Daily compliance of the ABCDEF liberation bundle for patients in the intensive care unit: A retrospective descriptive study / Cumplimiento diario del bundle ABCDEF de liberación de los pacientes de cuidados intensivos: estudio descriptivo retrospectivo.

Introduction: Implementing the ABCDEF bundle has demonstrated improved outcomes in patients with critical illness. This study aims to describe the daily compliance of the ABCDEF bundle in a Chilean intensive care unit. Methods: Retrospective observational study of electronic clinical records of nursing, physiotherapy, and medical professionals who cared for patients over 18 years of age, admitted to an intensive care unit for at least 24 hours, with or without mechanical ventilation. Daily bundle compliance was determined by considering the daily records for each element: Assess pain (element A), both spontaneous awakening trials (element B1) and spontaneous breathing trials (element B2), choice of sedation (element C), delirium assessment (element D), early mobilization (element E), and family engagement (element F). Results: 4165 registered bundle elements were obtained from nursing (47%), physiotherapy (44%), and physicians (7%), including 1134 patient/days (from 133 patients). Elements E and C showed 67 and 40% compliance, while D, A, and B2 showed 24, 14 and 11%, respectively. For B1 and F, 0% compliance was achieved. Compliance was higher in patients without mechanical ventilation for A and E, while it was similar for D. Conclusions: Early mobilization had the highest compliance, while spontaneous awakening trials and family engagement had absolute non-compliance. Future studies should explore the reasons for the different degrees of compliance per bundle element in clinical practice.

Introducción: La implementación del ABCDEF ha demostrado mejores resultados en los pacientes críticos. El objetivo de este trabajo es identificar el cumplimiento del registro diario del ABCDEF en una unidad de cuidados intensivos chilena. Métodos: Estudio observacional retrospectivo de los registros clínicos electrónicos de profesionales de enfermería, kinesiología y medicina que trataron a pacientes mayores de 18 años, hospitalizados en una unidad de cuidados intensivos durante al menos 24 horas, con o sin requerimiento de ventilación mecánica. Se determinó el cumplimiento diario del considerando la presencia del registro en la ficha clínica de cada elemento: evaluación del dolor (elemento A), prueba de interrupción de la sedación (elemento B1) y ventilación espontánea (elemento B2), elección de la sedación (elemento C), evaluación del (elemento D), movilización temprana (elemento E) y empoderamiento de la familia (elemento F). Resultados: Se obtuvieron 4165 elementos del registrados provenientes de enfermería (47%), kinesiología (44%) y medicina (7%), incluyendo 1134 días/paciente (133 pacientes). Los elementos E y C mostraron un cumplimiento del 67 y 40%, mientras que D, A, y B2 mostraron 24, 14 y 11%, respectivamente. Para B1 y F se obtuvo 0% de cumplimiento. El cumplimiento fue mayor en los pacientes sin ventilación mecánica para A y E, mientras que para D fue similar. Conclusiones: La movilización temprana fue el elemento con mayor cumplimiento, mientras que las pruebas de interrupción de sedación y el empoderamiento de la familia tuvieron incumplimiento absoluto. Futuros estudios deberían explorar las razones que expliquen los diferentes grados de cumplimiento por elemento del en la práctica clínica.

Assessing the impact of early progressive mobilization on moderate-to-severe traumatic brain injury: a randomized controlled trial.

