scholarly journals Randomised Controlled Trial Assessing Head Down Deep Breathing Method Versus Modified Valsalva Manoeuvre for Treatment of Supraventricular Tachycardia in the Emergency Department

2021 ◽  
Vol 22 (4) ◽  
pp. 820-826
Author(s):  
Hoon Chin Lim ◽  
Yi-En Clara Seah ◽  
Arshad Iqbal ◽  
Vern Hsen Tan ◽  
Shieh Mei Lai
Keyword(s):  
Emergency Department ◽  
Randomised Controlled Trial ◽  
Adverse Effects ◽  
Sinus Rhythm ◽  
Supraventricular Tachycardia ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Valsalva Manoeuvre ◽  
Deep Breathing ◽  
Randomised Controlled

Introduction: Supraventricular tachycardia (SVT) is commonly encountered in the emergency department (ED). Vagal manoeuvres are internationally recommended therapy in stable patients. The head down deep breathing (HDDB) technique was previously described as an acceptable vagal manoeuvre, but there are no studies comparing its efficacy to other vagal manoeuvres. Our objective in this study was to compare the rates of successful cardioversion with HDDB and the commonly practiced, modified Valsalva manoeuvre (VM). Methods: We conducted a randomised controlled trial at an acute hospital ED. Patients presenting with SVT were randomly assigned to HDDB or modified VM in a 1:1 ratio. A block randomisation sequence was prepared by an independent biostatistician, and then serially numbered, opaque, sealed envelopes were opened just before the intervention. Patients and caregivers were not blinded. Primary outcome was cardioversion to sinus rhythm. Secondary outcome(s) included adverse effects/complications of each technique. Results: A total of 41 patients were randomised between 1 August, 2018–1 February, 2020 (20 HDDB and 21 modified VM). Amongst the 41 patients, three spontaneously cardioverted to sinus rhythm before receiving the allocated treatment and were excluded. Cardioversion was achieved in six patients (31.6%) and seven patients (36.8%) with HDDB and modified VM, respectively (odds ratio1.26, 95% confidence interval, 0.33, 4.84, P = 0.733) . Seventeen (89.5%) patients in the HDDB group and 14 (73.7%) from the modified VM group did not encounter any adverse effects. No major adverse cardiovascular events were recorded. Conclusion: Both the head down deep breathing technique and the modified Valsalva manoeuvre appear safe and effective in cardioverting patients with SVT in the ED.

scholarly journals Leg Lift Valsalva Maneuver for Treatment of Supraventricular Tachycardias

CJEM ◽  
2016 ◽  
Vol 19 (3) ◽  
pp. 235-237 ◽  
Author(s):  
Allison Michaud ◽  
Eddy Lang
Keyword(s):  
Randomised Controlled Trial ◽  
Sinus Rhythm ◽  
Supraventricular Tachycardia ◽  
Emergency Treatment ◽  
Valsalva Maneuver ◽  
Controlled Trial ◽  
Valsalva Manoeuvre ◽  
Clinical Question ◽  
Randomised Controlled ◽  
Supraventricular Tachycardias

Clinical questionCan conversion to sinus rhythm for a supraventricular tachycardia be enhanced by a postural modification to the Valsalva maneuver?Article chosenAppelboam A, Reuben A, Mann C, et al. Postural modification of the standard Valsalva manoeuvre for emergency treatment of supraventricular tachycardias (REVERT): a randomised controlled trial. Lancet 2015;386(10005):1747-53.1ObjectiveTo determine effectiveness of a postural modification of the Valsalva involving leg elevation and supine positioning.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma
Keyword(s):  
Intimate Partner Violence ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Partner Violence ◽  
Controlled Trial ◽  
Intimate Partner ◽  
Community Level ◽  
Secondary Outcome ◽  
Randomised Controlled ◽  
The Cost

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

scholarly journals Postcard intervention for repeat self-harm: randomised controlled trial

2010 ◽  
Vol 197 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Annette L. Beautrais ◽  
Sheree J. Gibb ◽  
Alan Faulkner ◽  
David M. Fergusson ◽  
Roger T. Mulder
Keyword(s):  
Emergency Department ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Suicidal Behaviour ◽  
Controlled Trial ◽  
Elevated Risk ◽  
Emergency Department Presentation ◽  
Self Harm ◽  
Randomised Controlled

