To revise the "Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult" published in Critical Care Medicine in 2002.
The American College of ...Critical Care Medicine assembled a 20-person, multidisciplinary, multi-institutional task force with expertise in guideline development, pain, agitation and sedation, delirium management, and associated outcomes in adult critically ill patients. The task force, divided into four subcommittees, collaborated over 6 yr in person, via teleconferences, and via electronic communication. Subcommittees were responsible for developing relevant clinical questions, using the Grading of Recommendations Assessment, Development and Evaluation method (http://www.gradeworkinggroup.org) to review, evaluate, and summarize the literature, and to develop clinical statements (descriptive) and recommendations (actionable). With the help of a professional librarian and Refworks database software, they developed a Web-based electronic database of over 19,000 references extracted from eight clinical search engines, related to pain and analgesia, agitation and sedation, delirium, and related clinical outcomes in adult ICU patients. The group also used psychometric analyses to evaluate and compare pain, agitation/sedation, and delirium assessment tools. All task force members were allowed to review the literature supporting each statement and recommendation and provided feedback to the subcommittees. Group consensus was achieved for all statements and recommendations using the nominal group technique and the modified Delphi method, with anonymous voting by all task force members using E-Survey (http://www.esurvey.com). All voting was completed in December 2010. Relevant studies published after this date and prior to publication of these guidelines were referenced in the text. The quality of evidence for each statement and recommendation was ranked as high (A), moderate (B), or low/very low (C). The strength of recommendations was ranked as strong (1) or weak (2), and either in favor of (+) or against (-) an intervention. A strong recommendation (either for or against) indicated that the intervention's desirable effects either clearly outweighed its undesirable effects (risks, burdens, and costs) or it did not. For all strong recommendations, the phrase "We recommend …" is used throughout. A weak recommendation, either for or against an intervention, indicated that the trade-off between desirable and undesirable effects was less clear. For all weak recommendations, the phrase "We suggest …" is used throughout. In the absence of sufficient evidence, or when group consensus could not be achieved, no recommendation (0) was made. Consensus based on expert opinion was not used as a substitute for a lack of evidence. A consistent method for addressing potential conflict of interest was followed if task force members were coauthors of related research. The development of this guideline was independent of any industry funding.
These guidelines provide a roadmap for developing integrated, evidence-based, and patient-centered protocols for preventing and treating pain, agitation, and delirium in critically ill patients.
Non-operative management (NOM) is accepted treatment of splenic injury, but this may fail leading to splenectomy. Splenic artery embolization (SAE) may improve rate of salvage. The purpose is to ...determine the cost-utility of the addition of SAE for high-grade splenic injuries.
A cost-utility analysis was developed to compared NOM to SAE in patients with blunt splenic injury. Sensitivity analysis was completed to account for uncertainty. Utility outcome was quality-adjusted life years (QALY).
For patients with grade III, IV and V injury NOM is the dominant strategy. The probability of NOM being the more cost-effective strategy is 87.5% in patients with grade V splenic injury. SAE is not the favored strategy unless the probability of failure of NOM is greater than 70.0%.
For grade III–V injuries, NOM without SAE yields more quality-adjusted life years. NOM without SAE is the most cost-effective strategy for high-grade splenic injuries.
•Addition of splenic angioembolization is thought to improve care in blunt splenic injury.•Splenic angioembolization adds costs but does not add quality adjusted life years.•Non-operative management of blunt splenic injury is cost effective.•It is safe to treat hemodynamically stable patients with non-operative management alone.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
IMPORTANCE: Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI. OBJECTIVE: To determine ...whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher. INTERVENTIONS: Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309). MAIN OUTCOMES AND MEASURES: The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 moderate disability or good recovery) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 no disability to 30 death), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events. RESULTS: Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 74% male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month follow-up. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; 90% 1-sided confidence limit for benefit, −0.9%; P = .16; 97.5% 1-sided confidence limit for harm, 10.2%; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, −2.9% 95% CI, −7.9% to 2.1%; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, −0.9 95% CI, −2.5 to 0.7; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, −5.4% 95% CI, −12.8% to 2.1%; P = .16). CONCLUSIONS AND RELEVANCE: Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01990768
To revise the "Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult" published in Critical Care Medicine in 2002.