INTRODUCTION: Traumatic brain injury (TBI) is a major cause of neurodisability worldwide, with notably high disability rates among moderately severe TBI cases. Extensive previous research emphasizes the critical need for early initiation of rehabilitation interventions for these cases. However, the optimal timing and methodology of early mobilization in TBI remain to be conclusively determined. Therefore, we explored the impact of early progressive mobilization (EPM) protocols on the functional outcomes of ICU-admitted patients with moderate to severe TBI. METHODS: This randomized controlled trial was conducted at a trauma ICU of a medical center; 65 patients were randomly assigned to either the EPM group or the early progressive upright positioning (EPUP) group. The EPM group received early out-of-bed mobilization therapy within seven days after injury, while the EPUP group underwent early in-bed upright position rehabilitation. The primary outcome was the Perme ICU Mobility Score and secondary outcomes included Functional Independence Measure motor domain (FIM-motor) score, phase angle (PhA), skeletal muscle index (SMI), the length of stay in the intensive care unit (ICU), and duration of ventilation. RESULTS: Among 65 randomized patients, 33 were assigned to EPM and 32 to EPUP group. The EPM group significantly outperformed the EPUP group in the Perme ICU Mobility and FIM-motor scores, with a notably shorter ICU stay by 5.9 days (p < 0.001) and ventilation duration by 6.7 days (p = 0.001). However, no significant differences were observed in PhAs. CONCLUSION: The early progressive out-of-bed mobilization protocol can enhance mobility and functional outcomes and shorten ICU stay and ventilation duration of patients with moderate-to-severe TBI. Our study's results support further investigation of EPM through larger, randomized clinical trials. Clinical trial registration ClinicalTrials.gov NCT04810273 . Registered 13 March 2021.

Physical Rehabilitation and Mobilization in Patients Receiving Extracorporeal Life Support: A Systematic Review.

OBJECTIVES: We planned to synthesize evidence examining the potential efficacy and safety of performing physical rehabilitation and/or mobilization (PR&M) in adult patients receiving extracorporeal life support (ECLS). DATA SOURCES: We included any study that compared PR&M to no PR&M or among different PR&M strategies in adult patients receiving any ECLS for any indication and any cannulation. We searched seven electronic databases with no language limitations. STUDY SELECTION AND DATA EXTRACTION: Two reviewers, independently and in duplicate, screened all citations for eligibility. We used the Cochrane Risk of Bias 2 and Cochrane Risk Of Bias In Non-randomized Studies of Interventions tools to assess individual study risk of bias. Although we had planned for meta-analysis, this was not possible due to insufficient data, so we used narrative and tabular data summaries for presenting results. We assessed the overall certainty of the evidence for each outcome using the Grading of Recommendations Assessment, Development, and Evaluation framework. DATA SYNTHESIS: We included 17 studies that enrolled 996 patients. Most studies examined venovenous extracorporeal membrane oxygenation (ECMO) and/or venoarterial ECMO as a bridge to recovery in the ICU. We found an uncertain effect of high-intensity/active PR&M on mortality, duration of mechanical ventilation, ICU length of stay, hospital length of stay, or quality of life compared with low-intensity/passive PR&M in patients receiving ECLS (very low certainty due to very serious imprecision). There was similarly an uncertain effect on safety events including clinically important bleeding, spontaneous intracerebral hemorrhage, limb ischemia, accidental decannulation, or ECLS circuit dysfunction (very low certainty due to very serious risk of bias and imprecision). CONCLUSIONS: Based on the currently available summary of evidence, there is an uncertain effect of high-intensity/active PR&M on patient important outcomes or safety in patients receiving ECLS. Despite indirect data from other populations suggesting potential benefit of high-intensity PR&M in the ICU; further high-quality randomized trials evaluating the benefits and risks of physical therapy and/or mobilization in this population are needed.

Safety and feasibility of early mobilization in patients submitted to cardiac surgery using subxiphoid drain.

INTRODUCTION: Patients submitted to heart surgery are restricted to the bed of the Intensive Care Units (ICUs), due to this period of immobility the individual is likely to present clinical and functional alterations. These complications can be avoided by early mobilization; however, in some hospitals, this is not feasible due to the use of subxiphoid drain in the immediate postoperative period. OBJECTIVE: To verify the safety and feasibility of mobilizing patients after cardiac surgery using subxiphoid drain. METHODS: This was a prospective cohort study. On the first day the patient was positioned in sedestration in bed, then transferred from sitting to orthostasis, gait training and sedestration in an armchair. On the second postoperative day the same activities were performed, but with walking through the ICU with a progressive increase in distance. At all these moments, the patient was using the subxiphoid and intercostal drain. The patients were seen three times a day, but physical rehabilitation was performed twice. The adverse events considered were drain obstruction, accidental removal or displacement, total atrioventricular block, postoperative low output syndrome, cardiorespiratory arrest, pneumomediastinum, infection, and pericardial or myocardial damage. RESULTS: 176 patients were evaluated. Only 2 (0.4 %) of the patients had complications during or after mobilization, 1 (0.2 %) due to drain obstruction and 1 (0.2 %) due to accidental removal or displacement. CONCLUSION: Based on the data observed in the results, we found that the application of early mobilization in patients using subxiphoid drain after cardiac surgery is a safe and feasible conduct.

