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Trauma clinical trials

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NCT ID: NCT02353793 Completed - Trauma Clinical Trials

Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket

Start date: April 2015
Phase: N/A
Study type: Interventional

Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.

NCT ID: NCT02344069 Completed - Trauma Clinical Trials

Pilot Randomized Trial of Fibrinogen in Trauma Haemorrhage

Start date: February 2015
Phase: Phase 2
Study type: Interventional

Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage needing haemostatic resuscitation - a randomized, controlled, double-blinded investigator-initiated pilot trial

NCT ID: NCT02303613 Completed - Trauma Clinical Trials

A Validation of Current Hospital Triage Performance System Versus RETTS

HTPS
Start date: November 2014
Phase: N/A
Study type: Observational [Patient Registry]

Background: Triage in the emergency department (ED) together with initial assessment is used to identify patient's level of urgency and treatment based on their triage level. Triage in the ED is a complex decision-making process, and several triage scales have been designed as decision support systems to guide the triage nurse to a correct decision. Worldwide there are four well known five-level triage systems in use. In 2010, 97% of all EDs in Sweden introduced a process-oriented triage scale with physiological parameters called Rapid Emergency Traige and Treatment System (RETTS). RETTS has two main assessment variables: vital signs and chief complaints, which describe the incident or symptoms that caused the patient to seek care. These two variables are evaluated and results in a color coded 5-level scale. Each level of priority has a defined time limit within which evaluation by a doctor should begin. Although, all international triage system guidelines seem to function well in western countries, they are difficult to implement and have a high failure rate in developing low-income countries. One of the reasons may be the lack of extensive training. Teaching and assessing abilities in performing mass casualty triage in inherently challenging due to the inability to accurately replicate a given disaster environment in a comprehensive way. Disaster drills and simulation exercises are ways of training triage performance and there are different tools available. One tool that can contribute to this kind of training may be the Emergo Train System® (ETS). ETS or similar interactive educational simulation systems could be used to test and evaluate incident and command systems, surge capacity, hospital preparedness and triage. Study objective study III: The aim of the study is to validate the currently practiced system for triage in the ED in Moi Teaching and Referral Hospital in Eldoret, Kenya with RETTS. Furthermore map the current patient outcome of trauma patients.

NCT ID: NCT02246972 Completed - Trauma Clinical Trials

BraveMind: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy

Start date: May 2015
Phase: Phase 2
Study type: Interventional

The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users. The following hypotheses will be tested: 1. Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates that are similar to existing Prolonged Exposure (PE) therapy delivered in military samples (20-40%) and by the absence of any critical incidents. 2. Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and psychophysiological measures) following treatment. 3. Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological measures) compared to wait-list results.

NCT ID: NCT02240732 Completed - Osteoarthritis Clinical Trials

Surgical Tourniquets and Cerebral Emboli

Start date: September 2014
Phase: N/A
Study type: Observational

BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England, Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative tourniquet can therefore help to improve the surgical field of view. Although the majority of surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are now not pursuing these devices. There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet is used for TKR surgery. In addition embolic material in the venous system have been observed following TKR surgery and have been noted to be present in the right atrium with transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood. Fat embolism syndrome and post-operative confusion in TKR patients may be the result of emboli formed during a TKR. , AIM - Is there evidence of emboli entering the cerebral circulation following tourniquet deflation in TKR surgery? - Is there evidence of MRI detectable brain lesions and or any clinical change in cognition compared in patients undergoing TKR surgery with a tourniquet compared to those that do not have a tourniquet?

NCT ID: NCT02229305 Completed - Depression Clinical Trials

Maine Implementation Study - Phase III

Start date: December 2008
Phase: N/A
Study type: Interventional

This study focused on youths who were referred to community-based mental healths clinics for problems related to disruptive behaviors, depression, anxiety, traumatic stress, and any combination of these problems. Therapists were randomly assigned to deliver usual treatment procedures (usual care, or UC) in their clinics or an evidence-based, modularized treatment (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems, or MATCH-ADTC). Assessments were conducted at pre-treatment and post-treatment, and every 3 to 6 months for two years. Results will address critical questions about deployment of evidence-based youth practices to clinical settings.

NCT ID: NCT02227979 Completed - Trauma Clinical Trials

Effects of PURPLE Cry Intervention

Start date: September 2013
Phase: N/A
Study type: Interventional

The proposed study is designed to investigate whether the PURPLE Crying program attains efficacy by optimizing the neural response in the anterior insula, and augmenting activity in regions of the brain known to be important for emotion regulation. The aim is to determine the effects of the PURPLE Cry Intervention by investigating the following: - independent variables that may affect a father's neural response to infant cries - effects of the PURPLE cry intervention, compared to a control intervention, on fathers' reported aversiveness and empathy in response to cry stimuli - effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural response to unknown infant cries compared to a tone control - effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural responses to own infant cries compared to unknown infant cries The investigators hypothesize: - prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be modulated by the following variables: subjective self-reported emotional reaction to cry stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant temperament, life stressors, parental expectations, personality (neuroticism), and father's own childhood experience - fathers who receive the PURPLE material compared to those that receive the control intervention will report a larger decrease in aversiveness and a larger increase in empathy in response to cry stimuli - fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger decrease in activity in the anterior insula and amygdala in response to cry stimuli - fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger increase in activity in regions of the brain important for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC - fathers' neural activity in the amygdala in response to their own infant's cry stimuli will be positively correlated with both their own and infant testosterone levels

