Pressure ulcers (PUs) commonly occur over bony prominences and are notoriously difficult to treat. Proinflammatory cytokines are substances that initiate the inflammatory process preceding PU development. The aim of this review was to assess whether the increased presence of proinflammatory cytokines could potentially be used as an early detection system for PU development. METHOD: A systematic search of publications using MEDLINE, CINAHL, and Cochrane databases was conducted in August 2020. Data were extracted and a narrative synthesis was undertaken. The evidence-based librarianship (EBL) checklist assessed the methodological quality of the included studies. The systematic review included original research studies, prospective design, and human studies written in English. Retrospective studies, animal studies, conference papers, opinion papers and qualitative methodology were excluded. No restrictions on the date of publication and study setting were applied. RESULTS: The six studies included were conducted between 2015 and 2019, 50% (n=3) used an experimental study design. The mean sample size was 15 participants (standard deviation=1.72). A total of seven proinflammatory cytokines were analysed. Statistically significant differences were found among inflammatory mediators. Overall results showed that the concentration of interleukin (IL)-1α significantly increased in each study. The EBL score varied between 77-88%. In total, 100% (n=6) of the studies scored ≥75%, reflecting validity. CONCLUSION: It is not yet certain that monitoring proinflammatory cytokines represents a noninvasive method that could potentially direct preventative measures to those who are identified as at high risk for developing PUs. IL-1α potentially may be elevated for other health conditions, not just PUs. Future studies are therefore recommended.

Pressure ulcers in patients with COVID-19 acute respiratory distress syndrome undergoing prone positioning in the intensive care unit: A pre- and post-intervention study.

BACKGROUND: Prone positioning has been widely used to improve oxygenation and reduce ventilator-induced lung injury in patients with severe COVID-19 acute respiratory distress syndrome (ARDS). One major complication associated with prone positioning is the development of pressure ulcers (PUs). AIM: This study aimed to determine the impact of a prevention care bundle on the incidence of PUs in patients with COVID-19 ARDS undergoing prone positioning in the intensive care unit. STUDY DESIGN: This was a single-centre pre and post-test intervention study which adheres to the Standards for Reporting Implementation Studies (StaRI) guidelines. The intervention included a care bundle addressing the following: increasing frequency of head turns, use of an open gel head ring, application of prophylactic dressings to bony prominences, use of a pressure redistribution air mattress, education of staff in the early identification of evolving PUs through regular and rigorous skin inspection and engaging in bedside training sessions with nursing and medical staff. The primary outcome of interest was the incidence of PU development. The secondary outcomes of interest were severity of PU development and the anatomical location of the PUs. RESULTS: In the pre-intervention study, 20 patients were included and 80% (n = 16) of these patients developed PUs, comprising 34 ulcers in total. In the post-intervention study, a further 20 patients were included and 60% (n = 12) of these patients developed PUs, comprising 32 ulcers in total. This marks a 25% reduction in the number of patients developing a PU, and a 6% decrease in the total number of PUs observed. Grade II PUs were the most prevalent in both study groups (65%, n = 22; 88%, n = 28, respectively). In the post-intervention study, there was a reduction in the incidence of grade III and deep tissue injuries (pre-intervention 6%, n = 2 grade III, 6% n = 2 deep tissue injuries; post-intervention no grade III ulcers, grade IV ulcers, or deep tissues injuries were recorded). However, there was an increase in the number of unstageable PUs in the post-intervention group with 6% (n = 2) of PUs being classified as unstageable, meanwhile there were no unstageable PUs in the pre-intervention group. This is an important finding to consider as unstageable PUs can indicate deep tissue damage and therefore need to be considered alongside PUs of a more severe grade (grade III, grade IV, and deep tissue injuries). CONCLUSION: The use of a new evidence-based care bundle for the prevention of PUs in the management of patients in the prone position has the potential to reduce the incidence of PU development. Although improvements were observed following alterations to standard practice, further research is needed to validate these findings. RELEVANCE TO CLINICAL PRACTICE: The use of a new, evidence-based care bundle in the management of patients in the prone position has the potential to reduce the incidence of PUs.

Measuring subepidermal moisture to detect early pressure ulcer development: a systematic review.

