scholarly journals Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial

Author(s):  
Fabio Accorsi ◽  
Jonathan Chung ◽  
Amol Mujoomdar ◽  
Daniele Wiseman ◽  
Stewart Kribs ◽  
...  

Graphical abstarct Purpose To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique. Methods A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2.7 kg/m2). A propensity score-matched retrospective cohort of 25 patients who received percutaneous radiologic gastrostomy (PRG) was generated as an institutional control (mean age 66 ± 14 years, 92% men, 80% inpatients, mean BMI 24.0 ± 2.7 kg/m2). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE’s). Secondary outcomes included procedural duration, sedation requirements, and hospital length of stay. Results All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG in rates of mild AE’s (3/25 [12%] for PUG and 7/25 [28%] for PRG, p = 0.16) or moderate AE’s (1/25 [4%] for PUG and 0/25 for PRG, p = 0.31). There were no severe AE’s or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5 ± 14.1 min) than PRG (39.3 ± 15.0 min, p < 0.001). PUG procedure time was significantly shorter after a procedural enhancement, the incorporation of a Gauss meter to facilitate successful magnetic gastropexy. Length of stay for outpatients did not significantly differ (2.4 ± 0.5 days for PUG and 2.6 ± 1.0 days for PRG, p = 0.70). Conclusion PUG appears effective with a safety profile similar to PRG. Bedside point-of-care gastrostomy tube insertion using the PUG technique shows promise. Trial Registration Number: ClinicalTrials.gov ID NCT03575754. Graphical abstract

2015 ◽  
Vol 4 (5) ◽  
pp. 1 ◽  
Author(s):  
Erin Powers Kinney ◽  
Kamal Gursahani ◽  
Eric Armbrecht ◽  
Preeti Dalawari

Objective: Previous studies looking at emergency department (ED) crowding and delays of care on outcome measures for certain medical and surgical patients excluded trauma patients. The objectives of this study were to assess the relationship of trauma patients’ ED length of stay (EDLOS) on hospital length of stay (HLOS) and on mortality; and to examine the association of ED and hospital capacity on EDLOS.Methods: This was a retrospective database review of Level 1 and 2 trauma patients at a single site Level 1 Trauma Center in the Midwest over a one year period. Out of a sample of 1,492, there were 1,207 patients in the analysis after exclusions. The main outcome was the difference in hospital mortality by EDLOS group (short was less than 4 hours vs. long, greater than 4 hours). HLOS was compared by EDLOS group, stratified by Trauma Injury Severity Score (TRISS) category (< 0.5, 0.51-0.89, > 0.9) to describe the association between ED and hospital capacity on EDLOS.Results: There was no significant difference in mortality by EDLOS (4.8% short and 4% long, p = .5). There was no significant difference in HLOS between EDLOS, when adjusted for TRISS. ED census did not affect EDLOS (p = .59), however; EDLOS was longer when the percentage of staffed hospital beds available was lower (p < .001).Conclusions: While hospital overcrowding did increase EDLOS, there was no association between EDLOS and mortality or HLOS in leveled trauma patients at this institution.


2020 ◽  
Vol 48 (8) ◽  
pp. 030006052093858
Author(s):  
Rony M. Zeenny ◽  
Hanine Mansour ◽  
Wissam K Kabbara ◽  
Nibal Chamoun ◽  
Myriam Audi ◽  
...  

