scholarly journals β-Hydroxy-β-Methylbutrate (HMB) Supplementation and Functional Outcomes in Multi-trauma Patients: A Study Protocol for a Pilot Randomised Clinical Trial (BOOST trial)

2021 ◽  
Author(s):  
Kym Wittholz ◽  
Kate Fetterplace ◽  
Yasmine Ali Abdelhamid ◽  
Jeffery J Presneill ◽  
Lisa Beach ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hospital Discharge ◽  
Orange Juice ◽  
Major Trauma ◽  
Oral Intake ◽  
Randomised Clinical Trial ◽  
Feasibility Trial ◽  
Trauma Patients ◽  
Icu Discharge ◽  
The Impact

Abstract BackgroundThere are no therapies proven to diminish the muscle wasting that occurs in patients after major trauma who are admitted to the Intensive Care Unit (ICU). β-Hydroxy-β-Methylbutrate (HMB) is a nutrition intervention that may attenuate muscle loss and, thereby, improve recovery. The primary aim of this study is to determine the feasibility of a blinded randomised clinical trial of HMB supplementation to patients after major trauma who are admitted to the ICU. Secondary aims are to establish estimates for the impact of HMB when compared to placebo on muscle mass and nutrition-related patient outcomes.MethodsThis prospective, single centre, blinded, randomised, placebo controlled, parallel group, feasibility trial with allocation concealment will recruit 50 participants over 18 months. After informed consent, participants will be randomised [1:1] to receive either the intervention (three grams of HMB dissolved in either 150ml of orange juice for those allowed oral intake or 150ml of water for those being enterally fed) or placebo (150ml of orange juice for those allowed oral intake or 150ml of water for those being enterally fed). The intervention will be commenced in ICU, continued after ICU discharge and ceased at hospital discharge or day 28 post randomization, whichever occurs first. The primary outcome is the feasibility of administering the intervention. Secondary outcomes include change in muscle thickness using ultrasound, and other nutritional and patient-centred outcomes. DiscussionThis study aims to determine the feasibility of administering HMB to critically ill multi-trauma patients throughout ICU admission until hospital discharge. Results will inform design of a larger randomised clinical trial. Trial registrationThe protocol is registered with Australian New Zealand Clinical Trials Registry (ANZCTR) ANZCTR: 12620001305910, registered 02/12/2020 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380744&isReview=true. UTN: U1111-1259-5534

scholarly journals Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients

2019 ◽  
Vol 6 (1) ◽  
pp. e000383 ◽  
Author(s):  
Michelle E Kho ◽  
Alexander J Molloy ◽  
France J Clarke ◽  
Julie C Reid ◽  
Margaret S Herridge ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Function ◽  
Hospital Discharge ◽  
Randomised Clinical Trial ◽  
Consent Rate ◽  
Main Trial ◽  
Intervention Delivery ◽  
Icu Admission ◽  
Icu Discharge ◽  
Pilot Rct

IntroductionAcute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient’s ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients.MethodsWe conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1–2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge).ResultsBetween 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded.DiscussionOur pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible.Trial registration numberNCT02377830.

Impact of 24/7 Onsite Emergency Radiology Staff Coverage on Emergency Department Workflow

2021 ◽  
pp. 084653712110238
Author(s):  
Francesco Macri ◽  
Bonnie T. Niu ◽  
Shannon Erdelyi ◽  
John R. Mayo ◽  
Faisal Khosa ◽  
...  
Keyword(s):  
Emergency Department ◽  
Major Trauma ◽  
Patient Flow ◽  
Interrupted Time Series ◽  
Trauma Patients ◽  
Linear Regression Models ◽  
High Acuity ◽  
Time Series Approach ◽  
Comparison Series ◽  
The Impact

Purpose: Assess the impact of 24/7/365 emergency trauma radiology (ETR) coverage on Emergency Department (ED) patient flow in an urban, quaternary-care teaching hospital. Methods: Patient ED visit and imaging information were extracted from the hospital patient care information system for 2008 to 2018. An interrupted time-series approach with a comparison group was used to study the impact of 24/7/365 ETR on average monthly ED length of stay (ED-LOS) and Emergency Physician to disposition time (EP-DISP). Linear regression models were fit with abrupt and permanent interrupts for 24/7/365 ETR, a coefficient for comparison series and a SARIMA error term; subgroup analyses were performed by patient arrival time, imaging type and chief complaint. Results: During the study period, there were 949,029 ED visits and 739,796 diagnostic tests. Following implementation of 24/7/365 coverage, we found a significant decrease in EP-DISP time for patients requiring only radiographs (-29 min;95%CI:-52,-6) and a significant increase in EP-DISP time for major trauma patients (46 min;95%CI:13,79). No significant change in patient throughput was observed during evening hours for any patient subgroup. For overnight patients, there was a reduction in EP-DISP for patients with symptoms consistent with stroke (-78 min;95%CI:-131,-24) and for high acuity patients who required imaging (-33 min;95%CI:-57,-10). Changes in ED-LOS followed a similar pattern. Conclusions: At our institution, 24/7/365 in-house ETR staff radiology coverage was associated with improved ED flow for patients requiring only radiographs and for overnight stroke and high acuity patients. Major trauma patients spent more time in the ED, perhaps reflecting the required multidisciplinary management.

