Robotic-Assisted In-Bed Mobilization in Ventilated ICU Patients With COVID-19: An Interventional, Randomized, Controlled Pilot Study (ROBEM II Study).

OBJECTIVES: The COVID-19 pandemic significantly impacted global healthcare systems, particularly in managing critically ill mechanically ventilated patients. This study aims to assess the feasibility of robotic-assisted mobilization in COVID-19 patients. DESIGN: Randomized controlled pilot study. SETTING: Four COVID-19 specialized ICUs at Charité-Universitätsmedizin Berlin (March 2021 to February 2022). PATIENTS: Twenty critically ill COVID-19 patients expected to require greater than 24 hours of ventilation. INTERVENTIONS: A 5-day intervention phase with bid robotic-assisted mobilization greater than or equal to 20 minutes and follow-up at day 180, compared with standard care. MEASUREMENTS AND MAIN RESULTS: Intervention sessions were conducted in 98.9% according to protocol, with one session missing due to staff shortage. Primary outcome was the mobilization level measured with the ICU Mobility Scale (IMS) and Surgical ICU Optimal Mobilization Score (SOMS), assessed until day 5 or extubation. Safety events were recorded during mobilization. The median IMS and SOMS were 0 (0-0.16) and 1 (1-1.03) in the intervention group, and 0 (0-0.15) ( p = 0.77) and 0.8 (0.65-1.20) ( p = 0.08) in the standard care group, respectively. Significant secondary outcomes included average number of mobilization sessions (intervention: 8.5 [7.75-10] vs. standard care: 4.5 [3.5-5]; p = 0.001), total mobilization time (intervention: 232.5 min [187.25-266.5 min] vs. standard care: 147.5 min [107.5-167.5 min]; p = 0.011), and healthcare providers per session (intervention: 2 [2-2] vs. standard care: 1 [1-1.4]; p = 0.001) during intervention. Four safety events (hypertension and agitation, n = 2 each) in the intervention group and none in the standard care group were reported. CONCLUSIONS: Robotic-assisted mobilization in mechanically ventilated COVID-19 patients appears to be safe and feasible.

Goal-directed Perioperative Albumin Substitution Versus Standard of Care to Reduce Postoperative Complications: A Randomized Clinical Trial (SuperAdd Trial).

OBJECTIVE: To investigate whether goal-directed albumin substitution during surgery and postanesthesia care to maintain a serum albumin concentration >30 g/L can reduce postoperative complications. BACKGROUND: Hypoalbuminemia is associated with numerous postoperative complications. Since albumin has important physiological functions, substitution of patients with hypoalbuminemia is worth considering. METHODS: We conducted a single-center, randomized, controlled, outcome assessor-blinded clinical trial in adult patients, American Society of Anesthesiologists physical status classification 3 to 4 or undergoing high-risk surgery. Patients, whose serum albumin concentration dropped <30 g/L were randomly assigned to goal-directed albumin substitution maintaining serum concentration >30 g/L or to standard care until discharge from the postanesthesia intermediate care unit. Standard of care allowed albumin substitution in hemodynamic instable patients with serum concentration <20 g/L, only. Primary outcome was the incidence of postoperative complications ≥2 according to the Clavien-Dindo Classification in at least 1 of 9 domains (pulmonary, infectious, cardiovascular, neurological, renal, gastrointestinal, wound, pain, and hematological) until postoperative day 15. RESULTS: Of 2509 included patients, 600 (23.9%) developed serum albumin concentrations <30 g/L. Human albumin 60 g (40-80 g) was substituted to 299 (99.7%) patients in the intervention group and to 54 (18.0%) in the standard care group. At least 1 postoperative complication classified as Clavien-Dindo Classification ≥2 occurred in 254 of 300 patients (84.7%) in the intervention group and in 262 of 300 (87.3%) in the standard treatment group (risk difference -2.7%, 95% CI, -8.3% to 2.9%). CONCLUSION: Maintaining serum albumin concentration of >30 g/L perioperatively cannot generally be recommended in high-risk noncardiac surgery patients.

Perioperative Hemodynamic Optimization in Patients at Risk for Delirium - A Randomized-Controlled Trial.

Background: Post-operative delirium is common in elderly patients and associated with increased morbidity and mortality. We evaluated in this pilot study whether a perioperative goal-directed hemodynamic optimization algorithm improves cerebral oxygenation and can reduce the incidence of delirium. Materials and Methods: Patients older than 70 years with high risk for post-operative delirium undergoing elective non-cardiac surgery were randomized to an intervention or control group. Patients in the intervention group received a perioperative hemodynamic optimization protocol based on uncalibrated pulse-contour analysis. Patients in the control group were managed according to usual standard of care. Incidence of delirium until day seven was assessed with confusion assessment method (CAM) and chart review. Cerebral oxygenation was measured with near-infrared spectroscopy. Results: Delirium was present in 13 of 85 (15%) patients in the intervention group and 18 of 87 (21%) in the control group [risk difference -5.4%; 95% confidence interval, -16.8 to 6.1%; P = 0.47]. Intervention did not influence length of stay in hospital or in-hospital mortality. Amounts of fluids and vasopressors applied, mean arterial pressure, cardiac index, and near-infrared spectroscopy values were comparable between groups. Conclusion: The hemodynamic algorithm applied in high-risk non-cardiac surgery patients did not change hemodynamic interventions, did not improve patient hemodynamics, and failed to increase cerebral oxygenation. An effect on the incidence of post-operative delirium could not be observed. Clinical Trial Registration: [Clinicaltrials.gov], identifier [NCT01827501].

Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial.

BACKGROUND: Hypalbuminemia is associated with numerous postoperative complications, so a perioperative albumin substitution is often considered. The objective of SuperAdd is to investigate whether substitution of human albumin, aiming to maintain a serum concentration > 30 g/l, can reduce postoperative complications in normovolemic surgical patients in comparison with standard care. METHODS/DESIGN: SuperAdd is a single-center, prospective, randomized, outcome-assessor blinded, patient blinded controlled trial. The primary outcome is the frequency of postoperative complications identified using the Postoperative Morbidity Survey graded ≥ 2 according to the Clavien-Dindo Score. Adult patients at risk to develop hypalbuminemia, i.e., ASA III or IV or high-risk surgery, are recruited after written informed consent was obtained. The albumin concentration is assessed before the induction of anesthesia and every 3 h until admission to the postanesthesia care unit. If albumin concentrations drop below 30 g/l, patients are randomly allocated to the control or the treatment group. The study intervention is a goal-directed human albumin substitution aimed at a concentration > 30 g/l during surgery and postanesthesia care unit stay. The patients in the control group are treated according to standard clinical care. Postoperative visits are to be performed on days 1, 3, 5, 8, and 15, as well as by telephone 6 months after surgery. DISCUSSION: SuperAdd is the first clinical trial in a surgical population investigating the effect of a goal-directed albumin substitution aiming at a serum level > 30 g/l. The nonrestrictive selection of patients guarantees that the patients without albumin screening will most likely not develop hypalbuminemia, thus ensuring generalizability of the study results. TRIAL REGISTRATION: EudraCT 2016-001313-24. Registered on 5 September 2016. Clinical Trials NCT03167645. Registered on 18 October 2016 and has the Universal Trial Number (UTN) U1111-1181-2625.