scholarly journals BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047790
Author(s):  
Brian Driver ◽  
Matthew W Semler ◽  
Wesley H Self ◽  
Adit A Ginde ◽  
Sheetal Gandotra ◽  
...  
Keyword(s):  
Medical Center ◽  
Randomised Trial ◽  
Randomised Clinical Trial ◽  
Orotracheal Intubation ◽  
Statistical Analysis Plan ◽  
Institutional Review Board ◽  
Secondary Outcome ◽  
Intubation Attempt ◽  
Institutional Review ◽  
The Usa

IntroductionIntubation-related complications are less frequent when intubation is successful on the first attempt. The rate of first attempt success in the emergency department (ED) and intensive care unit (ICU) is typically less than 90%. The bougie, a semirigid introducer that can be placed into the trachea to facilitate a Seldinger-like technique of tracheal intubation and is typically reserved for difficult or failed intubations, might improve first attempt success. Evidence supporting its use, however, is from a single academic ED with frequent bougie use. Validation of these findings is needed before widespread implementation.Methods and analysisThe BOugie or stylet in patients Undergoing Intubation Emergently trial is a prospective, multicentre, non-blinded randomised trial being conducted in six EDs and six ICUs in the USA. The trial plans to enrol 1106 critically ill adults undergoing orotracheal intubation. Eligible patients are randomised 1:1 for the use of a bougie or use of an endotracheal tube with stylet for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcome is severe hypoxaemia, defined as an oxygen saturation less than 80% between induction until 2 min after completion of intubation. Enrolment began on 29 April 2019 and is expected to be completed in 2021.Ethics and disseminationThe trial protocol was approved with waiver of informed consent by the Central Institutional Review Board at Vanderbilt University Medical Center or the local institutional review board at an enrolling site. The results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.Trial registration numberClinicalTrials.gov Registry (NCT03928925).

scholarly journals Tablet-based sensorimotor home-training system for amnestic mild cognitive impairments in the elderly: design of a randomised clinical trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e028632 ◽  
Author(s):  
Robin Bekrater-Bodmann ◽  
Annette Löffler ◽  
Stefano Silvoni ◽  
Lutz Frölich ◽  
Lucrezia Hausner ◽  
...  
Keyword(s):  
Brain Plasticity ◽  
Cognitive Impairments ◽  
Memory Function ◽  
Randomised Trial ◽  
The Elderly ◽  
Randomised Clinical Trial ◽  
Training System ◽  
Secondary Outcome ◽  
Sensorimotor Training ◽  
Positive Effects

IntroductionDementia (particularly Alzheimer’s disease, AD) is a major cause of impaired cognitive functions in the elderly. Amnestic mild cognitive impairment (aMCI) is a prodromal stage of AD, if substantiated by Alzheimer biomarkers. A neuroscientific model of pathological ageing emphasises the loss of brain plasticity, sensorimotor capacities and subsequent cognitive decline. A mechanistic treatment targeting dysfunctional plastic changes associated with ageing should be efficacious in delaying AD. In this trial, we aim to evaluate the effectiveness of a newly developed sensorimotor training, delivered at home, combined with personalised reinforcement, on the progression of aMCI-related cognitive impairments.Methods and analysisIn a randomised trial, we will compare two aMCI groups (30 subjects each), randomly allocated to a sensorimotor or a cognitive control training. Both trainings consist of an adaptive algorithm, and will last 3 months each. We hypothesise that both trainings will have positive effects on cognitive function with the sensorimotor training being superior compared with the control training based on its improvement in basic perceptual skills underlying memory encoding and retrieval. The primary outcome is episodic memory function, improved hippocampal function during memory tasks will be a secondary outcome. As further exploratory outcomes, we expect improved segregation in sensory and motor maps, better sensory discrimination only in the sensorimotor training and reduced transition to dementia (examined after completion of this study). We expect the experimental training to be evaluated more positively by the users compared with the cognitive training, resulting in reduced rates of discontinuation.Ethics and disseminationThe Ethics Committee of the Medical Faculty Mannheim, Heidelberg University, approved the study (2015–543N-MA), which adheres to the Declaration of Helsinki. The results will be published in a peer-reviewed journal. Access to raw data is available on request.Trial registration numberDRKS00012748.

scholarly journals Time Required for Institutional Review Board Review at One Veterans Affairs Medical Center

