Ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of the randomised UNIVERSAL trial.

BACKGROUND: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear. AIMS: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures. METHODS: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days. RESULTS: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004). CONCLUSIONS: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.

Design and Rationale of Routine UltrasouNd GuIdance for Vascular AccEss foR Cardiac Procedures: A Randomized TriaL (UNIVERSAL).

Background: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared to radial access. Ultrasound (US)-guided femoral access may reduce major vascular complications and bleeding. We aim to determine whether routinely using US guidance for femoral arterial access for coronary angiography or intervention will reduce Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complications. Methods: The Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial (UNIVERSAL) is a multicentre, prospective, open-label, randomized trial with blinded outcomes assessment. Patients undergoing coronary angiography with or without intervention via a femoral approach with fluoroscopic guidance will be randomized 1:1 to US-guided femoral access, compared to no US. The primary outcome is the composite of major bleeding based on the BARC 2, 3, or 5 criteria or major vascular complications within 30 days. The trial is designed to have 80% power and a 2-sided alpha level of 5% to detect a 50% relative risk reduction for the primary outcome based on a control event rate of 14%. Results: We completed enrollment on April 29, 2022, with 621 randomized patients. The patients had a mean age of 71 years (25.4% female), with a high rate of comorbidities, as follows: 45% had a prior percutaneous coronary intervention; 57% had previous coronary artery bypass surgery; and 18% had peripheral vascular disease. Conclusions: The UNIVERSAL trial will be one of the largest randomized trials of US-guided femoral access and has the potential to change guidelines and increase US uptake for coronary procedures worldwide.

Introduction: Par rapport à l'abord radial, la limitation importante de l'abord artériel fémoral lors des interventions au cœur pose un risque accru de complications vasculaires et de saignements. L'abord fémoral guidé par ultrasons (US) peut contribuer à réduire les complications vasculaires majeures et les saignements. Nous avons pour objectif de déterminer si l'utilisation systématique du guidage par US pour l'abord artériel fémoral lors des angiographies ou des interventions coronariennes contribuera à réduire les saignements de type 2, 3 ou 5 selon le B leeding A cademic R esearch C onsortium (BARC) ou les complications vasculaires majeures. Méthodes: L' U ltrasou n d Gu i dance for V ascular Acc e ss fo r Cardiac Procedure s : A Randomized Tria l (UNIVERSAL) est un essai multicentrique, prospectif, ouvert, à répartition aléatoire, réalisé par une évaluation à l'insu des résultats. Les patients subissant une angiographie coronarienne avec ou sans intervention par voie fémorale sous guidage fluoroscopique seront répartis de façon aléatoire 1:1 à l'abord fémoral guidé par US ou sans US. Le principal critère d'évaluation est le critère composite de saignements majeurs de type 2, 3 ou 5 selon les critères du BARC ou de complications vasculaires majeures dans les 30 jours. L'essai est conçu de façon à avoir une puissance de 80 % et un seuil alpha bilatéral de 5 % pour déterminer la réduction du risque relatif de 50 % du critère d'évaluation principal selon un taux d'événements dans le groupe témoin de 14 %. Résultats: Le 29 avril 2022, nous avons terminé le recrutement de 621 patients choisis aléatoirement. Les patients avaient un âge moyen de 71 ans (25,4 % de femmes) et un taux élevé de comorbidités : 45 % avaient déjà subi une intervention coronarienne percutanée, 57 % avaient déjà subi un pontage aorto-coronarien et 18 % avaient une maladie vasculaire périphérique. Conclusions: L'essai UNIVERSAL qui sera l'un des plus vastes essais à répartition aléatoire sur l'abord fémoral guidé par US a le potentiel de faire changer les lignes directrices et de faire augmenter le recours aux US lors des interventions coronariennes dans le monde entier.

Academic and Community ICUs Participating in a Critical Care Randomized Trial: A Comparison of Patient Characteristics and Trial Metrics.

