Application of a protective sleeve is associated with decreased occupational anxiety during endotracheal intubation: a randomized controlled trial

Abstract Background The high risk of cross-infection during tracheal intubation has caused excessive occupational anxiety for anaesthesiologists amid the novel coronavirus disease 2019 (COVID-19) pandemic. Currently, there is no effective way to attenuate their anxiety in clinical practice. We found that anaesthesiologist with better protective equipment might experience decreased levels of anxiety during intubation. Methods In this study, 60 patients who underwent intubation and extubation in the operating room were enrolled, and then randomized 1:1 to either wear protective sleeves (protective sleeve group) or not (control group). Visual analogue scale (VAS) was used to measure the anxiety level of anaesthesiologists during intubation. The respiratory droplets of patients on the sleeve, and the anaesthesiologists’ perception including the patient’s oral malodour, exertion, satisfaction degree, waist discomfort and shoulder discomfort were recorded. The patients’ anxiety, oppressed feelings and hypoxia and postoperative complications were all measured and recorded. Results Compared with the control group, the anaesthesiologists in protective sleeve group achieved lower anxiety scores and better satisfaction degrees during the process of intubation and extubation (all P < 0.05). Respiratory droplets were observed only on the inner side, but not the external side, of the protective sleeves (P < 0.001). The incidence of the anaesthesiologists’ perception of patients’ oral malodour was significantly lower in the protective sleeve group (P = 0.02) and no patients developed hypoxemia or intubation-related complications in the protective sleeve group. Conclusion Using protective devices for intubation might eliminate droplet transmission from patients to anaesthesiologists, while also decreasing their anxiety in a controlled operating room environment. Trial registration Chinese Clinical Trial. no. ChiCTR2000030705. Registry at www.chictr.org.cn on 10/03/2020.

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Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽

10.1186/s12912-021-00616-0 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Olga L. Cortés ◽

Mauricio Herrera-Galindo ◽

Juan Carlos Villar ◽

Yudi A. Rojas ◽

María del Pilar Paipa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Critical Care ◽

Pressure Ulcers ◽

Controlled Trial ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Link Type ◽

Cluster Randomized ◽

The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

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Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00788-1 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Laura Williams ◽

Charlotte L. Hall ◽

Sue Brown ◽

Boliang Guo ◽

Marilyn James ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young People ◽

Controlled Trial ◽

Medication Management ◽

Control Group ◽

Global Functioning ◽

Children And Young People ◽

Link Type ◽

Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke

Neurology ◽

10.1212/wnl.0000000000011440 ◽

2021 ◽

pp. 10.1212/WNL.0000000000011440

Author(s):

Jong-Won Chung ◽

Won Hyuk Chang ◽

Oh Young Bang ◽

Gyeong Joon Moon ◽

Suk Jae Kim ◽

...

Keyword(s):

Stem Cells ◽

Mesenchymal Stem Cells ◽

Controlled Trial ◽

Outcome Evaluation ◽

Autologous Serum ◽

Secondary Outcome ◽

Control Group ◽

Link Type ◽

Significant Difference ◽

Major Stroke

ObjectiveTo test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.MethodsIn this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.ResultsA total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range, 28–83) years, and mean interval between stroke onset to randomization was 20.2 (range, 5–89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months (p = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, p = 0.023), which was notable among patients with low predicted recovery potential. There were no serious, treatment-related adverse events.ConclusionsIntravenous application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.Classification of evidenceThis study provides Class III evidence that autologous mesenchymal stem cells do not improve 90-day outcomes in patients with chronic stroke.Trial registrationclinicaltrials.gov Identifier: NCT01716481.

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Effects of PACK guide training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians: a pragmatic cluster randomised controlled trial in Florianópolis, Brazil

BMJ Global Health ◽

10.1136/bmjgh-2019-001921 ◽

2019 ◽

Vol 4 (6) ◽

pp. e001921

Author(s):

Max Oscar Bachmann ◽

Eric D Bateman ◽

Rafael Stelmach ◽

Alvaro A Cruz ◽

Matheus Pacheco de Andrade ◽

...

Keyword(s):

Chronic Obstructive Pulmonary Disease ◽

Primary Care ◽

Pulmonary Disease ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Link Type ◽