Safety and practicality study of using an exoskeleton in acute neurosurgery patients.

INTRODUCTION: Early mobilization is key in neurologically impaired persons, limiting complications and improving long-term recovery. Self-balanced exoskeletons are used in rehabilitation departments to help patients stand and walk. We report the first case series of exoskeleton use in acute neurosurgery and intensive care patients, evaluating safety, clinical feasibility and patients' satisfaction. METHODS: We report a retrospective observational study including individuals hospitalized in the neurosurgical intensive care and neurosurgery departments. We included patients with a medical prescription for an exoskeleton session, and who met no contraindication. Patients benefited from standing sessions using a self-balanced exoskeleton (Atalante, Wandercraft, France). Patients and sessions data were collected. Safety, feasibility and adherence were evaluated. RESULTS: Seventeen patients were scheduled for 70 standing sessions, of which 27 (39%) were completed. They were typically hospitalized for intracranial hemorrhage (74%) and presented with unilateral motor impairments, able to stand but with very insufficient weight shifting to the hemiplegic limb, requiring support (MRC 36.2 ± 3.70, SPB 2.0 ± 1.3, SPD 0.7 ± 0.5). The average duration of standing sessions was 16 ± 9 min. The only side effect was orthostatic hypotension (18.5%), which resolved with returning to seating position. The most frequent reason for not completing a session was understaffing (75%). All patients were satisfied and expressed a desire to repeat it. CONCLUSIONS: Physiotherapy using the exoskeleton is safe and feasible in the acute neurosurgery setting, although it requires adaptation from the staff to organize the sessions. An efficacy study is ongoing to evaluate the benefits for the patients.

Effects of robotic-assisted early mobilization versus conventional mobilization in intensive care unit patients: prospective interventional cohort study with retrospective control group analysis.

BACKGROUND: Approximately one in three survivors of critical illness suffers from intensive-care-unit-acquired weakness, which increases mortality and impairs quality of life. By counteracting immobilization, a known risk factor, active mobilization may mitigate its negative effects on patients. In this single-center trial, the effect of robotic-assisted early mobilization in the intensive care unit (ICU) on patients' outcomes was investigated. METHODS: We enrolled 16 adults scheduled for lung transplantation to receive 20 min of robotic-assisted mobilization and verticalization twice daily during their first week in the ICU (intervention group: IG). A control group (CG) of 13 conventionally mobilized patients after lung transplantation was recruited retrospectively. Outcome measures included the duration of mechanical ventilation, length of ICU stay, muscle parameters evaluated by ultrasound, and quality of life after three months. RESULTS: During the first week in the ICU, the intervention group received a median of 6 (interquartile range 3-8) robotic-assisted sessions of early mobilization and verticalization. There were no statistically significant differences in the duration of mechanical ventilation (IG: median 126 vs. CG: 78 h), length of ICU stay, muscle parameters evaluated by ultrasound, and quality of life after three months between the IG and CG. CONCLUSION: In this study, robotic-assisted mobilization was successfully implemented in the ICU setting. No significant differences in patients' outcomes were observed between conventional and robotic-assisted mobilization. However, randomized and larger studies are necessary to validate the adequacy of robotic mobilization in other cohorts. TRIAL REGISTRATION: This single-center interventional trial was registered in clinicaltrials.gov as NCT05071248 on 27/08/2021.

Smartfeeding: A Dynamic Strategy to Increase Nutritional Efficiency in Critically Ill Patients-Positioning Document of the Metabolism and Nutrition Working Group and the Early Mobilization Working Group of the Catalan Society of Intensive and Critical Care Medicine (SOCMiC).