Clinical research in Canada is conducted primarily in "academic" hospitals, whereas most clinical care is provided in "community" hospitals. The objective of this nested observational study was to compare patient characteristics, outcomes, process-of-care variables, and trial metrics for patients enrolled in a large randomized controlled trial who were admitted to academic and community hospitals in Canada. DESIGN: We conducted a preplanned observational study nested within the Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT, a randomized controlled trial comparing probiotics to placebo in mechanically ventilated patients) Research Program. SETTING: ICUs. PATIENTS: Mechanically ventilated patients. MEASUREMENTS: We compared patient characteristics, interventions, outcomes, and trial metrics between patients enrolled in PROSPECT from academic and community hospitals. MAIN RESULTS: Participating centers included 34 (82.9%) academic and seven (17.1%) community hospitals, which enrolled 2,203 (86.2%) and 352 (13.8%) patients, respectively. Compared with academic hospitals, patients enrolled in community hospitals were older (mean [sd] 62.7 yr [14.9 yr] vs 59.5 yr [16.4 yr]; p = 0.044), had longer ICU stays (median [interquartile range {IQR}], 13 d [8-23 d] vs 11 d [7-8 d]; p = 0.012) and higher mortality (percentage, [95% CI] in the ICU, 30.4% [25.8-35.4%]vs 20.5% [18.9-11.3%]; p = 0.002) and hospital (40.6% [35.6-45.8%] vs 26.1% [24.3-27.9%]; p < 0.001). Trial metrics, including informed consent rate (85.9% vs 76.3%; p = 0.149), mean (sd) monthly enrolment rate (2.1 [1.4] vs 1.1 [0.7]; p = 0.119), and protocol adherence (90.6% vs 91.6%; p = 0.207), were similar between community and academic ICUs. CONCLUSIONS: Community hospitals can conduct high-quality research, with similar trial metrics to academic hospitals. Patient characteristics differed between community and academic hospitals, highlighting the need for broader engagement of community hospitals in clinical research to ensure generalizability of study results.

Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures: The UNIVERSAL Randomized Clinical Trial.

Importance: A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared with radial access. Strategies to make femoral access safer are needed. Objective: To determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications. Design, Setting, and Participants: The Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial is a multicenter, prospective, open-label trial of ultrasonography-guided femoral access vs no ultrasonography for coronary angiography or intervention with planned femoral access. Patients were randomized from June 26, 2018, to April 26, 2022. Patients with ST-elevation myocardial infarction were not eligible. Interventions: Ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking. Main Outcomes and Measures: The primary composite outcome is the composite of major bleeding based on the Bleeding Academic Research Consortium 2, 3, or 5 criteria or major vascular complications within 30 days. Results: A total of 621 patients were randomized at 2 centers in Canada (mean [SD] age, 71 [10.24] years; 158 [25.4%] female). The primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group vs 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; P = .25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; P = .78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; P = .18). Ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; P < .001) and reduced the number of arterial puncture attempts (mean [SD], 1.2 [0.5] vs 1.4 [0.8]; mean difference, -0.26 [95% CI, -0.37 to -0.16]; P < .001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; P < .001) with similar times to access (mean [SD], 114 [185] vs 129 [206] seconds; mean difference, -15.1 [95% CI, -45.9 to 15.8]; P = .34). All prerandomization prespecified subgroups were consistent with the overall finding. Conclusions and Relevance: In this randomized clinical trial, use of ultrasonography for femoral access did not reduce bleeding or vascular complications. However, ultrasonography did reduce the risk of venipuncture and number of attempts. Larger trials may be required to demonstrate additional potential benefits of ultrasonography-guided access. Trial Registration: ClinicalTrials.gov Identifier: NCT03537118.

Initiating and integrating a personalized end of life care project in a community hospital intensive care unit: A qualitative study of clinician and implementation team perspectives.

RATIONALE: The end of life (EOL) experience in the intensive care unit (ICU) can be psychologically distressing for patients, families, and clinicians. The 3 Wishes Project (3WP) personalizes the EOL experience by carrying out wishes for dying patients and their families. While the 3WP has been integrated in academic, tertiary care ICUs, implementing this project in a community ICU has yet to be described. OBJECTIVES: To examine facilitators of, and barriers to, implementing the 3WP in a community ICU from the clinician and implementation team perspective. METHODS: This qualitative descriptive study evaluated the implementation of the 3WP in a 20-bed community ICU in Southern Ontario, Canada. Patients were considered for the 3WP if they had a high likelihood of imminent death or planned withdrawal of life-sustaining therapy. Following the qualitative descriptive approach, semi-structured interviews were conducted with purposively sampled clinicians and implementation team. Data from transcribed interviews were analyzed in triplicate through qualitative content analysis. RESULTS: Interviews with 12 participants indicated that the 3WP personalized and enriched the EOL experience. Interviewees indicated higher intensity education strategies were needed to enable spread as the project grew. Clinicians described many physical resources for the project but suggested more non-clinical project support for orientation, continuing education, and data collection. A majority of wishes focused on physical resources including keepsakes, which helped facilitate project spread when clinician capacity was attenuated by competing duties. CONCLUSIONS: In this community hospital, ICU clinicians and implementation team members report perceived improved EOL care for patients, families, and clinicians following 3WP initiation and integration. Implementing individualized and meaningful wishes at EOL for dying patients in a community ICU requires adequate planning and time dedicated to optimizing clinician education. Adapting key features of an intervention to local expertise and capacity may facilitate spread during project initiation and integration.

Impact of a nurse engagement intervention on pain, agitation and delirium assessment in a community intensive care unit.