Objective We evaluated the effect of chronic use of statins based on C-reactive protein (CRP) levels and hospital length of stay (LOS) in patients admitted with community-acquired pneumonia (CAP). Methods We conducted a retrospective study over 12 months at a teaching hospital in Lebanon comparing patients with CAP taking chronic statins with patients not taking statins. Included patients with CAP were older than age 18 years and had two CRP level measures during hospitalization. CURB-65 criteria were used to assess the severity of pneumonia. A decrease in CRP levels on days 1 and 3, LOS, and normalization of fever were used to assess the response to antibiotics. Results Sixty-one patients were taking statins and 90 patients were not taking statins. Patients on statins had significantly more comorbid conditions; both groups had comparable CURB-65 scores. In both groups, no statistically significant difference was seen for the decrease in CRP level on days 1 and 3 and LOS. No difference in days to normalization of fever was detected in either group. Conclusion No association was found between the chronic use of statins and CRP levels, LOS, or days to fever normalization in patients with CAP.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 232-232
Author(s):  
Devika Govind Das ◽  
Courtney Williams ◽  
Kelly Nicole Godby ◽  
Gabrielle Betty Rocque ◽  
Pamela Cargo ◽  
...  

232 Background: Traditionally, hospital units function as multidisciplinary teams which work in silos and communicate via notes in the Electronic Health System. This often leads to communication breakdown, frequently translating to adverse clinical outcomes and prolonged hospital length of stay. Our primary objective was to introduce Inter-Professional Team (IPT) rounds on the oncology unit and evaluate the impact on length of stay (LOS) within a Plan, Do, Study, Act (PDSA) cycle. Methods: The care transition team planned the IPT rounds structure and training curriculum which included team goals, post-rounds structure for addressing barriers to care progression, and member roles/scripting. Change in LOS and case mix index (CMI)-adjusted LOS post-IPT round implementation ( Do) in July 2017 was analyzed ( Study) using hierarchical linear models for patients with an admission to the oncology service from September 2016 to March 2018. Beta coefficients (β) and 95% confidence intervals (CI) were estimated and models were adjusted for calendar time. Results: Ten attending medical oncologists participated in IPT round implementation. Of 889 oncology admissions, median LOS and CMI-adjusted LOS pre-IPT round implementation (n = 464) was 4 days (IQR 2-6) and 3 days (IQR 1.8-4.7), while post-IPT round implementation (n = 425) was 4 days (IQR 2-6) and 2.9 days (IQR 1.9-4.4), respectively. Three common reasons for admission were septicemia (n = 96), hematologic complications (n = 42, e.g. anemia/neutropenia), and renal failure (n = 25). Adjusted models for LOS and CMI-adjusted LOS showed no significant difference post-IPT round implementation (β = 0.8 days, 95% CI -0.7-2.3; β = 0.5 days, 95% CI -0.3-1.3, respectively) when compared to pre-implementation. Conclusions: We did not observe decreased LOS in early outcomes. However, IDT rounds built on TEAMSTEPPS 2.0 elements with incorporation of key principles desirable in a patient care team. Next steps include further analysis to better understand cancer stages and diagnoses contributing to longer LOS. We also plan to evaluate patient satisfaction, educational needs, and readmission rates to restructure ( Act) IPT rounds to better serve the needs of our unique patient population.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 688-688
Author(s):  
Christopher R. Deig ◽  
Blake Beneville ◽  
Amy Liu ◽  
Aasheesh Kanwar ◽  
Alison Grossblatt-Wait ◽  
...  