Adequate medical nutrition therapy for critically ill patients has an impact on their prognoses. However, it requires an individualized approach that takes into account the activity (phases of metabolic stress) and particularity of these patients. We propose a comprehensive strategy considering the patients' nutritional status and the set of modifiable circumstances in these patients, in order to optimize/support nutritional efficiency: (1) A detailed anamnesis and an adequate initial nutritional assessment must be performed in order to implement medical nutrition therapy that is in line with the needs and characteristics of each patient. Furthermore, risks associated with refeeding syndrome, nutritrauma or gastrointestinal dysfunction must be considered and prevented. (2) A safe transition between nutrition therapy routes and between health care units will greatly contribute to recovery. The main objective is to preserve lean mass in critically ill patients, considering metabolic factors, adequate protein intake and muscle stimulation. (3) Continuous monitoring is required for the successful implementation of any health strategy. We lack precise tools for calculating nutritional efficiency in critically ill patients, therefore thorough monitoring of the process is essential. (4) The medical nutrition approach in critically ill patients is multidisciplinary and requires the participation of the entire team involved. A comprehensive strategy such as this can make a significant difference in the functional recovery of critically ill patients, but leaders must be identified to promote training, evaluation, analysis and feedback as essential components of its implementation, and to coordinate this process with the recognition of hospital management.

Application of quality control circle in the management of early ambulation after cesarean section: An observational study.

BACKGROUND: The quality control circle (QCC) model has achieved good results in clinical applications in many hospitals in China and has gained popularity. This study aims to explore the application of QCC activities on early ambulation after cesarean section. METHODS: A QCC management group was established following standardized methods and techniques. The theme of the group was identified as "to enhance the implementation rate of the patient early ambulation after the cesarean section" through a matrix graph. The early ambulation rates after surgery of patients who received cesarean section were compared before and after QCC managements. RESULTS: Our data suggested that the early ambulation rates after cesarean section increased from 37.5% to 81.25% after applying QCC management. The biggest factor influencing the ambulation activities 24 ±â€…4 hours after the surgery was patients and family members do not cooperate. In addition, outstanding improvements in terms of nurses' sense of responsibility and self-confidence, communication and teamwork capacity in the problem-solving process were observed after the establishment of QCC. CONCLUSION: The application of QCC management had not only increase the early ambulation rates after cesarean section but also improved the quality of nursery care in general.

Early Mobility Index and Patient Outcomes: A Retrospective Study in Multiple Intensive Care Units.

BACKGROUND: Early mobility interventions in intensive care units (ICUs) are safe and improve outcomes in subsets of critically ill adults. However, implementation varies, and the optimal mobility dose remains unclear. OBJECTIVE: To test for associations between daily dose of out-of-bed mobility and patient outcomes in different ICUs. METHODS: In this retrospective cohort study of electronic records from 7 adult ICUs in an academic quarternary hospital, multivariable linear regression was used to examine the effects of out-of-bed events per mobility-eligible day on mechanical ventilation duration and length of ICU and hospital stays. RESULTS: In total, 8609 adults hospitalized in ICUs from 2015 through 2018 were included. Patients were mobilized out of bed on 46.5% of ICU days and were eligible for mobility interventions on a median (IQR) of 2.0 (1-3) of 2.7 (2-9) ICU days. Median (IQR) out-of-bed events per mobility-eligible day were 0.5 (0-1.2) among all patients. For every unit increase in out-of-bed events per mobility-eligible day before extubation, mechanical ventilation duration decreased by 10% (adjusted coefficient [95% CI], -0.10 [-0.18 to -0.01]). Daily mobility increased ICU stays by 4% (adjusted coefficient [95% CI], 0.04 [0.03-0.06]) and decreased hospital stays by 5% (adjusted coefficient [95% CI], -0.05 [-0.07 to -0.03]). Effect sizes differed among ICUs. CONCLUSIONS: More daily out-of-bed mobility for ICU patients was associated with shorter mechanical ventilation duration and hospital stays, suggesting a dose-response relationship between daily mobility and patient outcomes. However, relationships differed across ICU subpopulations.

Barriers and facilitators to early mobilisation and weight-bearing as tolerated after hip fracture surgery among older adults in Saudi Arabia: a qualitative study.