To Receive

IntroductionThe Practical Approach to Care Kit (PACK) guide was localised for Brazil, where primary care doctors and nurses were trained to use it.MethodsTwenty-four municipal clinics in Florianópolis were randomly allocated to receive outreach training and the guide, and 24 were allocated to receive only the guide. 6666 adult patients with asthma or chronic obstructive pulmonary disease (COPD) were enrolled, and trial outcomes were measured over 12 months, using electronic medical records. The primary outcomes were composite scores of treatment changes and spirometry, and new asthma and COPD diagnosis rates.ResultsAsthma scores in 2437 intervention group participants were higher (74.8%, 20.4% and 4.8% with scores of 0, 1 and 2, respectively) than in 2633 control group participants (80.0%, 16.8% and 3.2%) (OR for higher score 1.32, 95% CI 1.08 to 1.61, p=0.006). Adjusted for asthma scores recorded in each clinic before training started, the OR was 1.24 (95% CI 1.03 to 1.50, p=0.022). COPD scores in 1371 intervention group participants (77.7%, 17.9% and 4.3% with scores of 0, 1 and 2) did not differ from those in 1181 control group participants (80.5%, 15.8% and 3.7%) (OR 1.21, 95% CI 0.94 to 1.55, p=0.142). Rates of new asthma and COPD diagnoses, and hospital admission, and indicators of investigation, diagnosis and treatment of comorbid cardiovascular disease, diabetes and depression, and tobacco cessation did not differ between trial arms.ConclusionPACK training increased guideline-based treatment and spirometry for asthma but did not affect COPD or comorbid conditions, or diagnosis rates.Trial registrationNCT02786030 (https://clinicaltrials.gov/).

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OverCOVID: an integrative web portal for SARS-CoV-2 bioinformatics resources

Journal of Integrative Bioinformatics ◽

10.1515/jib-2020-0046 ◽

2021 ◽

Vol 18 (1) ◽

pp. 9-17 ◽

Cited By ~ 1

Author(s):

Md. Asif Ahsan ◽

Yongjing Liu ◽

Cong Feng ◽

Ralf Hofestädt ◽

Ming Chen

Keyword(s):

Clinical Research ◽

Human Health ◽

Clinical Data ◽

The Novel ◽

Web Portal ◽

Vast Amount ◽

Link Type ◽

Other Information ◽

Novel Coronavirus ◽

The Web

Abstract Outbreaks of COVID-19 caused by the novel coronavirus SARS-CoV-2 is still a threat to global human health. In order to understand the biology of SARS-CoV-2 and developing drug against COVID-19, a vast amount of genomic, proteomic, interatomic, and clinical data is being generated, and the bioinformatics researchers produced databases, webservers and tools to gather those publicly available data and provide an opportunity of analyzing such data. However, these bioinformatics resources are scattered and researchers need to find them from different resources discretely. To facilitate researchers in finding the resources in one frame, we have developed an integrated web portal called OverCOVID (http://bis.zju.edu.cn/overcovid/). The publicly available webservers, databases and tools associated with SARS-CoV-2 have been incorporated in the resource page. In addition, a network view of the resources is provided to display the scope of the research. Other information like SARS-CoV-2 strains is visualized and various layers of interaction resources is listed in distinct pages of the web portal. As an integrative web portal, the OverCOVID will help the scientist to search the resources and accelerate the clinical research of SARS-CoV-2.

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Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial

Trials ◽

10.1186/s13063-021-05724-5 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Céline K. Stäuble ◽

Markus L. Lampert ◽

Samuel Allemann ◽

Martin Hatzinger ◽

Kurt E. Hersberger ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Antidepressant Treatment ◽

Controlled Trial ◽

Response Rates ◽

Control Group ◽

Open Label ◽

Randomized Controlled ◽

Link Type ◽

Increased Risk ◽

Antidepressant Pharmacotherapy

Abstract Background It is known that only 50% of patients diagnosed with major depressive disorders (MDD) respond to the first-line antidepressant treatment. Accordingly, there is a need to improve response rates to reduce healthcare costs and patient suffering. One approach to increase rates of treatment response might be the integration of pharmacogenetic (PGx) testing to stratify antidepressant drug selection. The goal of PGx assessments is to identify patients who have an increased risk to experience adverse drug reactions or non-response to specific drugs. Especially for antidepressants, there is compiling evidence on PGx influencing drug exposure as well as response. Methods This study is an open-label, randomized controlled trial conducted in two study centers in Switzerland: (1) the Psychiatric Clinic of Solothurn and (2) the Private Clinic Wyss in Münchenbuchsee. Adult inpatients diagnosed with a unipolar moderate or severe depressive episode are recruited at clinic admission and are included in the study. If the adjustment to a new antidepressant pharmacotherapy is necessary, the participants are randomized to either Arm A (intervention group) or Arm B (control group). If no new antidepressant pharmacotherapy is introduced the participants will be followed up in an observational arm. The intervention is the service of pharmacist-guided pre-emptive PGx testing to support clinical decision making on antidepressant selection and dosing. As a comparison, in the control group, the antidepressant pharmacotherapy is selected by the treating physician according to current treatment guidelines (standard of care) without the knowledge of PGx test results and support of clinical pharmacists. The primary outcome of this study compares the response rates under antidepressant treatment after 4 weeks between intervention and control arm. Discussion The findings from this clinical trial are expected to have a direct impact on inter-professional collaborations for the handling and use of PGx data in psychiatric practice. Trial registration ClinicalTrials.govNCT04507555. Registered on August 11, 2020. Swiss National Clinical Trials Portal SNCTP000004015. Registered August 18, 2020.