The American College of ...Critical Care Medicine assembled a 20-person, multidisciplinary, multi-institutional task force with expertise in guideline development, pain, agitation and sedation, delirium management, and associated outcomes in adult critically ill patients. The task force, divided into four subcommittees, collaborated over six years in person, via teleconferences, and via electronic communication. Subcommittees were responsible for developing relevant clinical questions, using the Grading of Recommendations Assessment, Development and Evaluation method (www.gradeworkinggroup.org) to review, evaluate, and summarize the literature, and to develop clinical statements (descriptive) and recommendations (actionable). With the help of a professional librarian and Refworks database software, they developed a Web-based electronic database of over 19,000 references extracted from eight clinical search engines, related to pain and analgesia, agitation and sedation, delirium, and related clinical outcomes in adult ICU patients. The group also used psychometric analyses to evaluate and compare pain, agitation/sedation, and delirium assessment tools. All task force members were allowed to review the literature supporting each statement and recommendation and provided feedback to the subcommittees. Group consensus was achieved for all statements and recommendations using the nominal group technique and the modified Delphi method, with anonymous voting by all task force members using E-Survey (www.esurvey.com). All voting was completed in December 2010. Relevant studies published after this date and prior to publication of these guidelines were referenced in the text. The quality of evidence for each statement and recommendation was ranked as high (A), moderate (B), or low/very low (C). The strength of recommendations was ranked as strong (1) or weak (2) and either in favor of (+) or against (-) an intervention. A strong recommendation (either for or against) indicated that the intervention's desirable effects either clearly outweighed its undesirable effects (risks, burdens, and costs) or it did not. For all strong recommendations, the phrase "We recommend..." is used throughout. A weak recommendation, either for or against an intervention, indicated that the tradeoff between desirable and undesirable effects was less clear. For all weak recommendations, the phrase "We suggest..." is used throughout. In the absence of sufficient evidence, or when group consensus could not be achieved, no recommendation (0) was made. Consensus based on expert opinion was not used as a substitute for a lack of evidence. A consistent method for addressing potential conflicts of interest was followed if task force members were coauthors of related research. The development of this guideline was independent of any industry funding.
These guidelines provide a roadmap for developing integrated, evidence-based, and patient-centered protocols for preventing and treating pain, agitation, and delirium in critically ill patients.
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DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
Thoracic trauma is the second most prevalent nonintentional injury in the United States and is associated with significant morbidity. Analgesia for blunt thoracic trauma was first addressed by the ...Eastern Association for the Surgery of Trauma (EAST) with a practice management guideline published in 2005. Since that time, it was hypothesized that there have been advances in the analgesic management for blunt thoracic trauma. As a result, updated guidelines for this topic using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) framework recently adopted by EAST are presented.
Five systematic reviews were conducted using multiple databases. The search retrieved articles regarding analgesia for blunt thoracic trauma from January1967 to August 2015. Critical outcomes of interest were analgesia, postoperative pulmonary complications, changes in pulmonary function tests, need for endotracheal intubation, and mortality. Important outcomes of interest examined included hospital and intensive care unit length of stay.
Seventy articles were identified. Of these, 28 articles were selected to construct the guidelines. The overall risk of bias for all studies was high. The majority of included studies examined epidural analgesia. Epidural analgesia was associated with lower short-term pain scores in most studies, but the quality and quantity of evidence were very low, and no firm evidence of benefit or harm was found when this modality was compared with other analgesic interventions. The quality of evidence for paravertebral block, intrapleural analgesia, multimodal analgesia, and intercostal nerve blocks was very low as assessed by GRADE. The limitations with the available literature precluded the formulation of strong recommendations by our panel.
We propose two evidence-based recommendations regarding analgesia for patients with blunt thoracic trauma. The overall risk of bias for all studies was high. The limitations with the available literature precluded the formulation of strong recommendations by our panel. We conditionally recommend epidural analgesia and multimodal analgesia as options for patients with blunt thoracic trauma, but the overall quality of evidence supporting these modalities is low in trauma patients. These recommendations are based on very low-quality evidence but place a high value on patient preferences for analgesia. These recommendations are in contradistinction to the previously published Practice Management Guideline published by EAST.