OBJECTIVE: The aim was to assess evidence related to the measuring of subepidermal moisture (SEM) to detect early, nonvisible development of pressure ulcers (PUs). METHOD: Using systematic review methodology, all quantitative animal and human research studies written in English were considered. In January 2021, PubMed, CINAHL, SCOPUS, Cochrane and EMBASE databases were searched. The primary outcome of interest was the validity of SEM measurement to detect early PU development. The secondary outcome was time to PU detection, sensitivity and specificity of SEM measurement, and the impact of SEM measurements on PU prevention. Data analysis was undertaken using RevMan and narrative synthesis. RESULTS: A total of 17 articles met the inclusion criteria. In all studies, a consistent abnormal deviation in SEM measurements corresponded with evidence of visual PU development. Time to PU development, explored in four studies, showed earlier detection of PU development using SEM measurement. RevMan analysis identified the mean difference in time to PU development (SEM measurement versus visual skin assessment, VSA) was 4.61 days (95% confidence interval: 3.94-5.28; p=0.0001) in favour of SEM measurements. The sensitivity of SEM measurements was reported in four studies, and scores varied from 48.3% to 100.0%. Specificity was also reported in four studies and scores ranged from 24.4% to 83.0%. The impact of the detection of abnormal SEM measurements on PU prevention was explored by one study. Results showed a 93% decrease in PU rates when staff acted on the results of the SEM readings. CONCLUSION: The findings of this review identified that SEM measurement detects PU development earlier than VSA. Furthermore, when staff responded to abnormal SEM measurements, prevention strategies were enhanced, with a subsequent reduction in visible PU development. SEM measurement may therefore be a useful addition to PU prevention strategies. DECLARATION OF INTEREST: The School of Nursing & Midwifery, RCSI has a research agreement with Bruin Biometrics. Funding for the study was through an Irish Research Council PhD Enterprise Partnership Scheme with Bruin Biometrics. The authors have no other conflicts of interest.

A randomized, double-blind, placebo-controlled trial of intravenous alpha-1 antitrypsin for ARDS secondary to COVID-19.

Background: Patients with severe coronavirus disease 2019 (COVID-19) develop a febrile pro-inflammatory cytokinemia with accelerated progression to acute respiratory distress syndrome (ARDS). Here we report the results of a phase 2, multicenter, randomized, double-blind, placebo-controlled trial of intravenous (IV) plasma-purified alpha-1 antitrypsin (AAT) for moderate to severe ARDS secondary to COVID-19 (EudraCT 2020-001391-15). Methods: Patients (n = 36) were randomized to receive weekly placebo, weekly AAT (Prolastin, Grifols, S.A.; 120 mg/kg), or AAT once followed by weekly placebo. The primary endpoint was the change in plasma interleukin (IL)-6 concentration at 1 week. In addition to assessing safety and tolerability, changes in plasma levels of IL-1ß, IL-8, IL-10, and soluble tumor necrosis factor receptor 1 (sTNFR1) and clinical outcomes were assessed as secondary endpoints. Findings: Treatment with IV AAT resulted in decreased inflammation and was safe and well tolerated. The study met its primary endpoint, with decreased circulating IL-6 concentrations at 1 week in the treatment group. This was in contrast to the placebo group, where IL-6 was increased. Similarly, plasma sTNFR1 was substantially decreased in the treatment group while remaining unchanged in patients receiving placebo. IV AAT did not definitively reduce levels of IL-1ß, IL-8, and IL-10. No difference in mortality or ventilator-free days was observed between groups, although a trend toward decreased time on ventilator was observed in AAT-treated patients. Conclusions: In patients with COVID-19 and moderate to severe ARDS, treatment with IV AAT was safe, feasible, and biochemically efficacious. The data support progression to a phase 3 trial and prompt further investigation of AAT as an anti-inflammatory therapeutic. Funding: ECSA-2020-009; Elaine Galwey Research Bursary.

Protease-anti-protease compartmentalization in SARS-CoV-2 ARDS: Therapeutic implications.