JAMA Surgery ◽  
2015 ◽  
Vol 150 (2) ◽  
pp. 103 ◽  
Author(s):  
Daniel E. Hall ◽  
Barbara H. Hanusa ◽  
Roslyn A. Stone ◽  
Bruce S. Ling ◽  
Robert M. Arnold
Keyword(s):  
Medical Center ◽  
Veterans Affairs ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Institutional Review Board Review ◽  
Board Review ◽  
Time Required

scholarly journals A Randomised Clinical Trial to Compare the Effectiveness of Baska Mask Versus i-gel in Patients Undergoing Laparoscopic Surgeries in a Tertiary Centre

2021 ◽  
Vol 8 (24) ◽  
pp. 2040-2044
Author(s):  
Anil Kumar Mysore Ramakrishna ◽  
Sarika Manjunath Shetty ◽  
Anup Natha Ramachandragowda ◽  
Vyshnavi Sriram ◽  
Shali Sohail ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Randomised Clinical Trial ◽  
Airway Device ◽  
Supraglottic Airway ◽  
Secondary Outcome ◽  
Tertiary Centre ◽  
Group I ◽  
Supraglottic Airway Devices ◽  
Sealing Pressure ◽  
The Impact

BACKGROUND A wide array of supraglottic airway devices (SAD) are available for the present day anaesthetic practice, each having its own unique features. Laparoscopic surgeries demand meticulous airway maintenance due to the impact of pneumoperitoneum on cardiorespiratory physiology. It thus becomes imperative to have knowledge about the most optimal SAD that can be used for laparoscopic surgeries to provide good quality anaesthesia. The objective of this randomised trial was to compare the airway sealing pressure (ASP) of Baska mask and i-gel and overall success rate in patients undergoing laparoscopic surgeries under general anaesthesia and controlled ventilation. METHODS One hundred and forty patients undergoing laparoscopic surgeries were randomly assigned to either Baska group (Group B) or i-gel group (Group I). Anaesthesia was induced with propofol 2 - 2.5 milligram per kilogram (mg / kg) and relaxation achieved with vecuronium 0.1 mg / kg and SAD was inserted. The primary outcome was airway sealing pressure (ASP) noted after insertion of the device. The secondary outcome measures included the number of attempts and time taken for successful insertion, ASP after gas insufflation of abdomen, Brimacombe grading, hemodynamic changes, airway morbidity (blood on the SAD upon removal, post-operative sore throat, dysphagia and dysphonia) and any other adverse events associated with the use of the devices. RESULTS There were no significant differences in demographic and hemodynamic data. ASP after insertion of the device was significantly higher (p < 0.0001) with Baska than i-gel (41.45 + 4.72 versus 30.29 + 5.76 cm H2O respectively). Brimacombe scoring of grade four was seen in 75.3 % of Baska compared to 18 % in i-gel group. Time taken to insert Baska was significantly more than with i-gel (14.84 versus 11.25 seconds respectively, P < 0.001). However, first time success was more with Baska than with i-gel (147 versus 140 respectively). CONCLUSIONS Both Baska and i-gel can be used safely and effectively in laparoscopic surgeries. Baska provides a better ASP and Brimacombe view than i-gel. However, i-gel offers the advantage of easier insertion in shorter time. KEYWORDS Supraglottic Airway Device, Baska Mask, i-gel, Airway Sealing Pressure

scholarly journals Efficacy of an educational intervention on students' attitudes regarding spirituality in healthcare: a cohort study in the USA

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e026358 ◽  
Author(s):  
Zachary Paul Wargo Smothers ◽  
Jennifer Young Tu ◽  
Colleen Grochowski ◽  
Harold G Koenig
Keyword(s):  
Cohort Study ◽  
Medical Students ◽  
Educational Intervention ◽  
Medical Center ◽  
Academic Medical Center ◽  
Secondary Outcome ◽  
Future Research ◽  
Group Setting ◽  
The Usa ◽  
Students Attitudes