IMPORTANCE: Severely injured patients experiencing hemorrhagic shock often require massive transfusion. Earlier transfusion with higher blood product ratios (plasma, platelets, and red blood cells), ...defined as damage control resuscitation, has been associated with improved outcomes; however, there have been no large multicenter clinical trials. OBJECTIVE: To determine the effectiveness and safety of transfusing patients with severe trauma and major bleeding using plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio. DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, phase 3, multisite, randomized clinical trial of 680 severely injured patients who arrived at 1 of 12 level I trauma centers in North America directly from the scene and were predicted to require massive transfusion between August 2012 and December 2013. INTERVENTIONS: Blood product ratios of 1:1:1 (338 patients) vs 1:1:2 (342 patients) during active resuscitation in addition to all local standard-of-care interventions (uncontrolled). MAIN OUTCOMES AND MEASURES: Primary outcomes were 24-hour and 30-day all-cause mortality. Prespecified ancillary outcomes included time to hemostasis, blood product volumes transfused, complications, incidence of surgical procedures, and functional status. RESULTS: No significant differences were detected in mortality at 24 hours (12.7% in 1:1:1 group vs 17.0% in 1:1:2 group; difference, −4.2% 95% CI, −9.6% to 1.1%; P = .12) or at 30 days (22.4% vs 26.1%, respectively; difference, −3.7% 95% CI, −10.2% to 2.7%; P = .26). Exsanguination, which was the predominant cause of death within the first 24 hours, was significantly decreased in the 1:1:1 group (9.2% vs 14.6% in 1:1:2 group; difference, −5.4% 95% CI, −10.4% to −0.5%; P = .03). More patients in the 1:1:1 group achieved hemostasis than in the 1:1:2 group (86% vs 78%, respectively; P = .006). Despite the 1:1:1 group receiving more plasma (median of 7 U vs 5 U, P < .001) and platelets (12 U vs 6 U, P < .001) and similar amounts of red blood cells (9 U) over the first 24 hours, no differences between the 2 groups were found for the 23 prespecified complications, including acute respiratory distress syndrome, multiple organ failure, venous thromboembolism, sepsis, and transfusion-related complications. CONCLUSIONS AND RELEVANCE: Among patients with severe trauma and major bleeding, early administration of plasma, platelets, and red blood cells in a 1:1:1 ratio compared with a 1:1:2 ratio did not result in significant differences in mortality at 24 hours or at 30 days. However, more patients in the 1:1:1 group achieved hemostasis and fewer experienced death due to exsanguination by 24 hours. Even though there was an increased use of plasma and platelets transfused in the 1:1:1 group, no other safety differences were identified between the 2 groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01545232
Blunt cerebrovascular injuries (BCVIs) are associated with significant morbidity and mortality. This guideline evaluates several aspects of BCVI diagnosis and management including the role of ...screening protocols, criteria for screening cervical spine injuries, and the use of antithrombotic therapy (ATT) and endovascular stents.
Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, a taskforce of the Practice Management Guidelines Committee of the Eastern Association for the Surgery of Trauma performed a systematic review and meta-analysis of currently available evidence. Four population, intervention, comparison, and outcome questions were developed to address diagnostic and therapeutic issues relevant to BCVI.
A total of 98 articles were identified. Of these, 23 articles were selected to construct the guidelines. In these studies, the detection of BCVI increased with the use of a screening protocol versus no screening protocol (odds ratio OR, 4.74; 95% confidence interval CI, 1.76-12.78; p = 0.002), as well as among patients with high-risk versus low-risk cervical spine injuries (OR, 12.7; 95% CI, 6.24-25.62; p = 0.003). The use of ATT versus no ATT resulted in a decreased risk of stroke (OR, 0.20; 95% CI, 0.06-0.65; p < 0.0001) and mortality (OR, 0.17; 95% CI, 0.08-0.34; p < 0.0001). There was no significant difference in the risk of stroke among patients with Grade II or III injuries who underwent stenting as an adjunct to ATT versus ATT alone (OR, 1.63; 95% CI, 0.2-12.14; p = 0.63).