OBJECTIVE: To explore the practice of prescribing and implementing early mobilisation and weight-bearing as tolerated after hip fracture surgery in older adults and identify barriers and facilitators to their implementation. METHODS: Semi-structured interviews were conducted with 20 healthcare providers (10 orthopaedic surgeons and 10 physiotherapists) from Saudi Arabian government hospitals. Data were analysed using inductive thematic analysis. RESULTS: While early mobilisation and weight-bearing as tolerated were viewed as important by most participants, they highlighted barriers to the implementation of these practices. Most participants advocated for mobility within 48 h of surgery, aligning with international guidance; however, the implementation of weight-bearing as tolerated was varied. Some participants stressed the type of surgery undertaken as a key factor in weight-bearing prescription. For others, local protocols or clinician preference was seen as most important, the latter partially influenced by where they were trained. Interdisciplinary collaboration between orthopaedic surgeons and physiotherapists was seen as a crucial part of postoperative care and weight-bearing. Patient and family member buy-in was also noted as a key factor, as fear of further injury can impact a patient's adherence to weight-bearing prescriptions. Participants noted a lack of standardised postoperative protocols and the need for routine patient audits to better understand current practices and outcomes. CONCLUSION: This study contributes to national and global discussions on the prescription of early mobilisation and weight-bearing as tolerated. It highlights the necessity for a harmonised approach, incorporating standardised, evidence-based protocols with patient-specific care, robust healthcare governance and routine audits and monitoring for quality assurance and better patient outcomes.

Fatigue, fear of being mobilized and residual limb pain limit independent basic mobility and physiotherapy for patients early after major dysvascular lower extremity amputation: A prospective cohort study.

AIM: Early mobilization of patients with a major lower extremity amputation (LEA) is often a challenge because of lack of compliance. Therefore, we investigated factors limiting independent mobility and physiotherapy on the first day with physiotherapy (PTDay1) and the following 2 days after LEA. METHODS: A total of 60 consecutive patients, mean age 73.7 years (SD 12.1 years), undergoing LEA were included over a period of 7 months. The Basic Amputee Mobility Score was used to assess basic mobility. Predefined limitations for not achieving independent mobility or not completing physiotherapy were residual limb pain, pain elsewhere, fear of being mobilized, fatigue, nausea/vomiting, acute cognitive dysfunction or "other" factors reported on PTDay1 and the following 2 days after LEA. RESULTS: Fatigue and fear of being mobilized were the most frequent limitations for not achieving independent mobility on PTDay1 and the following 2 days after LEA. Patients (n = 55) who were not independent in the Basic Amputee Mobility Score activity transferring from bed to chair on PTDay1 were limited by fatigue (44%) and fear of being mobilized (33%). A total of 21 patients did not complete planned physiotherapy on PTDay1, and were limited by fatigue (38%), residual limb pain (24%) and "other" factors (24%). CONCLUSION: Fatigue and fear of being mobilized were the most frequent factors that limited independent mobility early after LEA. Fatigue, residual limb pain and "other" factors limited completion of physiotherapy. Geriatr Gerontol Int 2024; 24: 470-476.

Resultado da mobilização precoce sobre as repercussões clínicas e funcionais de cirurgias torácicas: revisão integrativa / Resultados de la temprana movilización sobre las repercusiones clínicas y funcionales de cirugíatorácica: revisión integrativa / Results of early mobilization on the clinical and functional repercussions of patients submitted to thoracic surgery: integrative review

Introdução: O período de internação os pacientes passam por um longo período de imobilização no leito, acompanhada de complicações e comorbidades que podem ocorrer no período pós-operatório. A fisioterapia aturará prevenindo os efeitos da imobilidade no leito, além de melhorar a independência funcional do paciente. Objetivo: Diante o exposto, o objetivo desse estudo é analisar as repercussões clínicas e funcionais da reabilitação precoce em pacientes submetidos à cirurgia torácica. Metodologia: Trata-se de uma revisão integrativa. Critérios de inclusão: ensaios clínicos randomizados, artigos completos, dos idiomas português, inglês e espanhol, publicados entre 2012 e 2022. Critérios de exclusão: protocolos de ensaios, ensaios não finalizados, estudos inferiores ao ano de 2012 e outras línguas. Descritores: Cirurgia torácica; Deambulação precoce; Modalidades de Fisioterapia. Com seus respectivos termos na língua inglesa. Resultados: Foram encontrados 51 artigos. Com os critérios estabelecidos foram selecionados 06 artigos. Os estudos dos autores avaliados se mostraram benéficos para a terapia de deambulação precoce combinada e exercícios. Conclusões: Os achados resultam na minimização das alterações de fluxo e volume pulmonar, otimização da mecânica do movimento tóraco-abdominal e aumento da amplitude do movimento dos músculos respiratórios, facilitando a reexpansão pulmonar e melhorando osparâmetros de função pulmonar (AU)>