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Tracking and Classifying Global COVID-19 Cases by using 1D Deep Convolution Neural Networks

10.1101/2020.06.09.20126565 ◽

2020 ◽

Author(s):

Mark Amo-Boateng

Keyword(s):

Neural Networks ◽

Time Series ◽

Time Series Data ◽

Sequence Data ◽

Series Data ◽

The Novel ◽

Response Curves ◽

Convolution Neural Networks ◽

Link Type ◽

Novel Coronavirus

ABSTRACTThe novel coronavirus disease (COVID-19) and pandemic has taken the world by surprise and simultaneously challenged the health infrastructure of every country. Governments have resorted to draconian measures to contain the spread of the disease despite its devastating effect on their economies and education. Tracking the novel coronavirus 2019 disease remains vital as it influences the executive decisions needed to tighten or ease restrictions meant to curb the pandemic. One-Dimensional (1D) Convolution Neural Networks (CNN) have been used classify and predict several time-series and sequence data. Here 1D-CNN is applied to the time-series data of confirmed COVID-19 cases for all reporting countries and territories. The model performance was 90.5% accurate. The model was used to develop an automated AI tracker web app (AI Country Monitor) and is hosted on https://aicountrymonitor.org. This article also presents a novel concept of pandemic response curves based on cumulative confirmed cases that can be use to classify the stage of a country or reporting territory. It is our firm believe that this Artificial Intelligence COVID-19 tracker can be extended to other domains such as the monitoring/tracking of Sustainable Development Goals (SDGs) in addition to monitoring and tracking pandemics.

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Insights into pathophysiology, immune response and treatment of novel CoVID-19

Research Journal of Biotechnology ◽

10.25303/1610rjbt189197 ◽

2021 ◽

Vol 16 (10) ◽

pp. 189-197

Author(s):

Manpreet Kaur ◽

Rajinder Kaur ◽

Reena Gupta

Keyword(s):

Immune Response ◽

World Health ◽

The Novel ◽

Asian Countries ◽

Human Lungs ◽

Potential Vaccine ◽

Novel Coronavirus ◽

Health Organization ◽

Respiratory Droplets ◽

Alveolar Edema

The beginning of year 2020 has brought with it mass destruction of mankind in form of novel coronavirus, named as CoVID-19. Declared as pandemic by World Health Organization (WHO), CoVID-19 has its origin in bats and pangolin from which it was probably transferred to human. Subsequent human to human transmission has been seen by respiratory droplets, fomites and oral-fecal route. The disease has caused widespread deaths in America, China, France and Italy followed by many European and Asian countries. CoVID-19 targets the human lungs and multiplies in alveoli using host machinery. Interstitial edema and alveolar edema at later stages cause alveoli collapse and difficulty in breathing. Severe cases may pave to systemic inflammatory response that has fatal response in body. Unfortunately, researchers are still struggling for potential vaccine or promising drug to combat the disease. WHO has issued guidelines suggesting regular hand washing, social distancing, wearing masks and quarantination as the best ways to prevent infection. This review gives an overview of the novel CoVID-19, conditions and immune response of human body related with it.

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An Ayurvedic perspective of COVID 19: A Pandemic Situation

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v11ispl1.4191 ◽

2020 ◽

Vol 11 (SPL1) ◽

pp. 1627-1634

Author(s):

Megha Dipak Rudey ◽

Renu Rathi ◽

Bharat Rathi

Keyword(s):

Close Contact ◽

Infected Individual ◽

Preventive Measure ◽

System Capacity ◽

The Novel ◽

Unique Method ◽

Poor Outcomes ◽

Novel Coronavirus ◽

Respiratory Droplets ◽

Transmission Of Disease

COVID-19 (Novel coronavirus or corona disease is spreading continuously all over the world. Overloading of ICU and health care system capacity. Along with age factor, community spread, vertical transmission of disease and clinical manifestation is the risk factor for the poor outcomes. The transmission is mainly through respiratory droplets when individual sneezes or coughs and also due to the close contact with an infected individual. Every researcher is in found of preventive measure, and in found of effective treatment for it. As the population is rushing to keep themselves protected from the infection, Ayurveda practitioners are in stress that the kalpas cited in Ayurveda literature will be helpful in strengthening the immunity and to fight against COVID-19. It is an attempt to study the Novel Coronavirus (COVID-19) it's clinical diagnostic and management in Ayurveda perspective. Various Samhitas, such as Charaka Samhita, Ashtanga Hridaya, Madhava Nidana articles were referred for this study. According to Ayurveda literature, a unique method of impending a fresh identified illness Rather than centring on the bacteriological etiology, Ayurveda encirclements a universal skill for particularising the details of the illness at hand. Till the date, no vaccination is being found for COVID-19 yet, but the concepts given in Vedas have information about diagnostic and management. This attempt is to encourage Ayurveda practitioners and young researcher’s to work on the formulations, which are cited thousands of years ago to breakdown the pathology of disease and work for the development and promotion of Ayurveda.

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