We recommend using a screening protocol to detect BCVI in blunt polytrauma patients. Among patients with high-risk cervical spine injuries, we recommend screening computed tomography angiography to detect BCVI. For patients with low-risk risk cervical injuries, we conditionally recommend performing a computed tomography angiography to detect BCVI. We recommend the use of ATT in patients diagnosed with BCVI. Finally, we recommend against the routine use of endovascular stents as an adjunct to ATT in patients with Grade II or III BCVIs.
Guidelines, Level III.
IMPORTANCE: It is not clear which severely injured patients with hemorrhagic shock may benefit most from a 1:1:1 vs 1:1:2 (plasma:platelets:red blood cells) resuscitation strategy. Identification of ...trauma molecular endotypes may reveal subgroups of patients with differential treatment response to various resuscitation strategies. OBJECTIVE: To derive trauma endotypes (TEs) from molecular data and determine whether these endotypes are associated with mortality and differential treatment response to 1:1:1 vs 1:1:2 resuscitation strategies. DESIGN, SETTING, AND PARTICIPANTS: This was a secondary analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) randomized clinical trial. The study cohort included individuals with severe injury from 12 North American trauma centers. The cohort was taken from the participants in the PROPPR trial who had complete plasma biomarker data available. Study data were analyzed on August 2, 2021, to October 25, 2022. EXPOSURES: TEs identified by K-means clustering of plasma biomarkers collected at hospital arrival. MAIN OUTCOMES AND MEASURES: An association between TEs and 30-day mortality was tested using multivariable relative risk (RR) regression adjusting for age, sex, trauma center, mechanism of injury, and injury severity score (ISS). Differential treatment response to transfusion strategy was assessed using an RR regression model for 30-day mortality by incorporating an interaction term for the product of endotype and treatment group adjusting for age, sex, trauma center, mechanism of injury, and ISS. RESULTS: A total of 478 participants (median IQR age, 34.5 25-51 years; 384 male 80%) of the 680 participants in the PROPPR trial were included in this study analysis. A 2-class model that had optimal performance in K-means clustering was found. TE-1 (n = 270) was characterized by higher plasma concentrations of inflammatory biomarkers (eg, interleukin 8 and tumor necrosis factor α) and significantly higher 30-day mortality compared with TE-2 (n = 208). There was a significant interaction between treatment arm and TE for 30-day mortality. Mortality in TE-1 was 28.6% with 1:1:2 treatment vs 32.6% with 1:1:1 treatment, whereas mortality in TE-2 was 24.5% with 1:1:2 treatment vs 7.3% with 1:1:1 treatment (P for interaction = .001). CONCLUSIONS AND RELEVANCE: Results of this secondary analysis suggest that endotypes derived from plasma biomarkers in trauma patients at hospital arrival were associated with a differential response to 1:1:1 vs 1:1:2 resuscitation strategies in trauma patients with severe injury. These findings support the concept of molecular heterogeneity in critically ill trauma populations and have implications for tailoring therapy for patients at high risk for adverse outcomes.
The emergent evaluation of children with suspected traumatic cervical spine injuries (CSI) remains a challenge. Pediatric clinical pathways have been developed to stratify the risk of CSI and guide ...computed tomography (CT) utilization. The cost-effectiveness of their application has not been evaluated. Our objective was to examine the cost-effectiveness of three common strategies for the evaluation of children with suspected CSI after blunt injury.
We developed a decision analytic model comparing these strategies to estimate clinical outcomes and costs for a hypothetical population of 0–17 year old patients with blunt neck trauma. Strategies included: 1) clinical pathway to stratify risk using NEXUS criteria and determine need for diagnostic testing; 2) screening radiographs as a first diagnostic; and 3) immediate CT scanning for all patients. We measured effectiveness with quality-adjusted life years (QALYs), and costs with 2018 U.S. dollars. Costs and effectiveness were discounted at 3% per year.
The use of the clinical pathway results in a gain of 0.04 QALYs and a cost saving of $2800 compared with immediate CT scanning of all patients. Use of the clinical pathway was less costly and more effective than immediate CT scan as long as the sensitivity of the clinical prediction rule was greater than 87% and when the sensitivity of x-ray was greater than 84%.
A strategy using a clinical pathway to first stratify risk before further diagnostic testing was less costly and more effective than either performing CT scanning or screening cervical radiographs on all patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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