ObjectiveTo determine if an educational intervention focused on the role of spirituality in healthcare positively affects medical students' attitudes and perceptions relating to this topic.DesignA pre-post cohort study.SettingAn undergraduate medical institution affiliated with an academic medical center in the USA.ParticipantsA total of 110 medical students currently on their clinical rotations received the educational intervention, of whom 71 (65%) completed both the presurvey and postsurvey. Demographic variables did not significantly differ from the national average of medical students, or from a comparison group. All students who attended the intervention were given the opportunity to participate in the survey.InterventionsThe educational intervention consisted of a 60-minute lecture focusing on religion/spirituality (R/S) in healthcare, followed by a 90-minute case discussion in a small group setting.Primary and secondary outcome measuresAssessment consisted of 18-item preintervention and postintervention survey quantifying student’s attitudes towards, comfort with, and perceptions of R/S in healthcare.ResultsAttitudes towards, comfort with, and perceptions of R/S in healthcare were generally positive preintervention. Following the intervention, students expressed an increased willingness to include R/S competency in their future practice (p=0.001), were more comfortable sharing their own R/S beliefs with a patient when appropriate (p=0.02), and were more willing to approach a patient with R/S concern (p=0.04). The other surveyed attitudes demonstrated positive, but non-significant improvement.ConclusionAn educational intervention focusing on approaching patients with R/S concerns has the ability to improve the attitudes and comfort of medical students. By incorporating a total of 150 minutes of education about R/S, medical schools can help develop this particular area of cultural competence, preparing a generation of physicians to professionally approach R/S concerns of patients. Future research should move beyond quantifying attitudes and strive to understand changes in knowledge and student behaviour.

scholarly journals 622 PD-L1 is a potential predictive biomarker for response to RM-1929 treatment in recurrent head and neck squamous cell carcinoma patients

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A658-A658
Author(s):  
C Daniel De Magalhaes Filho ◽  
Chung-Wein Lee ◽  
Nikolai Suslov ◽  
Jerry Fong ◽  
Miguel Garcia-Guzman
Keyword(s):  
Head And Neck ◽  
Response Rate ◽  
Medical Center ◽  
Predictive Biomarker ◽  
Institutional Review Board ◽  
Cancer Center ◽  
University Of Texas ◽  
University Of Oklahoma ◽  
Institutional Review ◽  
Oklahoma Health

BackgroundRM-1929 is an antibody-dye conjugate comprised of cetuximab covalently linked to the photoactivable dye, IRDye® 700DX (IR700). After systemic infusion of RM-1929, illumination of the tumor with 690 nm non-thermal red light activates the drug and results in targeted and rapid tumor necrosis. Previous preclinical data have shown that RM-1929 treatment triggers immunogenic cell death and activates the innate and adaptive immune response. A retrospective analysis of PD-L1 expression from the phase I/IIa clinical trial in patients with recurrent head and neck squamous cell carcinoma (rHNSCC) (NCT02422979) was conducted. The analysis explored correlations of PD-L1 expression, including combined proportion score (CPS) and tumor proportion score (TPS), with clinical outcomes such as response rate and overall survival.MethodsPD-L1 expression prior to RM-1929 treatment was assessed by immunohistochemistry in 18 out of 30 patients enrolled in Part II of the trial, based on sample availability. PD-L1 expression was evaluated using TPS and CPS. Responders were defined as patients that achieved complete response or partial response, and non-responders had either stable disease or progressive disease. Overall survival (OS) was analyzed using the Kaplan-Meier method.ResultsResponders (n=10) had a TPS of 4.3±2.4 (mean±SEM), which was substantially lower than in non-responders (n=8) with a TPS of 39.4±11.8. Similarly, CPS was lower in responders (8.6±3.6) compared to non-responders (50.0±13.5). The best target response rate for all patients included in this analysis was 56%. Patients with CPS=40 had a response rate of 76.9% (n=13) compared to 0% in patients with CPS>40 (n=5). This suggests that a CPS cut-off of =40 led to enrichment of the best target response rate. The median OS of patients with CPS=40 (13.0±0.8 months) was also higher than in patients with CPS>40 (3.1±0.8 months) and in all patients (12.0±2.9 months).ConclusionsThese results suggest that rHNSCC patients with lower PD-L1 expression levels may be more responsive to RM-1929 treatment and CPS/TPS could potentially be predictive biomarkers in identifying patients with a higher probability of benefiting from this treatment. Given the limited number of patients in this analysis, additional clinical trials will be needed to validate PD-L1 expression as an effective predictive biomarker for RM-1929 treatment.AcknowledgementsThe authors would like to thank all patients and their families for their participation in this trial. The authors would also like to thank the following investigators for the contribution of samples included in this trial analysis: Dr. David Cognetti (Thomas Jefferson University Hospital), Dr. Ann M Gillenwater (University of Texas MD Anderson Cancer Center), Dr. Mary Jo Fidler (Rush University Medical Center), Dr. Samith T. Kochuparambil (Virginia Piper Cancer Institute ), Dr. John Campana (University of Colorado Head and Neck Specialists), and Dr. Nilesh R. Vasan (University of Oklahoma Health Sciences Center).Trial RegistrationNCT02422979Ethics ApprovalThe trial was approved by the following Instution Ethics Boards and IRB# as listed: UCSF Institutional Review Board (#17-21904), Thomas Jefferson University, IRB (#16C.328), University of Oklahoma Health Sciences Center Institutional Review Board (#5723), University of Texas MD Anderson Cancer Center - Institutional Review Board (#IRB 2 IRB00002203), Quorum Review IRB (#30458/1), Rush University Medical Center Institutional Review Board (#15030601-IRB01), and Catholic Health Initiatives Institute for Research and Innovation (CIRI) Institutional Review Board (CHIRB) (# IRB00009715).ConsentN/A