BACKGROUND: Interleukin-6 (IL-6) is elevated in SARS-CoV-2 infection. IL-6 regulates acute-phase proteins, such as alpha-1 antitrypsin (AAT), a key lung anti-protease. We investigated the protease-anti-protease balance in the circulation and pulmonary compartments in SARS-CoV-2 acute respiratory distress syndrome (ARDS) compared to non-SARS-CoV-2 ARDS (nsARDS) and the effects of tocilizumab (IL-6 receptor antagonist) on anti-protease defence in SARS-CoV-2 infection. METHODS: Levels and activity of AAT and neutrophil elastase (NE) were measured in plasma, airway tissue and tracheal secretions (TA) of people with SARS-CoV-2 ARDS or nsARDS. AAT and IL-6 levels were evaluated in people with moderate SARS-CoV-2 infection who received standard of care +/- tocilizumab. FINDINGS: AAT plasma levels doubled in SARS-CoV-2 ARDS. In lung parenchyma AAT levels were increased, as was the percentage of neutrophils involved in NET formation. A protease-anti-protease imbalance was detected in TA with active NE and no active AAT. The airway anti-protease, secretory leukoprotease inhibitor was decreased in SARS-CoV-2-infected lungs and cleaved in TA. In nsARDS, plasma AAT levels were elevated but TA samples had less AAT cleavage, with no detectable active NE in most samples. Induction of AAT in ARDS occurred mainly through IL-6. Tocilizumab down-regulated AAT during SARS-CoV-2 infection. INTERPRETATION: There is a protease-anti-protease imbalance in the airways of SARS-CoV-2-ARDS patients. This imbalance is a target for anti-protease therapy. FUNDING: NIH Serological Sciences Network, National Heart, Lung, and Blood Institute and National Institute of Diabetes and Digestive and Kidney Diseases.

Preventing facial pressure injuries among health care staff working in diverse COVID-19 care environments.

The aim of this study was to determine the impact of a specially designed care bundle on the development of facial pressure injuries among frontline health care workers wearing personal protective equipment (PPE) during the COVID-19 pandemic. This was a mixed methods study. First, a pre-posttest observational design was employed to evaluate the impact of the pre-piloted intervention, a care bundle including skin cleansing and hydration, protective material use, facemask selection and skin inspection, developed in line with international best practice guidelines. Data were collected using survey methodology. Frontline COVID-19 staff working in acute, community and ambulance services were invited to participate. Then, judgemental and volunteer sampling was used to select participants to undertake semi-structured interviews to elicit feedback on their perceptions of the care bundle. The sample included 120 acute hospital staff, 60 Ambulance staff, 24 Community Hub staff and 20 COVID-19 testing centre staff. A survey response rate of 61% was realised (n = 135/224). Of the participants, 32% (n = 43) had a facial pressure ulcer (FPI) pre-intervention and 13% (n = 18) developed an FPI while using the care bundle. The odds ratio (OR) was 0.33 (95% CI: 0.18 to 0.61; P = .0004), indicating a 77% reduction in the odds of FPI development with use of the care bundle. Analysis of the qualitative data from 22 interviews identified three key themes, the context for the care bundle, the ease of use of the care bundle and the care bundle as a solution to FPI development. The care bundle reduced the incidence of FPI among the participants and was found to be easy to use. Implementation of skin protection for frontline staff continues to be important given the persistently high incidence of COVID-19 and the ongoing need to wear PPE for protracted durations.

A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial.