BackgroundSelf-harm and suicidal behaviour are common reasons for emergency department presentation. Those who present with self-harm have an elevated risk of further suicidal behaviour and death.AimsTo examine whether a postcard intervention reduces self-harm re-presentations in individuals presenting to the emergency department.MethodRandomised controlled trial conducted in Christchurch, New Zealand. The intervention consisted of six postcards mailed during the 12 months following an index emergency department attendance for self-harm. Outcome measures were the proportion of participants re-presenting with self-harm and the number of re-presentations for self-harm in the 12 months following the initial presentation.ResultsAfter adjustment for prior self-harm, there were no significant differences between the control and intervention groups in the proportion of participants re-presenting with self-harm or in the total number of re-presentations for self-harm.ConclusionsThe postcard intervention did not reduce further self-harm. Together with previous results this finding suggests that the postcard intervention may be effective only for selected subgroups.

scholarly journals Training to enhance psychiatrist communication with patients with psychosis (TEMPO): cluster randomised controlled trial

2016 ◽  
Vol 209 (6) ◽  
pp. 517-524 ◽  
Author(s):  
Rose McCabe ◽  
Paula John ◽  
Jemima Dooley ◽  
Patrick Healey ◽  
Annie Cushing ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Therapeutic Relationship ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Medium Effect ◽  
Secondary Outcome ◽  
Shared Understanding ◽  
Cluster Randomised ◽  
Self Repair ◽  
Randomised Controlled

BackgroundA better therapeutic relationship predicts better outcomes. However, there is no trial-based evidence on how to improve therapeutic relationships in psychosis.AimsTo test the effectiveness of communication training for psychiatrists on improving shared understanding and the therapeutic relationship (trial registration: ISRCTN94846422).MethodIn a cluster randomised controlled trial in the UK, 21 psychiatrists were randomised. Ninety-seven (51% of those approached) out-patients with schizophrenia/schizoaffective disorder were recruited, and 64 (66% of the sample recruited at baseline) were followed up after 5 months. The intervention group received four group and one individualised session. The primary outcome, rated blind, was psychiatrist effort in establishing shared understanding (self-repair). Secondary outcome was the therapeutic relationship.ResultsPsychiatrists receiving the intervention used 44% more self-repair than the control group (adjusted difference in means 6.4, 95% CI 1.46–11.33, P<0.011, a large effect) adjusting for baseline self-repair. Psychiatrists rated the therapeutic relationship more positively (adjusted difference in means 0.20, 95% CI 0.03–0.37, P = 0.022, a medium effect), as did patients (adjusted difference in means 0.21, 95% CI 0.01–0.41, P = 0.043, a medium effect).ConclusionsShared understanding can be successfully targeted in training and improves relationships in treating psychosis.

scholarly journals Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e021783 ◽  
Author(s):  
Shan Chen ◽  
Siyou Wang ◽  
Lihua Xuan ◽  
Hanti Lu ◽  
Zhikai Hu ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Randomised Controlled Trial ◽  
Medical Care ◽  
Outcome Measures ◽  
Pudendal Nerve ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Routine Medical Care ◽  
Randomised Controlled

IntroductionElectroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.Methods and analysisThis is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.Ethics and disseminationThis protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.Trial registration numberChiCTR-IOR-17012847; Pre-result.

scholarly journals Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department: study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e025339 ◽  
Author(s):  
Edward Carlton ◽  
Sarah Campbell ◽  
Jenny Ingram ◽  
Rebecca Kandiyali ◽  
Hazel Taylor ◽  
...  
Keyword(s):  
Emergency Department ◽  
Chest Pain ◽  
Randomised Controlled Trial ◽  
Limit Of Detection ◽  
Controlled Trial ◽  
High Sensitivity ◽  
Early Discharge ◽  
High Sensitivity Troponin ◽  
Randomised Controlled ◽  
Rule Out

IntroductionObservational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%–60% of ED patients with chest pain. This is done using an ‘undetectable’ cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients.Methods and analysisThis is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate.Ethics and disseminationThe study has been approved by the Frenchay Research Ethics Committee (reference 18/SW/0038). Results will be published in an international peer-reviewed journal. Lay summaries will be made available to patients.Trial registration numberISRCTN86184521; Pre-results.

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