Statistical analysis plan for the Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure trial

2020 ◽  
Vol 22 (1) ◽  
pp. 63-71
Author(s):  
Rameela Chandrasekhar ◽  
◽  
Christopher G Hughes ◽  
Brenda T Pun ◽  
Onur M Orun ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Randomised Trial ◽  
Randomised Clinical Trial ◽  
Statistical Analysis Plan ◽  
Brain Dysfunction ◽  
Neurological Dysfunction ◽  
Long Term Effects ◽  
Double Blind ◽  
Mechanically Ventilated

BACKGROUND: The best sedative medication to reduce delirium, mortality and long term brain dysfunction in mechanically ventilated septic patients is unclear. This multicentre, double-blind, randomised trial investigates the short term and long term effects of dexmedetomidine versus propofol for sedation in mechanically ventilated severely septic patients. OBJECTIVES: To describe the statistical analysis plan for this randomised clinical trial comprehensively and place it in the public domain before unblinding. METHODS: To ensure that analyses are not selectively reported, we developed a comprehensive statistical analysis plan before unblinding. This trial has an enrolment target of 420 severely septic and mechanically ventilated adult patients, randomly assigned to dexmedetomidine or propofol in a 1:1 ratio. Enrolment was completed in January 2019, and the study was estimated to be completed in September 2019. The primary endpoint is days alive without delirium or coma during first 14 study days. Secondary outcomes include 28-day ventilator-free days, 90-day all-cause mortality and cognitive function at 180 days. Time frames all begin on the day of randomisation. All analyses will be conducted on an intention-to-treat basis. CONCLUSION: This study will compare the effects of two sedatives in mechanically ventilated severely septic patients. In keeping with the guidance on statistical principles for clinical trials, we have developed a comprehensive statistical analysis plan by which we will adhere, as this will avoid bias and support transparency and reproducibility. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01739933).

scholarly journals New model of integrated care for uncontrolled type 2 diabetes in a retrospective, underserved adult population in the USA: a study protocol for an effectiveness and cost-effectiveness analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038084
Author(s):  
Rita Bosetti ◽  
Laila Tabatabai ◽  
George Naufal ◽  
Rosbel Brito ◽  
Bita Kash
Keyword(s):  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Patient Outcomes ◽  
Diabetes Care ◽  
Institutional Review Board ◽  
New Model ◽  
Institutional Review ◽  
The Usa ◽  
The Cost

IntroductionType 2 diabetes prevalence is increasing in the USA, especially in underserved populations. Patient outcomes can be improved by providing access to specialty care within Federally Qualified Health Centers, possibly improving the cost-effectiveness of diabetes care.Methods and analysisA new model of diabetes care based on multidisciplinary teams of clinical fellows, supported by an endocrinologist for underserved adult populations, is presented. The study uses a retrospective, non-randomised cohort of patients with diabetes who visited the community clinic between 1 January 2012 and 31 December 2018. A quasi-experimental method to analyse the causal evidence of the effect of the new model is presented. Discontinuity regression is used to compare two interventions, the intervention by a Clinical Fellow Endocrinology Programme and usual care by a primary care physician. Patients are referred to the Clinical Fellow Endocrinology Programme in case of uncontrolled diabetes (glycated haemoglobin (HbA1c)≥9%). The regression discontinuity design allows the construction of a treatment group for patients with an HbA1c equal or above the threshold in comparison with a control group for patients with an HbA1c below the threshold. The patient outcomes and cost-effectiveness of the new model are analysed. Regression models will be used to assess the differences between treatment and control groups.Ethics and disseminationQuantitative patient data are received by the study team in a de-identified format for analysis via an institutional review board-approved protocol. The quantitative study has been approved by the Houston Methodist Research Institute Institutional Review Board, Houston, Texas, USA. Anticipated results will not only provide evidence about the impact of patient outcomes in underserved diabetic populations, but also give an idea of the cost-effectiveness of the new model and whether or not cost savings can be attained for patients, third-party payers and society. The results will help set up evidence-based policy guidelines in diabetes care. Results will be disseminated through papers, conferences and public health/policy fora.