The impact of virtual admission on self-efficacy in patients with chronic obstructive pulmonary disease - a randomised clinical trial

2014 ◽  
Vol 23 (21-22) ◽  
pp. 3124-3137 ◽  
Author(s):  
Christina Emme ◽  
Erik L Mortensen ◽  
Susan Rydahl-Hansen ◽  
Birte Østergaard ◽  
Anna Svarre Jakobsen ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Clinical Trial ◽  
Pulmonary Disease ◽  
Self Efficacy ◽  
Randomised Clinical Trial ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
The Impact

Restrictive vs liberal oxygen for trauma patients‐the TRAUMOX1 pilot randomised clinical trial

2019 ◽  
Author(s):  
Josefine S. Baekgaard ◽  
Dan Isbye ◽  
Camilla Ikast Ottosen ◽  
Mo Haslund Larsen ◽  
Jakob Hessel Andersen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Clinical Trial ◽  
Trauma Patients

scholarly journals Missed orthopaedic injuries in adult trauma patients at a major trauma centre

2020 ◽  
Author(s):  
Christopher David Roche
Keyword(s):  
Major Trauma ◽  
Whole Body ◽  
Trauma Patients ◽  
Injury Incidence ◽  
Injury Rates ◽  
Missed Injuries ◽  
Missed Injury ◽  
Radiology Reports ◽  
Trauma Networks ◽  
The Impact

IntroductionDespite advances in trauma care, missed injury remains a significant cause of morbidity and mortality in trauma worldwide. In England, few have published their missed injury rates and there are no recent data for London. In 2010 London trauma networks were restructured and the impact on missed injury rates is not known. This study aimed to determine the incidence of missed orthopaedic injury for adult trauma patients at St George’s Hospital, London, and to analyse missed injuries and comment on risk factors.MethodTrauma patients were recorded prospectively at the daily trauma meeting from July to September 2012. The researcher attended clinical activities and reviewed the patient notes and radiology reports daily whilst each patient was an inpatient until discharge. Missed injuries were defined as fractures or dislocations discovered more than 12 h after arrival in the emergency department. The notes for missed injury patients were reviewed again at six months. Missed injury details were recorded/analysed.ResultsThree hundred and forty three adult trauma patients were referred to trauma and orthopaedics in the three-month study period; 5 (1.5%) had a missed injury and 148 (43.1%) had an ISS>15. All missed injuries occurred in these major trauma patients, giving an incidence of 5/148 (3.4%). Four were extremity injuries and one was cervical. All missed injury patients had a GCS of 15/15, were admitted outside normal working hours, were direct admissions and had whole-body CT.ConclusionsAt 3.4% our missed injury incidence is comparable to those published from similar major trauma centres. This provides recent London data following the restructuring of trauma networks.

Principles of trauma management

2018 ◽  
pp. 151-160
Author(s):  
Abdullah Jibawi ◽  
Mohamed Baguneid ◽  
Arnab Bhowmick
Keyword(s):  
Major Trauma ◽  
Trauma Team ◽  
Trauma Patients ◽  
Trauma Management ◽  
Economic Output ◽  
Specific Organ ◽  
Life Threatening ◽  
Clinically Significant ◽  
The Impact

Major trauma is defined as an injury or a combination of injuries that are life-threatening and could be life changing because it may result in long-term disability. The impact of trauma is huge. Injuries from accidental trauma worldwide causes moderate to severe disability in > 45m people each year. Trauma is the biggest killer of people age < 45y. UK annual trauma cost is ~£0.35b in immediate treatment; subsequent financial costs are unknown. UK annual lost economic output due to major trauma is ~£3.5b. Trauma management is challenging. Up to 40% of trauma patients have injuries that are initially missed, and up to 20% of these are clinically significant. The trauma team should be appropriately formed to achieve the assigned level of care and prioritize management. Guidelines for specific organ trauma management should be followed and practice standardized to ensure the best outcome.

scholarly journals 64 The Impact of Inadequate Pain Control Following Chest Trauma on The Incidence of Hospital Acquired Pneumonia and Hospital Admission Length

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
W Butterworth ◽  
O T Ong ◽  
O Magar ◽  
J Bird ◽  
R Scannell
Keyword(s):  
Patient Outcomes ◽  
Pain Control ◽  
Major Trauma ◽  
Chest Trauma ◽  
Trauma Patients ◽  
Permanent Disability ◽  
Retrospective Audit ◽  
Hospital Acquired Pneumonia ◽  
Hospital Acquired ◽  
The Impact