Introduction: During hospitalization, patients go through a long period of immobilization in bed, accompanied by complications and comorbidities that may occur in the postoperative period. Physical therapy will help prevent the effects of immobility in bed, in addition to improving the patient's functional independence. Objective:Given the above, the objective of this study is to analyze the clinical and functional repercussions of early rehabilitation in patients undergoing thoracic surgery. Methodology:It is a systematic review. Inclusion criteria: randomized clinical trials, complete articles, in Portuguese, English and Spanish, published between 2012 and 2022. Exclusion criteria: trial protocols, unfinished trials, studies smaller than 2012 in other languages. Descriptors: Thoracic surgery; Early ambulation; Physiotherapy modalities. Results:51 articles were found. With the established criteria, 06 articles were selected. The evaluated authors' studies have shown benefit for combined early ambulation therapy and exercise. Conclusions:The findings result in the minimization of changes in lung flow and volume, optimization of the mechanics of thoracoabdominal movement and increased range of motion of the respiratory muscles, facilitating lung re-expansion and improving lung function parameters (AU).

Introducción: A lo largo de la hospitalización, los pacientes pasan por un largo período de inmovilización en cama, acompañado de complicacionesy comorbilidades que pueden presentarse en el postoperatorio. La fisioterapia ayudará a prevenir los efectos de la inmovilidad en cama, además de mejorar la independencia funcional del paciente. Objetivo:Teniendo en cuenta lo anterior, el objetivo de este estudio es analizar las repercusiones clínicas y funcionales de la rehabilitación temprana en pacientes sometidos a cirugía torácica.Metodología: Esta es una revisión sistemática. Criterios de inclusión: ensayos clínicos aleatorizados, artículos completos, en portugués, inglés y español, publicados entre 2012 y 2022. Criterios de exclusión: protocolos de ensayos, ensayos inconclusos, estudios menores a 2012 y otros idiomas. Descriptores: Cirugía torácica; Deambulación temprana; Modalidades de fisioterapia. Con sus respectivos términosen inglés.Resultados: Se encontraron 51 artículos. Fueron seleccionados 06 artículos, con los criterios establecidos. Los estudios de los autores evaluados han demostrado beneficios para la combinación de terapia de deambulación temprana y ejercicio.Conclusiones: Los hallazgos resultan en la minimización de alteraciones en el flujo y volumen pulmonar, optimización de la mecánica del movimiento toracoabdominal y aumento en el rango de movimiento de los músculos respiratorios, facilitando la reexpansión pulmonar y mejorando los parámetrosde la función pulmonar (AU).

Influence of motivational interviewing on postoperative mobilization in the enhanced recovery after surgery (ERAS®) pathway in elective colorectal surgery - a randomized patient-blinded pilot study.

PURPOSE: Early mobilization is an essential component of the Enhanced Recovery after Surgery (ERAS®)-pathway. However, a large percentage of patients fail to achieve the ERAS® recommended goal (360 min out of bed from post-operative day 1/POD1). Motivational Interviewing (MI) is an evidence-based type of patient-centered consultation to promote intrinsic motivation. This study aims to evaluate if MI can improve postoperative mobilization. METHODS: This two-arm, patient-blinded pilot randomized controlled trial included ERAS®-patients undergoing elective bowel resections. Conversations were validated by MI Treatment Integrity. Two validated motion sensors (movisens) and self-assessments were used to measure mobilization (POD1-POD3: Time out of bed, time on feet and step count). RESULTS: 97 patients were screened, 60 finally included and randomized. Cumulatively across POD1-3, the intervention group (IG) was longer out of bed than the control group (CG) (median: 685 vs. 420 min; p=0.022). The IG achieved the ERAS®-goal of 360 min/day more frequently across POD1-3 (27.4% vs. 10.61%; p=0.013). Time on feet was 131.5 min/day (median per POD) in IG vs. 95.8 min/day in the CG (p=0.212), step count was 1347 in IG vs. 754 steps/day in CG (p=0.298). CONCLUSION: MI could be conducted low threshold and was well accepted by patients. MI can improve mobilization in the context of ERAS®. Despite better performance, it should be noted that only 27.4% of the IG reached the ERAS®-compliance goal of 360 min/day. The findings of this pilot study stipulate to further test the promising perioperative effects of MI within a multicenter superiority trial. REGISTRATION: This study was registered prospectively in the German Clinical Trials Register on 25.02.2022. Trial registration number is "DRKS00027863".

Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

Association of active mobilisation variables with adverse events and mortality in patients requiring mechanical ventilation in the intensive care unit: a systematic review and meta-analysis.

BACKGROUND: Mobilisation during critical illness is now included in multiple clinical practice guidelines. However, a large, randomised trial and systematic review have recently identified an increased probability of adverse events and mortality in patients who received early active mobilisation in the intensive care unit (ICU). We aimed to determine the effects of mobilisation compared with usual care on adverse events and mortality in an acute ICU setting. In subgroup analyses, we specifically aimed to investigate possible sources of harm, including the timing and duration of mobilisation achieved, ventilation status, and admission diagnosis. METHODS: In this systematic review with frequentist and Bayesian analyses, we searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, CINAHL, SPORTDiscus, SCOPUS, Web of Science, and PEDro electronic databases, as well as clinical trial registries (ICTRP and ClinicalTrials.gov), from inception to March 16, 2023, without language restrictions. Eligible studies were randomised controlled trials that examined active mobilisation compared with either no mobilisation or mobilisation commencing later, or at a lower frequency or intensity, in adults who were critically ill during or after a period of mechanical ventilation in an acute ICU setting. Two authors independently screened reports, extracted data, and assessed the risk of bias using the Cochrane risk-of-bias tool (version 1). The primary outcome was the number of adverse events that occurred during the implementation of mobilisation, with the effect of mobilisation on mortality being the secondary outcome. Risk ratios (RRs) with 95% CIs were calculated in R (version 4.0.3) using random-effects modelling, with Bayesian analysis completed to calculate the probability of treatment harm (ie, RR >1). Subgroup analyses were completed to investigate the association of various factors of mobilisation on adverse events and mortality: duration of mobilisation (longer [≥20 min per day] vs shorter [<20 min per day]), timing of commencement (early [≤72 h from ICU admission] vs late [>72 h from ICU admission]), ventilation status at commencement (all patients mechanically ventilated vs all patients extubated), and ICU admission diagnosis (surgical vs medical). This study was registered with PROSPERO, CRD42022369272. FINDINGS: After title and abstract screening of 14 440 studies and review of 466 full texts, 67 trials with 7004 participants met inclusion criteria, with 59 trials contributing to the meta-analysis. Of the 67 included studies, 15 (22%) did not mention adverse events and 13 (19%) reported no adverse events occurring across the trial period. Overall, we found no effect of mobilisation compared with usual care on the occurrence of adverse events (RR 1·09 [95% CI 0·69-1·74], p=0·71; I2 91%; 32 731 events, 20 studies; very low certainty), with a 2·96% occurrence rate (693 events in 23 395 intervention sessions; 25 studies). Mobilisation did not have any effect on mortality (RR 0·98 [95% CI 0·87-1·12], p=0·81; I2 0%; n=6218, 58 studies; moderate certainty). Subgroup analysis was hindered by the large amount of data that could not be allocated and analysed, making the results hypothesis generating only. INTERPRETATION: Implementation of mobilisation in the ICU was associated with a less than 3% chance of an adverse event occurring and was not found to increase adverse events or mortality overall, providing reassurance for clinicians about the safety of performing this intervention. Subgroup analyses did not clearly identify any specific variable of mobilisation implementation that increased harm. FUNDING: None.

The effect of early mobilisation (< 14 days) on pathophysiological and functional outcomes in animals with induced spinal cord injury: a systematic review with meta-analysis.

