Postoperative Complications and Mobilization Following Major Abdominal Surgery With Versus Without Fitness Tracker-based Feedback (EXPELLIARMUS): A Student-led Multicenter Randomized Controlled Clinical Trial of the CHIR-Net SIGMA Study Group.

OBJECTIVE: To determine whether daily postoperative step goals and feedback through a fitness tracker (FT) reduce the rate of postoperative complications after surgery. BACKGROUND: Early and enhanced postoperative mobilization has been advocated to reduce postoperative complications, but it is unknown whether FT alone can reduce morbidity. METHODS: EXPELLIARMUS was performed at 11 University Hospitals across Germany by the student-led clinical trial network SIGMA. Patients undergoing major abdominal surgery were enrolled, equipped with an FT, and randomly assigned to the experimental (visible screen) or control intervention (blackened screen). The experimental group received daily step goals and feedback through the FT. The primary end point was postoperative morbidity within 30 days using the Comprehensive Complication Index (CCI). All trial visits were performed by medical students in the hospital with the opportunity to consult a surgeon-facilitator who also obtained informed consent. After discharge, medical students performed the 30-day postoperative visit through telephone and electronic questionnaires. RESULTS: A total of 347 patients were enrolled. Baseline characteristics were comparable between the 2 groups. The mean age of patients was 58 years, and 71% underwent surgery for malignant disease, with the most frequent indications being pancreatic, colorectal, and hepatobiliary malignancies. Roughly one-third of patients underwent laparoscopic surgery. No imputation for the primary end point was necessary as data completeness was 100%. There was no significant difference in the CCI between the 2 groups in the intention-to-treat analysis (mean±SD CCI experimental group: 23±24 vs. control: 22±22; 95% CI: -6.1, 3.7; P=0.628). All secondary outcomes, including quality of recovery, 6-minute walking test, length of hospital stay, and step count until postoperative day 7 were comparable between the 2 groups. CONCLUSIONS: Daily step goals combined with FT-based feedback had no effect on postoperative morbidity. The EXPELLIARMUS shows that medical students can successfully conduct randomized controlled trials in surgery.

First initiation of mobilization out of bed after cardiac surgery - an observational cross-sectional study in Sweden.

BACKGROUND: Cardiac surgery is associated with a period of postoperative bed rest. Although early mobilization is a vital component of postoperative care, for preventing complications and enhancing physical recovery, there is limited data on routine practices and optimal strategies for early mobilization after cardiac surgery. The aim of the study was to define the timing for the first initiation of out of bed mobilization after cardiac surgery and to describe the type of mobilization performed. METHODS: In this observational study, the first mobilization out of bed was studied in a subset of adult cardiac surgery patients (n = 290) from five of the eight university hospitals performing cardiothoracic surgery in Sweden. Over a five-week period, patients were evaluated for mobilization routines within the initial 24 h after cardiac surgery. Data on the timing of the first mobilization after the end of surgery, as well as the duration and type of mobilization, were documented. Additionally, information on patient characteristics, anesthesia, and surgery was collected. RESULTS: A total of 277 patients (96%) were mobilized out of bed within the first 24 h, and 39% of these patients were mobilized within 6 h after surgery. The time to first mobilization after the end of surgery was 8.7 ± 5.5 h; median of 7.1 [4.5-13.1] hours, with no significant differences between coronary artery bypass grafting, valve surgery, aortic surgery or other procedures (p = 0.156). First mobilization session lasted 20 ± 41 min with median of 10 [1-11]. Various kinds of first-time mobilization, including sitting on the edge of the bed, standing, and sitting in a chair, were revealed. A moderate association was found between longer intubation time and later first mobilization (ρ = 0.487, p < 0.001). Additionally, there was a moderate correlation between the first timing of mobilization duration of the first mobilization session (ρ = 0.315, p < 0.001). CONCLUSIONS: This study demonstrates a median time to first mobilization out of bed of 7 h after cardiac surgery. A moderate correlation was observed between earlier timing of mobilization and shorter duration of the mobilization session. Future research should explore reasons for delayed mobilization and investigate whether earlier mobilization correlates with clinical benefits. TRIAL REGISTRATION: FoU in VGR (Id 275,357) and Clinical Trials (NCT04729634).

