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Trauma clinical trials

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NCT ID: NCT04642807 Recruiting - Trauma Clinical Trials

Management of Type 1 Supracondylar Humeral Fractures

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

This study compares the clinical outcomes of treating pediatric Type 1 supracondylar fracture with a long arm soft cast and no clinical or radiographic follow-up versus the standard treatment in a long arm cast with clinical follow-up. This is the first multicenter randomized control trial looking at the clinical effectiveness, safety and parental satisfaction of managing inherently stable Type I supracondylar fractures without clinical or radiological follow-up. If found to be safe; children can be managed effectively without in-person follow-up, freeing clinic appointments to children on the waiting list and in these COVID times avoiding unnecessary contacts.

NCT ID: NCT04611425 Completed - Stroke Clinical Trials

REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19: REHSCU Study

REHSCU
Start date: November 30, 2020
Phase: Phase 2
Study type: Interventional

The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short half-life) in the critical care units of Nantes University Hospital during the COVID-19 pandemic.

NCT ID: NCT04597879 Recruiting - Trauma Clinical Trials

Impact of Severe Brain Injury on Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.

MicroTC
Start date: August 1, 2021
Phase:
Study type: Observational

Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults, but its peripheral vascular consequences in humans are poorly understood. This prospective, monocentric, pathophysiological study aims to investigate differences in vasoreactivity in the anterior aspect of the contralateral forearm at the most injured cerebral hemisphere between patients with severe head trauma and patients with severe trauma without associated brain injury matched on sex and age (+/- 5 years).

NCT ID: NCT04588311 Recruiting - Clinical trials for Traumatic Brain Injury

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

EPO-TRAUMA
Start date: November 9, 2020
Phase: Phase 3
Study type: Interventional

The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.

NCT ID: NCT04577924 Completed - Trauma Clinical Trials

Pre-hospital Care Profile of Road Traffic Injury Victims- Kerala

PCP-K
Start date: January 1, 2019
Phase:
Study type: Observational

Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI.There is a lack of research on the effectiveness of pre-hospital care in Kerala. This study aimed to describe the prehospital care of RTI victims presenting to the emergency department in Jubilee Mission Medical College and Research Institute, Thrissur.

NCT ID: NCT04577196 Not yet recruiting - Critical Illness Clinical Trials

Improving Situational Awareness Before Acute Care

IMPULSE
Start date: November 1, 2020
Phase:
Study type: Observational [Patient Registry]

This study aims to assess the impact on the trauma team's situational awareness of using a dashboard to synthesize and disseminate available information on a critical patient incoming to the trauma center.

NCT ID: NCT04574466 Completed - Depression Clinical Trials

Scaling-up Psychological Interventions With Syrian Refugees in Switzerland (STRENGTHS_CH): RCT

Start date: August 25, 2020
Phase: N/A
Study type: Interventional

The current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological well-being, as well as on the healthcare systems of countries hosting refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the specific psychological treatment due to a lack of specialists. To address this problem the WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people in communities affected by adversity. The effectiveness and implementation of PM+ has never been examined in Switzerland before, this is the aim of the current randomized controlled trial.