688 Background: Whether upfront resection or total neoadjuvant therapy is superior for the treatment of potentially resectable pancreatic adenocarcinoma (PDAC) remains controversial. The impact of neoadjuvant treatment on major perioperative complication rates for patients (pts) undergoing resection for PDAC is commonly debated. We hypothesized that rates would be comparable among patients receiving neoadjuvant chemoradiation (neo-CRT), neoadjuvant chemotherapy alone (neo-CHT), or upfront surgery. Methods: This is a retrospective study of 208 pts with PDAC who underwent resection within a multidisciplinary pancreatico-biliary program at an academic tertiary referral center between 2011-2018. Data were abstracted from the medical record, an institutional cancer registry and NSQIP databases. Outcomes were assessed using χ2, Fisher’s exact test and two-tailed Student’s t-tests. Results: 208 pts were identified: 33 locally advanced, borderline or upfront resectable pts underwent neo-CRT, 35 borderline or resectable pts underwent neoadjuvant-CHT, and 140 resectable pts did not undergo neoadjuvant therapy. There were no statistically significant differences in major perioperative complication rates between groups. Overall rates were 36.4%, 34.3%, and 26.4% for pts who underwent neo-CRT, neo-CHT alone, or upfront resection, respectively (p = 0.38). No significant difference were observed in complication rates (35.3% v. 26.4%; p = 0.19) or median hospital length of stay (10 days v. 10 days; p = 0.87) in pts who received any neoadjuvant therapy versus upfront resection. There were two perioperative deaths in the neo-CRT group (6.1%), zero in the neo-CHT group, and four in the upfront resection group (2.9%); p = 0.22. Conclusions: There were no significant differences in major perioperative complication rates, hospital length of stay, or post-operative mortality in pts who underwent neoadjuvant therapy (neo-CRT or neo-CHT alone) versus upfront surgery. Notably, neo-CRT had comparable perioperative complication rates to neo-CHT alone, which suggests neoadjuvant radiation therapy may not pose additional surgical risk.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mehul V. Raval ◽  
Erin Wymore ◽  
Martha-Conley E. Ingram ◽  
Yao Tian ◽  
Julie K. Johnson ◽  
...  

Abstract Background Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking. The study is designed to evaluate the adoption, effectiveness, and generalizability of a 21-element ERP, adapted for pediatric surgery. Methods The multicenter study is a stepped-wedge, cluster-randomized, pragmatic clinical trial that will evaluate the effectiveness of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention while also assessing site-specific adaptations, implementation fidelity, and sustainability. The target patient population is pediatric patients, between 10 and 18 years old, who undergo elective gastrointestinal surgery. Eighteen (N = 18) participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period (stepped-wedge). Each cluster will participate in a Learning Collaborative, using the National Implementation Research Network’s five Active Implementation Frameworks (AIFs) (competency, organization, and leadership), as drivers of facilitation of rapid-cycle adaptations and implementation. The primary study outcome is hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability. Additional clinical outcomes include opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. Discussion The study provides a unique opportunity to accelerate the adoption of ERPs across 18 US pediatric surgical centers and to evaluate, for the first time, the effect of a pediatric-specific ENRICH-US intervention on clinical and implementation outcomes. The study design and methods can serve as a model for future pediatric surgical quality improvement implementation efforts. Trial registration ClinicalTrials.gov NCT04060303. Registered on 07 August 2019.


2018 ◽  
Vol 9 (2) ◽  
pp. 133-137 ◽  
Author(s):  
Luke Brown ◽  
Tristan Weir ◽  
Scott Koenig ◽  
Mark Shasti ◽  
Imran Yousaf ◽  
...  

Study Design: Single-blinded prospective randomized control trial. Objectives: To compare the incidence of adverse events (AEs) and hospital length of stay between patients who received liposomal bupivacaine (LB) versus a single saline injection, following posterior lumbar decompression and fusion surgery for degenerative spondylosis. Methods: From 2015 to 2016, 59 patients undergoing posterior lumbar decompression and fusion surgery were prospectively enrolled and randomized to receive either 60 mL injection of 266 mg LB or 60 mL of 0.9% sterile saline, intraoperatively. Outcome measures included the incidence of postoperative AEs and hospital length of stay. Results: The most common AEs in the treatment group were nausea (39.3%), emesis (18.1%), and hypotension (18.1%). Nausea (23%), constipation (19.2%), and urinary retention (15.3%) were most common in the control group. Patients who received LB had an increased risk of developing nausea (relative risk [RR] = 1.7; 95% confidence interval [CI] = 0.75-3.8), emesis (RR = 2.3; 95% CI = 0.51-10.7), and headaches (RR = 2.36; 95% CI = 0.26-21.4). Patients receiving LB had a decreased risk of developing constipation (RR = 0.78; 95% CI = 0.25-2.43), urinary retention (RR = 0.78; 95% CI = 0.21-2.85), and pruritus (RR = 0.78; 95% = 0.21-2.8) postoperatively. Relative risk values mentioned above failed to reach statistical significance. No significant difference in the hospital length of stay between both groups was found (3.9 vs 3.9 days; P = .92). Conclusion: Single-dose injections of LB to the surgical site prior to wound closure did not significantly increase or decrease the incidence or risk of developing AEs postoperatively. Furthermore, no significant difference was found in the hospital length of stay between both groups.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ximena Cid ◽  
David Canty ◽  
Alistair Royse ◽  
Andrea B. Maier ◽  
Douglas Johnson ◽  
...  