OBJECTIVES: The primary objective is to demonstrate that, in patients with PCR-confirmed SARS-CoV-2 resulting in Acute Respiratory Distress Syndrome (ARDS), administration of 120mg/kg of body weight of intravenous Prolastin®(plasma-purified alpha-1 antitrypsin) reduces circulating plasma levels of interleukin-6 (IL-6). Secondary objectives are to determine the effects of intravenous Prolastin® on important clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs). TRIAL DESIGN: Phase 2, randomised, double-blind, placebo-controlled, pilot trial. PARTICIPANTS: The study will be conducted in Intensive Care Units in hospitals across Ireland. Patients with a laboratory-confirmed diagnosis of SARS-CoV-2-infection, moderate to severe ARDS (meeting Berlin criteria for a diagnosis of ARDS with a PaO2/FiO2 ratio <200 mmHg), >18 years of age and requiring invasive or non-invasive mechanical ventilation. All individuals meeting any of the following exclusion criteria at baseline or during screening will be excluded from study participation: more than 96 hours has elapsed from onset of ARDS; age < 18 years; known to be pregnant or breastfeeding; participation in a clinical trial of an investigational medicinal product (other than antibiotics or antivirals) within 30 days; major trauma in the prior 5 days; presence of any active malignancy (other than nonmelanoma skin cancer) which required treatment within the last year; WHO Class III or IV pulmonary hypertension; pulmonary embolism prior to hospital admission within past 3 months; currently receiving extracorporeal life support (ECLS); chronic kidney disease receiving dialysis; severe chronic liver disease with Child-Pugh score > 12; DNAR (Do Not Attempt Resuscitation) order in place; treatment withdrawal imminent within 24 hours; Prisoners; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; IgA deficiency. INTERVENTION AND COMPARATOR: Intervention: Either a once weekly intravenous infusion of Prolastin® at 120mg/kg of body weight for 4 weeks or a single dose of Prolastin® at 120mg/kg of body weight intravenously followed by once weekly intravenous infusion of an equal volume of 0.9% sodium chloride for a further 3 weeks. Comparator (placebo): An equal volume of 0.9% sodium chloride intravenously once per week for four weeks. MAIN OUTCOMES: The primary effectiveness outcome measure is the change in plasma concentration of IL-6 at 7 days as measured by ELISA. Secondary outcomes include: safety and tolerability of Prolastin® in the respective groups (as defined by the number of SAEs and AEs); PaO2/FiO2 ratio; respiratory compliance; sequential organ failure assessment (SOFA) score; mortality; time on ventilator in days; plasma concentration of alpha-1 antitrypsin (AAT) as measured by nephelometry; plasma concentrations of interleukin-1ß (IL-1ß), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TNF receptor 1 (sTNFR1, a surrogate marker for TNF-α) as measured by ELISA; development of shock; acute kidney injury; need for renal replacement therapy; clinical relapse, as defined by the need for readmission to the ICU or a marked decline in PaO2/FiO2 or development of shock or mortality following a period of sustained clinical improvement; secondary bacterial pneumonia as defined by the combination of radiographic findings and sputum/airway secretion microscopy and culture. RANDOMISATION: Following informed consent/assent patients will be randomised. The randomisation lists will be prepared by the study statistician and given to the unblinded trial personnel. However, the statistician will not be exposed to how the planned treatment will be allocated to the treatment codes. Randomisation will be conducted in a 1:1:1 ratio, stratified by site and age. BLINDING (MASKING): The investigator, treating physician, other members of the site research team and patients will be blinded to treatment allocation. The clinical trial pharmacy personnel and research nurses will be unblinded to facilitate intervention and placebo preparation. The unblinded individuals will keep the treatment information confidential. The infusion bag will be masked at the time of preparation and will be administered via a masked infusion set to maintain blinding. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 36 patients will be recruited and randomised in a 1:1:1 ratio to each of the trial arms. TRIAL STATUS: In March 2020, version 1.0 of the trial protocol was submitted to the local research ethics committee (REC), Health Research Consent Declaration Committee (HRCDC) and the Health Products regulatory Authority (HPRA). REC approval was granted on April 1st 2020, HPRA approval was granted on April 24th 2020 and the HRCDC provided a conditional declaration on April 17th 2020. In July 2020 a substantial amendment (version 2.0) was submitted to the REC, HRCDC and HPRA. Protocol changes in this amendment included: the addition of trial sites; extending the duration of the trial to 12 months from 3 months; removal of inclusion criteria requiring the need for vasopressors; amendment of randomisation schedule to stratify by age only and not BMI and sex; correction of grammatical error in relation to infusion duration; to allow for inclusion of subjects who may have been enrolled in a clinical trial involving either antibiotics or anti-virals in the past 30 days; to allow for inclusion of subjects who may be currently enrolled in a clinical trial involving either antibiotics or anti-virals; to remove the need for exclusion based on alpha-1 antitrypsin phenotype; removal of mandatory isoelectric focusing of plasma to confirm Pi*MM status at screening; removal of need for mandatory echocardiogram at screening; amendment on procedures around plasma analysis to reflect that this will be conducted at the central site laboratory (as trial is multi-site and no longer single site); wording amended to reflect that interim analysis of cytokine levels taken at 7 days may be conducted. HRCDC approved version 2.0 on September 14th 2020, and HPRA approved on October 22nd 2020. REC approved the substantial amendment on November 23rd. In November 2020, version 3.0 of the trial protocol was submitted to the REC and HPRA. The rationale for this amendment was to allow for patients with moderate to severe ARDS from SARS-CoV-2 with non-invasive ventilation. HPRA approved this amendment on December 1st 2020 and the REC approved the amendment on December 8th 2020. Patient recruitment commenced in April 2020 and the last patient will be recruited to the trial in April 2021. The last visit of the last patient is anticipated to occur in April 2021. At time of writing, patient recruitment is now complete, however follow-up patient visits and data collection are ongoing. TRIAL REGISTRATION: EudraCT 2020-001391-15 (Registered 31 Mar 2020). FULL PROTOCOL: The full protocol (version 3.0 23.11.2020) is attached as an additional file accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).