INTRODUCTION: The optimum time to mobilise (standing, walking) following spinal cord injury (SCI) is unknown but may have implications for patient outcomes. There are no high-quality experimental studies that examine this issue, with a paucity of guidance for clinicians. Pre-clinical studies lead research in this field and can contribute to knowledge and support future clinical practice. OBJECTIVE: to evaluate the effect of early compared to no mobilisation on pathophysiological and functional outcomes in animals with induced SCI. METHODS: A systematic review with meta-analysis was conducted by searching pre-clinical literature in MEDLINE (PubMed), Embase (Ovid), Web of Science, OpenGrey, and EThOS (June 2023). Studies were included of any research method giving numerical results comparing pathophysiological and functional outcomes in rats and mice mobilised within 14-days of induced SCI to those that did not mobilise. Data were synthesised using random-effects meta-analyses. The quality of the evidence was assessed using the CAMARADES checklist. The certainty of findings was reported using the GRADE approach. This study is registered on PROSPERO (CRD42023437494). RESULTS: Seventeen studies met the inclusion criteria. Outcomes found that Brain Derived Neurotrophic Factor levels were greater in those that initiated mobilisation within 14-days of SCI compared to the groups that did not. Mobilisation initiated within 14-days of SCI was also associated with statistically significant functional gains: (Basso, Beattie and Bresnahan locomotor rating score (BBB) = 2.13(0-21), CI 1.43, 2.84, Ladder Rung Walking Task = - 12.38(0-100), CI 20.01, - 4.76). Meta-analysis identified the greatest functional gains when mobilisation was initiated within 3 days of SCI (BBB = 3.00, CI 2.31-3.69, p < 0.001), or when delivered at low intensity (BBB = 2.88, CI 2.03-3.70, p < 0.001). Confidence in the findings from this review was low to moderate due to the risk of bias and mixed methodological quality. CONCLUSION: Mobilisation instigated within 14-days of injury, may be an effective way of improving functional outcomes in animal models following SCI, with delays potentially detrimental to recovery. Outcomes from this study support further research in this field to guide future clinical practice.

Early ambulation protocol after diagnostic transfemoral cerebral angiography: an evidence-based practice project.

BACKGROUND: No uniform consensus has been achieved regarding the ambulation protocol after transfemoral cerebral angiography (TFA). Until now, in most hospitals patients are prescribed 8-12 h strict immobilization along with bed rest in the supine position after TFA in China, which causes great discomfort to patients. OBJECTIVE: To evaluate the effect of an evidence-based early ambulation protocol on the prevention of vascular complications and general discomfort in patients following transfemoral cerebral angiography (TFA). METHODS: A prospective quasi-experimental study was conducted on 214 patients undergoing TFA with manual compression. Patients in the experimental group were placed supine position for 2 h with a sandbag placed on the wound dressing, followed by a semi-seated position for another 2 h. After this period, patients took 2 h bed rest (move freely) with the sandbag removed, and were allowed to get out of bed 6 h after TFA. Patients in the control group were restricted to an 8 h bed rest in a supine position with the affected leg straight and immobilized. The vascular complications (bleeding, hematoma, ecchymosis) and levels of comfort (low back pain, leg pain, and blood pressure) were evaluated after the procedure. Numeric Rating Scale (NRS) pain scores, systolic blood pressure (SBP); diastolic blood pressure (DBP) were measured hourly for 8 h after TFA. RESULTS: There was no significant difference in the two groups with regard to vascular complications including bleeding events (P = 0.621), bleeding volume (P = 0.321), and area of hematoma (P = 0.156). The area of ecchymosis in the experimental group was significantly smaller than the control group (P = 0.031). Compared with the control group, the NRS score for low back pain in the 4th, 5th, 6th, 7th, and 8th hour after TFA were significantly lower (P < 0.05), and the NRS score for leg pain in the 5th, 6th, 7th, 8th hour after TFA were significantly lower (P < 0.05). The SBP and DBP in the 6th, 7th, and 8th hour after TFA were significantly lower than the control group (all P < 0.05). CONCLUSIONS: The evidence-based early ambulation protocol can effectively and safely increase comfort and decrease the pain level for patients undergoing TFA, without change in the incidence of vascular complications.