NCT ID: NCT02221115 Completed - Trauma Clinical Trials

A Survey of Google Glass by Orthopaedic Trauma Patients and Surgeons

GoogleGlass
Start date: August 2014
Phase: N/A
Study type: Interventional

Patients seen in the Orthopaedic Trauma clinic will be asked to consent for potential video/picture recording using the Google Glass device during their visit with the orthopaedic surgeon or resident. The investigators want to record the patient's level of acceptance and response to this new technology. There are two arms: Patients seen by a doctor wearing the Google Glass device and those that will not be exposed. Both groups will be asked to complete a survey after their clinic visit. The device users (doctor) will complete a survey which will evaluate how effective this new tool is in the Orthopaedic clinical setting.

NCT ID: NCT02208817 Completed - Trauma Clinical Trials

The Paediatric Refill Study (PRefill)

PRefill
Start date: August 2014
Phase: N/A
Study type: Observational

2 recent national reports 'Why Children Die' and 'Are we there yet?'identified deficiencies in recognising and managing sick children. Key recommendations from both reviews included the development and adoption of 'track and trigger' or a paediatric early warning score (PEWS) to better identify the sick or deteriorating child. PEWS tools offer the potential to identify and respond sooner to clinical deterioration. Capillary refill time (CRT) is a measure of skin blood flow and is a vital part of many early warning and resuscitation scores. It is a sensitive marker of infection and dehydration in children. However, due to how it is performed and interpreted CRT is prone to marked variability between observers. We have Medical Research Council (MRC) funding to develop an automated capillary refill device and user interface to provide a paediatric continuous early warning (PaedCEW) monitoring system. The PaedCEW system would complement and support current clinical practice and aim to address the difficulties of recognising ill children. We aim to recruit 20 ill children on the Paediatric Intensive Care Unit (PICU) with 2 matched controls without significant illness from the Nottingham Children's Hospital. The 20 ill children will have their CRT (and PaedCEW score) monitored before, during and after admission to PICU. This will allow correlation with invasive (BP, central venous oxygen saturations, lactate) and noninvasive (CRT, heart rate, cardiac output) measures of cardiovascular status during periods of stability and compromise. Matched controls will be monitored for around 24 hours. This pilot study will allow development of our system. This is a proof of concept study. This study aims to demonstrate a novel device for measuring CRT. Its correlation with noninvasive measures of cardiovascular status will enable a pragmatic comparison with current clinical practice. In addition, correlation with invasive measures of cardiovascular status will enable us to calculate sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV).

NCT ID: NCT02203968 Completed - Trauma Clinical Trials

Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)

FiiRST
Start date: October 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Trauma is the leading cause of death in people 44 years of age or younger. After major trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting defects is responsible for most of deaths in the first hours of hospital admission. Of note, these bleeding-related deaths are potentially preventable. Accordingly, the initial in-hospital management of severely injured patients focuses on stopping bleeding, replacing blood loss and correcting clotting defects. Recently, animal and human research demonstrated that one of the major clotting defects following injury and bleeding is the drop in blood levels of fibrinogen (a clotting factor), which is detected on hospital admission in severely injured patients. These low fibrinogen levels are associated with increased blood transfusion and death. However, in North America, the standard of care for replacing low fibrinogen requires the use of cryoprecipitate, which is a frozen blood product with long preparation time, and similarly to other blood products, carries the risk of viral transmission and transfusion complications. Alternately, many Europeans countries where cryoprecipitate has been withdrawn from the market due to safety concerns, use fibrinogen concentrate. Fibrinogen concentrate undergoes pathogen inactivation, which is a process to eliminate the risk of transmitting viruses, bacteria and parasites, is likely a safer and faster alternative to cryoprecipitate. In Canada, fibrinogen concentrate is licensed for congenital low fibrinogen only. Although preliminary data suggest that fibrinogen supplementation in trauma is associated with reduced bleeding, blood transfusion, and death, the feasibility, safety and efficacy of early fibrinogen replacement remains unknown. We proposed to conduct a feasibility randomized trial to evaluate the use of early fibrinogen concentrate against placebo in injured patients at our trauma centre. A pilot trial is necessary to demonstrate the feasibility of rapidly preparing, delivering, and infusing fibrinogen concentrate as an early therapy to prevent excessive bleeding in trauma. This feasibility trial will provide preliminary safety and clinical outcome data to inform the design of larger trials; which ultimately aims to prevent bleeding-related deaths in the trauma population.