BACKGROUND: In 2013, the Society of Critical Care Medicine published a revised version of the ICU Pain, Agitation, and Delirium (PAD) guidelines. Immobility and sleep were subsequently added in 2018. Despite the well-established advantages of implementing these guidelines, adoption and adherence remain suboptimal. This is especially true in community settings, where PAD assessment is performed less often, and the implementation of PAD guidelines has not yet been studied. The purpose of this prospective interventional study is to evaluate the effect of a multifaceted nurse engagement intervention on PAD assessment in a community intensive care unit (ICU). METHODS: All patients admitted to our community ICU for over 24 hours were included. A 20-week baseline audit was performed, followed by the intervention, and a 20-week postintervention audit. The intervention consisted of a survey, focus groups and education sessions. Primary outcomes included rates of daily PAD assessment using validated tools. RESULTS: There were improvements in the number of patients with at least one assessment per day of pain (67.5% vs 59.3%, p=0.04), agitation (93.1% vs 78.7%, p<0.001) and delirium (54.2% vs 39.4%, p<0.001), and the number of patients with target Richmond Agitation-Sedation Scale ordered (63.1% vs 46.8%, p=0.002). There was a decrease in the rate of physical restraint use (10.0% vs 30.9%, p<0.001) and no change in self-extubation rate (0.9% vs 2.5%, p=0.2). CONCLUSION: The implementation of a multifaceted nurse engagement intervention has the potential to improve rates of PAD assessment in community ICUs. Screening rates in our ICU remain suboptimal despite these improvements. We plan to implement multidisciplinary interventions targeting physicians, nurses and families to close the observed care gap.

Qualitative descriptive study to explore nurses' perceptions and experience on pain, agitation and delirium management in a community intensive care unit.

OBJECTIVES: The purpose of this study was to explore the experiences, beliefs and perceptions of intensive care unit (ICU) nurses on the management of pain, agitation and delirium (PAD) in critically ill patients. DESIGN: A qualitative descriptive study. SETTING: This study took place in a community hospital ICU located in a medium size Canadian city. PARTICIPANTS: Purposeful sampling was conducted. Participants included full-time nurses working in the ICU. Forty-six ICU nurses participated. METHODS: A total of five focus group sessions were held to collect data. There were one to three separate groups in each focus group session, with no more than seven participants in each group. There were 10 separate groups in total. A semistructured question guide was used. Thematic analysis method was adopted to analyse the data, and to search for emergent themes and patterns. RESULTS: Three main themes emerged: (1) the professional perspectives on patient wakefulness state, (2) the professional perspectives on PAD management of critically ill patients and (3) the factors impacting PAD management. Nurses have different opinions on the optimal level of patient sedation and felt that many factors, including environmental, healthcare teams, patients and family members, can influence PAD management. This potentially leads to inconsistent PAD management in critically ill patients. The nurses also believed that PAD management requires a multidisciplinary approach including healthcare teams and patients' families. CONCLUSIONS: Many external and internal factors contribute to the complexity of PAD management including the attitudes of nursing staff towards PAD. The themes emerged from this study suggested the need of a multifaceted and multidisciplinary quality improvement programme to optimise the management of PAD in the ICU.

Pain, agitation and delirium assessment and management in a community medical-surgical ICU: results from a prospective observational study and nurse survey.

BACKGROUND: Delirium is a common manifestation in the intensive care unit (ICU) that is associated with increased mortality and morbidity. Guidelines suggested appropriate management of pain, agitation and delirium (PAD) is crucial in improving patient outcomes. However, the practice of PAD assessment and management in community hospitals is unclear and the mechanisms contributing to the potential care gap are unknown. OBJECTIVES: This quality improvement initiative aimed to review the practice of PAD assessment and management in a community medical-surgical ICU (MSICU) and to explore the community MSICU nurses' perceived comfort and satisfaction with PAD management in order to understand the mechanisms of the observed care gap and to inform subsequent quality improvement interventions. METHODS: We prospectively collected basic demographic data, clinical information and daily data on PAD process measures including PAD assessment and target Richmond Agitation-Sedation Scale (RASS) score ordered by intensivists on all patients admitted to a community MSICU for >24 hours over a 20-week period. All ICU nurses in the same community MSICU were invited to participate in an anonymous survey. RESULTS: We collected data on a total of 1101 patient-days (PD). 653 PD (59%), 861 PD (78%) and 439 PD (39%) had PAD assessment performed, respectively. Target RASS was ordered by the intensivists on 515 PD (47%). Our nurse survey revealed that 88%, 85% and 41% of nurses were comfortable with PAD assessment, respectively. CONCLUSIONS: Delirium assessment was not routinely performed. This is partly explained by the discomfort nurses felt towards conducting delirium assessment. Our results suggested that improvement in nurse comfort with delirium assessment and management is needed in the community MSICU setting.