Abstract Background Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity, and mortality. Methods/design A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 h of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan, and two-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax, and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission, and healthcare costs. Discussion This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants commenced in September 2018 and is estimated to be completed by March 2020. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12618001442291. Registered on 28 August 2018.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Seung Won Song ◽  
Kyung Yeon Yoo ◽  
Yong Sung Ro ◽  
Taehee Pyeon ◽  
Hong-Beom Bae ◽  
...  

Abstract Background Sugammadex is associated with few postoperative complications. Postoperative pulmonary complications (PPC) are related to prolonged hospitalizations. Present study explored whether the use of sugammadex could reduce PPCs and thereby reduce hospital length of stay (LOS) after lung surgery. Methods We reviewed the medical records of patients who underwent elective open lobectomy for lung cancer from January 2010 to December 2015. Patients were divided into the sugammadex group and pyridostigmine group. The primary outcome was hospital LOS and secondary outcomes were postoperative complications and overall survival at 1 year. The cohort was subdivided into patients with and without prolonged LOS to explore the effects of sugammadex on outcomes in each group. Risk factors for LOS were determined via multivariate analyses. After propensity score matching, 127 patients were assigned to each group. Results Median hospital LOS was shorter (10.0 vs. 12.0 days) and the incidence of postoperative atelectasis was lower (18.1 vs. 29.9%) in the sugammadex group. However, no significant difference in overall survival between the groups was seen over 1 year (hazard ratio, 0.967; 95% confidence interval, 0.363 to 2.577). Sugammadex was a predictor related to LOS (exponential coefficient 0.88; 95% CI 0.82–0.95). Conclusions Our data suggest that sugammadex is a preferable agent for neuromuscular blockade (NMB) reversal than cholinesterase inhibitors in this patient population. Trial registration This study registered in the Clinical Research Information Service of the Korea National Institute of Health (approval number: KCT0004735, Date of registration: 21 January 2020, Retrospectively registered).


2019 ◽  
Vol 9 (4) ◽  
pp. 263-268 ◽  
Author(s):  
Matthew Li ◽  
Mei H. Chang ◽  
Yeismel Miranda-Valdes ◽  
Kirsten Vest ◽  
Troy D. Kish

Abstract Introduction Intensive care unit (ICU) delirium is a major contributing factor to increased mortality, length of stay, and cost of care. Psychotropic medications may often require extensive tapering to prevent withdrawal symptoms; during ICU admission, home psychotropics are frequently held which may precipitate acute drug withdrawal and subsequent delirium. Methods This is a single-center, observational, retrospective chart review. The primary endpoint was the total number of new-start antipsychotics used to treat ICU delirium. Secondary endpoints included use of restraints, ICU length of stay, and hospital length of stay. Results A total of 2334 charts were reviewed for inclusion; 55 patients were categorized into each group. There was no statistically significant difference in the requirement for new-start antipsychotics (P = 1.0), restraint use (P = .057), or ICU length of stay (P = .71). There was a statistically significant decrease in hospital length of stay (P = .048). Discussion Early reinitiation was associated with a decrease in hospital length of stay but was not associated with a decrease in the number of new-start antipsychotics, use of restraints, or ICU length of stay.


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