scholarly journals Integrity of clinical information in computerized order requisitions for diagnostic imaging

2018 ◽  
Vol 25 (12) ◽  
pp. 1651-1656 ◽  
Author(s):  
Ronilda Lacson ◽  
Romeo Laroya ◽  
Aijia Wang ◽  
Neena Kapoor ◽  
Daniel I Glazer ◽  
...  
Keyword(s):  
Medical Center ◽  
Academic Medical Center ◽  
Clinical Information ◽  
Clinical Decision ◽  
Accurate Diagnosis ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Academic Medical ◽  
Potential Impact ◽  
Kappa Agreement

Abstract Objective Assess information integrity (concordance and completeness of documented exam indications from the electronic health record [EHR] imaging order requisition, compared to EHR provider notes), and assess potential impact of indication inaccuracies on exam planning and interpretation. Methods This retrospective study, approved by the Institutional Review Board, was conducted at a tertiary academic medical center. There were 139 MRI lumbar spine (LS-MRI) and 176 CT abdomen/pelvis orders performed 4/1/2016-5/31/2016 randomly selected and reviewed by 4 radiologists for concordance and completeness of relevant exam indications in order requisitions compared to provider notes, and potential impact of indication inaccuracies on exam planning and interpretation. Forty each LS-MRI and CT abdomen/pelvis were re-reviewed to assess kappa agreement. Results Requisition indications were more likely to be incomplete (256/315, 81%) than discordant (133/315, 42%) compared to provider notes (p &lt; 0.0001). Potential impact of discrepancy between clinical information in requisitions and provider notes was higher for radiologist’s interpretation than for exam planning (135/315, 43%, vs 25/315, 8%, p &lt; 0.0001). Agreement among radiologists for concordance, completeness, and potential impact was moderate to strong (Kappa 0.66-0.89). Indications in EHR order requisitions are frequently incomplete or discordant compared to physician notes, potentially impacting imaging exam planning, interpretation and accurate diagnosis. Such inaccuracies could also diminish the relevance of clinical decision support alerts if based on information in order requisitions. Conclusions Improved availability of relevant documented clinical information within EHR imaging requisition is necessary for optimal exam planning and interpretation.

scholarly journals Osseointegration Implant Post Coupling With External Prosthetic Limb – Continuation of Previous Case Reports “Stage III”

2014 ◽  
Vol 4 (2) ◽  
pp. 13-16 ◽  
Author(s):  
Ronald Hillock, MD ◽  
Danny Tatum, BCP ◽  
Edward Dolegowski, PT
Keyword(s):  
Medical Center ◽  
Case Reports ◽  
Institutional Review Board ◽  
Concept Design ◽  
Prosthetic Limb ◽  
Therapy Program ◽  
Joint Implant ◽  
Institutional Review ◽  
Physical Therapy Program ◽  
Post Coupling

An ongoing update of the progress case report for the first patient treated with the Longitude™ osseointegration prosthesis implanted in an amputated residual femur is presented. The patient was given an intensive physical therapy program of strengthening and conditioning in anticipation of coupling to the external prosthesis. A custom prosthesis was fabricated based on the Plie’ 2.0 microprocessor knee system. The patient was then successfully trained on use and care of the prosthesis for ambulation without any complications.Keywords: Amputation, OsseointegrationAcknowledgement: Design concept by Concept Design & Development, LLC (CDD,LLC); Development and Manufacturing by Signature Orthopaedics, LTD; Centennial Hills Hospital Medical Center, Las Vegas, NV; and Institutional Review Board (IRB) by Joint Implant Surgery & Research Foundation.

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