Association between delayed ambulation and increased risk of adverse events after lumbar fusion surgery in elderly patients.

PURPOSE: The relationship between delayed ambulation (DA) and postoperative adverse events (AEs) following transforaminal lumbar interbody fusion (TLIF) in elderly patients remains elusive. The aim of our study was to evaluate the effects of DA on the postoperative AEs including complications, readmission and prolonged length of hospital stay (LOS). METHODS: This was a retrospective analysis of a prospectively established database of elderly patients (aged 65 years and older) who underwent TLIF surgery. The early ambulation (EA) group was defined as patients ambulated within 48 h after surgery, whereas the delayed ambulation (DA) group was patients ambulated at a minimum of 48 h postoperatively. The DA patients were 1:1 propensity-score matched to the EA patients based on age, gender and the number of fused segments. Univariate analysis was used to compare postoperative outcomes between the two groups, and multivariate logistic regression analysis was used to identify risk factors for adverse events and DA. RESULTS: After excluding 125 patients for various reasons, 1025 patients (≤ 48 h: N = 659 and > 48 h: N = 366) were included in the final analysis. After propensity score matching, there were 326 matched patients in each group. There were no significant differences in the baseline data and the surgery-related variables between the two groups (p > 0.05). The patients in the DA group had a significant higher incidence of postoperative AEs (46.0% vs. 34.0%, p = 0.002) and longer LOS (p = 0.001). Multivariate logistic regression identified that age, operative time, diabetes, and DA were independently associated with postoperative AEs, whereas greater age, higher international normalized ratio, and intraoperative estimated blood loss were identified as independent risk factors for DA. CONCLUSIONS: Delayed ambulation was an independent risk factor for postoperative AEs after TLIF in elderly patients. Older age, increased intraoperative blood loss and worse coagulation function were associated with delayed ambulation.

The Interval Between External Ventricular Drain (EVD) Implantation and Time to Mobilization in Patients at the Neurosurgery ICU.

AIM: To describe the time between external ventricular drain (EVD) implantation and mobilization in neurosurgery intensive care unit (ICU) patients with EVDs. Due to increased intracranial pressure, neurosurgery patients with external ventricular drain (EVD) who are admitted to the ICU frequently remain at rest, resulting in prolonged ICU and hospital length of stay (LOS), mechanical ventilator (MV) duration, and other adverse effects. MATERIAL AND METHODS: A retrospective descriptive study was conducted on 131 neurosurgery patients admitted to the ICU with subarachnoid hemorrhage (SAH) or intracerebral hemorrhage (ICH) who underwent EVD. Time of mobilization, level of mobilization, ICU and hospital LOS, MV duration, and other factors were evaluated for patients who met the inclusion criteria. RESULTS: Of the 131 patients, 67 survived, and 61 began to mobilize in varying degrees of dangling (26.22%), standing (44.26%), and walking (29.5%). The mean number of days between EVD implantation and mobilization was 10.15. According to the findings, the mean ICU-LOS in patients was 14.56 days, the MV duration was 7.13 days, the time of ICU discharge from EVD removal was 7.08 days, and the hospital-LOS was 16.98 days. In addition, seven patients (10.44%) developed DVT, and three developed PE (4.47%). CONCLUSION: Prolonged immobility in patients with EVD is associated with negative outcomes such as PE and DVT, as well as an increase in MV duration, ICU-LOS, and hospital-LOS. Therefore, designing an appropriate and standard mobilization protocol and training nursing staff to assist patients in safely mobilizing can significantly reduce the complications above, reduce postoperative care, and empower patients.

The Impact of Epidural Analgesia on Immobility and extended Hospital Stay After Periacetabular Osteotomy.