Abstract Introduction The National Audit Office (2010) report estimated there was 20,000 cases of major trauma per year in England; of which 5,400 died and many others sustaining permanent disability. Blunt chest wall injuries are associated with high levels of morbidity and mortality, and we aimed to investigate the impact of poor pain control in patient outcomes. Method Compliance with trust guidelines was assessed via a retrospective audit of all chest trauma patients between October 2019-20. Results 28 chest trauma patients identified (M:F 15:13) with ages ranging from 47-94 yrs old (average age 73). Chest trauma was associated with high levels of morbidity (32%) and mortality (7%). 39% patients were found to have inadequate pain control. Only 17% patients eligible for regional anaesthetic blocks were performed within 24hrs. 33% patients developed hospital acquired pneumonias (HAP), of which 44% had received inadequate pain control. Average admission length of patients with a HAP was 15 days compared to 5 days without. 85% patients experienced either delayed or no assessment by specialist teams (i.e., physiotherapy, pain team). Conclusions Chest trauma patients often receive inadequate pain control and delayed specialist team input resulting in increased frequency of HAPs, admission length and morbidity/mortality.

scholarly journals An Internet-Based Emotion Regulation Intervention Versus no Intervention for Nonsuicidal Self-Injury in Adolescents: Study Protocol for a Feasibility Trial

2020 ◽  
Author(s):  
Britt Reuter Morthorst ◽  
Lotte Rubæk ◽  
Jane Lindschou ◽  
Janus Christian Jakobsen ◽  
Christian Gluud Christian Gluud ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emotion Regulation ◽  
Specific Treatment ◽  
Online Intervention ◽  
Randomised Clinical Trial ◽  
Individual Therapy ◽  
Feasibility Trial ◽  
Treatment Needs ◽  
Treatment As Usual ◽  
Self Injury

Abstract Background: Non-suicidal self-injury (NSSI) has gained increased attention in recent years due to increased prevalence, especially among adolescents. Evidence-based interventions for NSSI are sparse. Emotion regulation individual therapy for adolescents (ERITA) is an online intervention that needs investigation. Non-randomised studies suggest ERITA improves emotion regulations skills and reduces NSSI frequency. Before conducting a large pragmatic randomised clinical trial, we aim to investigate the feasibility of ERITA in Denmark. Methods: A randomised, parallel group feasibility trial comparing ERITA as add on to treatment as usual versus treatment as usual in 30 adolescents age 13-17 years with recurrent NSSI referred to outpatient clinics in The Child and Adolescent Mental Health Services in the Capital Region of Denmark. Feasibility outcomes are 1) completion of follow-up, 2) the fraction of eligible participants who consent to inclusion and randomisation, and 3) compliance with the intervention. Exploratory clinical outcomes such as self-injury frequency and the ability to regulate emotions will be investigated exploratorily. Discussion: Internet-based interventions are assumed to be appealing to adolescents by being easily accessible and easy to navigate by tech natives. Disclosure of self-injury behaviour may be facilitated by an online intervention. The evidence for self-injury specific treatment needs to be extended but prior to a large clinical trial, the feasibility of methods and procedures must be assessed. Trial registration: ClinicalTrials.Gov Identifier: NCT04243603

scholarly journals An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Markus Harboe Olsen ◽  
Britt Morthorst ◽  
Anne Katrine Pagsberg ◽  
Michella Heinrichsen ◽  
Bo Møhl ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emotion Regulation ◽  
Statistical Analysis ◽  
Randomised Clinical Trial ◽  
Statistical Analysis Plan ◽  
Feasibility Trial ◽  
Treatment As Usual ◽  
Link Type ◽  
Self Injury ◽  
Statistical Report

Abstract Background Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors of later suicidal behaviour and death by suicide. The TEENS feasibility trial was initiated to assess the feasibility and safety of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as an add-on to treatment as usual in 13–17-year-old patients with NSSI referred to the Child and Adolescent Mental Health Services. Methods The TEENS feasibility trial is a randomised clinical trial with a parallel-group design. The trial intervention is an 11-week online therapy which is tested as an add-on to treatment as usual versus treatment as usual. The primary feasibility outcomes are the fraction of participants who (1) completed 12 weeks of follow-up interview or assessment, (2) consented to inclusion and randomisation out of all eligible participants, and (3) were compliant with the experimental intervention, assessed as completion of at least six out of eleven modules in the programme. Since this is a feasibility trial, we did not predefine a required sample size. The exploratory clinical outcome, the frequency of NSSI episodes, assessed using Deliberate Self-Harm Inventory – Youth version (DSHI-Y), at the end of intervention, is planned to be the future primary outcome in a larger pragmatic definitive randomised clinical trial. After completion of the feasibility trial, blinded data will be analysed by two independent statisticians blinded to the intervention, where ‘A’ and ‘B’ refer to the two groups. A third party will compare these reports, and discrepancies will be discussed. The statistical report with the analyses chosen for the manuscript is being tracked using a version control system, and both statistical reports will be published as a supplementary material. Based on the final statistical report, two blinded conclusions will be drawn by the steering group. Discussion We present a pre-defined statistical analysis plan for the TEENS feasibility trial, which limits bias, p-hacking, data-driven interpretations. This statistical analysis plan is accompanied by a pre-programmed version-controlled statistical report with simulated data, which increases transparency and reproducibility. Trial registration ClinicalTrials.govNCT04243603. Registered on 28 January 2020

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