NCT ID: NCT04572022 Not yet recruiting - Trauma Clinical Trials

Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice

Start date: December 2023
Phase: N/A
Study type: Interventional

Proximal humerus fracture patient's upper limb complete function restoration mainly depends on patient rehabilitation exercises. One time teaching in clinic is usually not sufficient for patients to learn their rehabilitation exercises. This leads to delayed patient recovery and dis-satisfaction to treatment provided by health care providers. Our aim is that mobile health technology might facilitate patient to easily access health related teaching information other than routine care to support patient in their self-health care management thus leading to proximal humerus fracture patient treatment outcome improvement. Hypothesis: Mobile health technology positively improves clinical and functional outcomes of proximal humerus fracture using validated outcome scoring scales. Objectives: Primary objective: 1. To improve adult proximal humerus fracture patient's clinical and functional outcomes using validated outcome scoring scales resulting in timely recovery with the help of patient self-health care capacity using mobile health app. 2. To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care. Secondary Objective: To increase patient and doctor satisfaction rate in perspective with treatment provision usefully by digital technology application. Methods: Study design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled trial. Total 60 subjects required with 30 in each arm in 24-month duration. Study procedures: 1. Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents/surgeon. 2. Patients of 18 to 58 years of age with trauma associated proximal humerus fractures, who or their attendants are willing to participate. Patients who requires special care, patient not willing to exercise at home without physiotherapist support or participate in survey questionnaire and patients who does not have facility of classic blue tooth connectivity will be excluded. 3. Written informed consent will be administered the study subjects as per GCP guideline. 4. Each eligible patient will be randomized into intervention or control group. 1. Intervention group: Classic Blue tooth technology will be utilized for interoperable solution of teaching video information sharing from doctor to patient. The end users will be enrolled trauma associated proximal humerus fracture patients whether treated surgically or conservatively. 2. Control group: Routine care will be provided to control group and as per routine. 5. The patient will be followed at 6 weeks, 3 and 6 months. Data will be collected on Case report form by assigned person. Clinical and functional outcomes will be assessed by assigned person using Quick DASH and Oxford shoulder score. 6. Researchers will be trained on data collection form prior to data collection. In case of lost to follow-up, patients will be contacted by telephone. 7. Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes. 8. Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes. 9. The research study does not seem to have any potential health hazard. As per Food and Drug Administration and GCP recommendations for Serious/Adverse event (SAE/AE), any patient who experience SAE/AE, will receive good clinical care at earliest and all relevant reporting bodies will be notified. 10. Data management will be carried out at the Department of Surgery. Subject data confidentiality will be maintained. After study completion, data will be archived and retained for maximum years. Statistical Consideration: Quantitative variables will be expressed as mean ± standard deviation and qualitative variables as frequencies (percentages). The efficacy on the basis of clinical and functional outcome and the AEs/SAEs will be assessed by intention to treat analysis. For group comparisons of clinical and functional categorical outcomes, chi-square test or Fisher Exact will be applied. p-values of less than 0.05 will be considered as statistically significant with a confidence interval of 95%. Patient and doctor satisfaction scores will be analyzed using regression analysis. For Assessment of outcomes, repeated measure ANOVA and generalized estimating equation will be used. Multiple regression will be used to assess the association between multiple covariates.

NCT ID: NCT04558281 Terminated - Anesthesia Clinical Trials

Continuous Erector Spinae Plane Blocks for Rib Fractures

Start date: May 23, 2021
Phase: Phase 4
Study type: Interventional

Rib fractures are one of the most common injuries in trauma patients. These fractures are associated with significant pain as well as decreased ability to inspire deeply or cough to clear secretions, which together lead to complications of the lungs and breathing which leads to risks of further injury and even death. One recent study found that the ability to move air into and out of the lungs practically doubled with the administration of a single-injection Erector Spainae Plane Block (ESPB) while pain levels nearly halved. However, a single-injection nerve block lasts less than 24 hours while a perineural local anesthetic infusion (also termed a "continuous peripheral nerve block") may be administered for multiple days. This entails inserting a tiny tube through the skin and into the area around the nerves, after which more local anesthetic may be administered prolonging the numbing effects. The possibility of extending the duration of a ESPB with local anesthetic administration via a perineural catheter has not be investigated. We therefore are conducting a randomized, triple-masked, placebo-controlled, parallel-arm study to investigate the addition of a continuous ESPB to a single-injection ESPB following traumatic rib fractures. The primary outcome of this study will be the maximum inspired volume measured by incentive spirometry on the afternoon following the nerve block procedure. We hypothesize that the maximum inspired volume will be significantly increased in the afternoon following the procedure with the addition of a continuous ESPB to a single-injection ESPB.

NCT ID: NCT04540939 Completed - Trauma Clinical Trials

Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for PTSD - COVID Related Substudy

Start date: October 19, 2020
Phase: N/A
Study type: Interventional

This clinical trial is a sub-study to treat participants that were not eligible in the main study (HUM00152509/NCT03874793) to receive MBCT or MRT in hard hit COVID-19 areas with trauma history and current COVID-related distress. The purpose of this treatment-only sub-study is to see how eligible participants with life history of any trauma and are currently experiencing elevated COVID-related stress are affected by two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy. The targeted individuals will reside in areas (Washtenaw, Wayne, and Oakland counties in Michigan, etc.) that have been affected by COVID-19. Participants will have assessments before and after 8 weeks of therapy (remote MBCT or MRT).