AIMS: Early mobilisation after periacetabular osteotomy (PAO) represents an important goal after surgery. The purpose of this study was to determine whether the use of epidural aznalgesia (EA) is associated with prolonged immobility and an increased length of stay (LOS) after PAO surgery. METHODS: From January 2022 to July 2023, the study included a cohort of 150 PAO procedures all performed by the same surgeon (SSA). Patients were categorized into two distinct groups: those who received epidural analgesia (EA) (79 PAOs) and those who did not receive EA (71 PAOs). "Ready for discharge" was defined as the ability to ascend and descend a standardized flight of stairs independently. Multivariable linear regression was used to identify additional factors influencing LOS after PAO. RESULTS: Patients in the EA group were ready for discharge 5.95 ± 2.09 days after surgery which was significantly longer than in the No EA group´s average of 4.18 days ± 2.5, (p < 0.001). While the reduction in the number of patients experiencing pulmonary embolism in the No EA group did not reach statistical significance, it still demonstrated a relevant decrease from two patients within the EA group (2.53%) to 0 (0%) in the No EA group. The active engagement of the surgeon in mobilising patients led to a substantial reduction in LOS, decreasing it from 5.81 ± 2.18 days to 2.2 ± 0.77 days (p < 0.001). Multivariable analysis revealed five independent factors influencing the LOS following PAO which included absence of EA, surgeon-led mobilisation within 24 h after surgery, postoperative hemoglobin levels, BMI, and prior experience with PAO surgery on the contralateral side. CONCLUSIONS: Opting against the use of EA in patients undergoing PAO is advisable, as it will result in extended postoperative immobility and the associated risks. Additionally, the active participation of the surgeon in the mobilisation process is strongly recommended.

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.

Comparison of the Outcomes of Enhanced Recovery After Surgery and Traditional Recovery Pathway in Robotic Hysterectomy for Benign Indications: A Randomized Controlled Trial.

STUDY OBJECTIVE: The present study aimed to evaluate the impact of the implementation of the enhanced recovery after surgery (ERAS) program in patients undergoing robotic hysterectomy for benign indications in comparison with conventional management. DESIGN: Randomized controlled trial. SETTING: North Indian tertiary care hospital. PARTICIPANTS: Patients aged 40 to 60 years willing to sign the informed written consent were included, whereas cases with contraindications for neuraxial anesthesia were excluded. A total of 130 subjects undergoing robotic hysterectomy were divided into ERAS (n = 65) and conventional (non-ERAS) (n = 65) groups. INTERVENTIONS: Components of the ERAS protocol included preoperative counseling, carbohydrate loading, early removal of catheter, and early ambulation. Both groups underwent optimization of medical conditions, standardized anesthesia, and venous thromboembolism prophylaxis. MEASUREMENTS AND MAIN RESULTS: Outcome measures included length of hospital stay (LOHS), time to tolerance of diet, postoperative complications, readmission rates, and quality of life assessed by WHO-QOL BREF. Baseline characteristics were comparable between groups. ERAS group showed significantly lower docking time (4.82 ± 0.73 vs 5.31 ± 0.92 minutes), faster tolerance of diet (0.14 ± 0.35 vs 1.14 ± 0.35 days), and earlier resumption of ambulation (0.42 ± 0.5 vs 1.26 ± 0.44 days). Time for "fit for discharge" (1.43 ± 0.61 vs 2.97 ± 1.1 days) and LOHS (2.85 ± 1.09 vs 3.78 ± 1.29 days) were significantly lower in the ERAS group. Postoperative complications and readmission rates were comparable. Quality-of-life scores favored the ERAS group at postoperative days 1 and 30. CONCLUSION: The combination of ERAS and robotic surgery improves patient outcomes, shortens hospital stays, and enhances postoperative recovery without increasing complications. This research serves as a pioneering effort in assessing the impact of ERAS on robotic hysterectomy for benign indications, providing valuable insights for future multicentric studies and supporting the integration of ERAS protocols to enhance patient outcomes and quality of life.

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.

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.

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.

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.

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.

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.

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.

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.